Industrial Training Report on RENATA LIMITED INTRODUCTION RENATA Limited (formerly Pfizer Laboratories (Bangladesh) Limited), also known as RENATA, is one of the top ten (in terms of revenue) pharmaceutical manufacturers in Bangladesh. RENATA is engaged in the manufacture and marketing of human pharmaceutical and animal health products. The company also manufactures animal therapeutics and nutrition products. RENATA currently employs about 2300 people in its head office in Mirpur, Dhaka and its two production facilities in Mirpur, Dhaka and Rajendrapur, Dhaka. BRIEF HISTORY OF RENATA LIMITED The company began its operations as Pfizer (Bangladesh) Limited in 1972. For the next two decades it continued as a subsidiary of Pfizer Corporation. However, by the late 1990s the focus of Pfizer had shifted from formulations to research. In accordance with this transformation, Pfizer divested its interests in many countries, including Bangladesh. Specifically, in 1993 Pfizer transferred the ownership of its Bangladesh operations to local shareholders, and the name of the company was changed to RENATA Limited. At present, RENATA manufactures about 300 generic pharmaceutical products including hormones, contraceptives, anti-cancer drugs, oral preparations, cephalosporins, parenteral preparations as well as other conventional drugs. In addition, they also offer about 95 animal therapeutics and nutrition products. In a gesture of corporate charity, Pfizer donated shares so that, along with a partial payment from the SAJIDA Foundation, 51% ownership of RENATA Limited would be held by the Foundation. Today SAJIDA’s microfinance and micro-insurance programs support over 107,120 members and their families; thus far cumulative loan disbursement totals BDT 5,750 million. Currently, SAJIDA’s health program covers over 1 million beneficiaries by delivering services through two 70 bed hospitals, panel doctors in SAJIDA’s micro finance branches,
Transcript
Industrial Training Report on RENATA LIMITED
INTRODUCTION
RENATA Limited (formerly Pfizer Laboratories (Bangladesh) Limited), also known as RENATA, is one of the top ten (in terms of revenue) pharmaceutical manufacturers in Bangladesh. RENATA is engaged in the manufacture and marketing of human pharmaceutical and animal health products. The company also manufactures animal therapeutics and nutrition products. RENATA currently employs about 2300 people in its head office in Mirpur, Dhaka and its two production facilities in Mirpur, Dhaka and Rajendrapur, Dhaka.
BRIEF HISTORY OF RENATA LIMITED
The company began its operations as Pfizer (Bangladesh) Limited in 1972. For the next two decades it continued as a subsidiary of Pfizer Corporation. However, by the late 1990s the focus of Pfizer had shifted from formulations to research. In accordance with this transformation, Pfizer divested its interests in many countries, including Bangladesh. Specifically, in 1993 Pfizer transferred the ownership of its Bangladesh operations to local shareholders, and the name of the company was changed to RENATA Limited.
At present, RENATA manufactures about 300 generic pharmaceutical products including hormones, contraceptives, anti-cancer drugs, oral preparations, cephalosporins, parenteral preparations as well as other conventional drugs. In addition, they also offer about 95 animal therapeutics and nutrition products.
In a gesture of corporate charity, Pfizer donated shares so that, along with a partial payment from the SAJIDA Foundation, 51% ownership of RENATA Limited would be held by the Foundation. Today SAJIDA’s microfinance and micro-insurance programs support over 107,120 members and their families; thus far cumulative loan disbursement totals BDT 5,750 million. Currently, SAJIDA’s health program covers over 1 million beneficiaries by delivering services through two 70 bed hospitals, panel doctors in SAJIDA’s micro finance branches, and mobile health teams. To date, the SAJIDA Foundation holds the majority ownership in RENATA Limited.
RENATA Ltd. has two major departments. These departments are-
Project Department
Maintenance Department
Both the departments are working effectively for the benefits of the company. The Project department is mainly concerned with the planning and international dealings. The Maintenance department generally involves ensuring proper operation and control of engineering aspects.
CORE TEAMS OF RENATA Ltd.
The following are regarded as the core teams of the running company:
Production Department:
This department determines the market demand and ensures that product is manufacture accordingly.
Quality Assurance:
The function of this department is cross checking. The department also ensures quality of every product by quality control. It runs the laboratory for this purpose. QA is a batch process; rather than a continuous one.
Engineering Department:
This department maintains the factory. It falls within the Maintenance Department.
FACILITIES AT A GLANCE
General Facility (Mirpur, Dhaka)Area: 196,730 SFT or 18,277 m2
The bottom floor is the ‘Commercial Floor’. All the production under General Plant-1 is carried out here. This building also accommodates the PPF-1.5 Facility. The generators and the majority of the electrical power distribution system are located here. This floor also has a small workshop.
The upper floor is called ‘Service Floor’. The entire utility section is on this floor. The HVAC system including the ducts, water treatment plant and pipelines, boiler, air compressor electrical sub distribution boards etc. all are to be found on this floor.
The laboratory under QA is on the second floor.
The QA office is on the third floor.
The cooling tower is on the roof of the General Plant building.
MACHINES USED IN GENERAL PLANT -1:
Serial # Type of machinery Numbers1 Sealing Machine 92 Labeling Machine 53 Tablet Press 134 Blender 45 Dry powder Filling 4
The basic production procedure of the important products in the general plant was studied. The procedures can be divided into four major groups. These are:
Tablet Production Capsules Production Dry Sirup Production Production of Injectable etc.
MANUFACTURING PROCEDURE OF TABLETS:
Tablets of a variety of groups and types and sizes are produced in the general plant. This is done on a number of tablet compression stations. The overall Tablet making process can be divided into four stages. These stages are:
Granulation or Preparation of Material Compression Coating Blistering etc.
These processes are described below:
GRANULATION:Before tablet compression, the raw materials are passed either in the wet granulation or dry mass process. For wet granulation, the raw materials are initially mixed for about 20 minutes and then a binder is applied in the mixer and a lump is obtained thereby. Common binding agents are:
Mild Starch paste
Probiton-K
The lump or crystallized raw material is then passed through the “Fitz Mill” for sieving and then to the dryer. Drying is done for about 20 -30 min at 60-70˚C.
Some lubricants are used such as:
Sodium Lauryl Sulphate
Talcom Powder
Magnesium Stearate
Dry mass production is done on the oscillating granulator, and the product is obtained directly.
PROCESS FLOW CHART:
Figure: Flow chart for Granulation
COMPRESSION:
Raw Material Mixing
Preheating Binder Adding Lump Created
SievingDryingDispensing
There are different tablet compression machines of varying capacities. The method incorporated by the machines is forming using die and punch. The machines available for this purpose are listed below:
Cadmach 12
Cadmach 25
Cadmach 49
Sejong 37(1)
Sejong 37(2)
Sejong 51
Adept 25
Adept 23 etc.
The number written after the manufacturer’s name indicates the number of dies or stations available in the machine. The more this number is the more is the production rate. One sample specification of a SEJONG 37 machine given below:
SPECIFICATION:
o Electrical specifications: 400V / 50Hz / 3Phaseo Number of station: 37o Rpm of disk: 3-60 rpmo Power of main motor: 15Hp (11KW)o Machine floor space: 1150 * 1550 mmo Weight of machine: 4000 kg
PROCESS FLOW CHART:
Figure: Flow chart for Compression.
COATING:These machines are designed for tablets, pillets, granule type object coating. It is done by compressed air fundamentally. Some machines are;
Sejong(2 guns)
Sejong(4 guns)
Glatt(6 guns)
One sample specification of a SEJONG 37 machine given below:
Powder Inlet to Hopper
Filling Product Output
Compression by Die Punch
Pump Specification:o Speed: 220 rpmo Voltage: 100-120 Vo Frequency: 50 Hz o Current: 1.25 A
Spray gun Specification:o Mach 1A HVLo Air nozzle: Inlet: 2 psi Atomizing: 3 psio Fluid nozzle: Inlet: 5 psi Atomizing: 2 psi o Control: PLC, touch screen.o Power supply: 100 - 150 W
BLISTERING:There are blistering machines of various capacities, models and control systems. Some are fully automatic, some requires human intervention.
Al-Al blistering and Al-PVC blistering is of same principle, but in case of PVC it needs two additional heating stations for sealing. This is due to the fact that two metal strips of Aluminum under sufficient pressure and machining process can get sealed without any additional high temperature provision.
For Blistering, at first PVC or Aluminum Sheet is taken which is then heated by a heater, known as a pre heater. An air pocket is created by injection of compressed air. The tablets are fed into the created packet, either manually or by an automatic process. After this operation, another strip of Aluminum comes from the other end and sequentially sealing, slitting, cutting etc are done by different heaters with appropriate temperature. This is the basic principle of operation, which may vary from machine to machine to a certain extent.
Some blistering machines are:
Ulmann (2 pcs)
Pampac
Langnan
Buchon
One sample specification of a BUCHON machine given below:
Specification:o Manufacturer: BUCHON Machinery Co.o Model: WDER-A1Vo Type: UPS 300o Electric: 415 V, 50 Hz, 3 phaseo Rated Current:9 Ao Main motor power: 1.1 kWo Gross power for head: 2 kW
o Punching frequency: 10-30 times/mino Stroke adjusting range: 40-110 min o Preheat Temperature: 130.5˚Co Preheat Temperature: 130.5˚Co Sealing Temperature: 145.5˚Co Slitting Temperature: 100.2˚C
PROCESS FLOW CHART:
Figure: Flow chart for Blister Machine.
Flow chart for tablet manufacturing from the Batch Manufacturing Record (BMR):
PVC/Al Strip Intake
Sealing
SlittingEmbossingSealing
Heating Al strip input Tablet Filling
Air InjectionPreheating
Primary Packaging
Secondary Packaging
Hold for decision
Rejected
Wet Mass Preparation (7)
Primary Milling + Sieving (8)
Drying (9) Final Milling + Sieving (10)
Blending (11)Coating (14) Compression (13)
Accepted
QC Chec
k (12)
QC Chec
k (4)
Labeling (2) Quarantine (3)
Stored for use (5)Dispensing (6)
Good Receiving (1)
Hold for decision
Accepted Rejected
Primary Packaging (16)
Secondary Packaging (17)
Transfer to FG Store (19)
QC Chec
k (15)
QC Chec
k (18)
Hold for decision
Accepted
Accepted
Rejected
Hold for decision
Rejected
Figure: Overall Procedure including QC check and others of Tablet production
MANUFACTURING PROCEDURE OF CAPSULES:
The capsule making process has both similarity and dissimilarity compared to that of tablet from many aspects. The process is same up to dispensing stage. The rest of the process can be sub-divided into three main stages. These can listed as below:
Sieving and Blending (material preparation) Encapsulation Blistering etc.
Process under controlled humidity and temp [40-60%]
Process under ambient humidity and temp [25°C ± 2°C]
The entire granulation step required for tablet making is replaced by sieving and blending only. The final stage or blistering is similar to that of tablets. The intermediate stage or encapsulation is described below:
The mixed powder for capsules is taken into the encapsulation station which similarly produces capsules. The shells of all the capsules are not manufactured in the factory; rather they are bought from outside reliable sources as raw materials.
PROCESS FLOW CHART:
Figure: Flow chart for Encapsulation
There are several capsule processing machines. Some of these machines are automatic, rests are manual. Such as:
PTAM SA9, India
HUADA, China etc.
Flow chart for capsule manufacturing from the Batch Manufacturing Record (BMR):
Shell intake at Rake Shell Disintegration Raceway
PusherFillerProduct Output and Rejection
Labeling (2) Quarantine (3)
Stored for use (5)
Dispensing (6)Sieving (7)
Blending (8)
Primary Packaging (12)
Good Receiving (1)
QC Chec
k (4)
Secondary Packaging (13)
Transfer to FG Store
Encapsulation (10)
QC Chec
k (9)
QC Chec
k (11)
QC Chec
k (14)
Hold for decision
Hold for decision
Hold for decision
Hold for decision
Accept
Accept
Accept
Accept
Rejected
Rejected
Rejected
Rejected
Figure: Overall Procedure including QC check and others of Capsule production
MANUFACTURING PROCEDURE OF DRY SIRUP:
Production is done according to the market demand. A fully automatic machine (CVC, Taiwan) is used in this purpose.
Process under controlled humidity and temp [40-60%]
Process under ambient humidity and temp [25°C ± 2°C]
PROCESS FLOW CHART:
Figure: Flow chart for Dry Sirup Production
PROCESS IN DETAILS:
The glass bottles are fed manually into the machine first. Also the metallic cap and plastic gaskets are fed into separate stations. The dry syrup powder is fed into the machine by creating a vacuum. The bottles are taken into the line automatically at six stations simultaneously. Desired amount of dry powder is filled into each bottle in an automatic process. The bottles also vibrate here to avoid any lump creation. Little amount of Air is sprayed to move away the outside and dry powder dust from the outer periphery of the bottles.
After filling the bottles pass on a conveyor belt for the next process. There are sensors on the belt to avoid jamming.
The filled bottles then move to be sealed with plastic gaskets. The gaskets fell from top and seal each bottle automatically and sequentially move to the next station, which is Capping.
After capping is done by twisting and sealing the bottle completely, they move through the conveyor belt for next stages as labeling, primary and secondary packaging etc.
This is to be noted that there are a number of sensors at each stations, each important points on the machine to ensure that the process is running properly and if not it can reject the individual item and in fact in some cases of severe errors, the machine stops by itself to ensure highest accuracy and quality.
Maximum of 6 bottles are operated simultaneously.
Capacity of bottles: 130, 70, 35 ml
Each filling station has separate sensors.
Powder is lifted by vacuum.
Bottle installing
Conveyor Filling station
Photo sensor
sensor
Gasket sealing
CappingAir injection
Final sealing
OutputLabelingManual Check
There are a number of dampers, vacuum pumps and sensors.
The machine is made in Taiwan, by the CVC Technology Co Limited. But it uses an overall USA technological aspects and standards.
MANUFACTURING PROCEDURE OF INJECTABLE:
The products of injections are:
Liquid ampoule
Liquid vial
Dry vial
These injectables are produced with maximum precaution in the sterile area. Various ampoule washer, cleaner, sterilizer and inspection machines are used in this process. Due to entry restrictions, we could not enter them thoroughly, but yet got an overall clear idea of the entire process.
PROCESS FLOW CHART:
Figure: Flow chart for Injection production.
Flow chart for tablet manufacturing from the Batch Manufacturing Record (BMR):
Ampoule Washing
Visual Inspection
Sealing
Leak Test
Filling Filtration
Mixing of base product
Sterilization
Final product to the Packaging
Rejected
Leak Test (12) Visual Inspection (13)
Defected Ampoules Destroyed
Accepted
Accepted
Rejected
QC Chec
k (14)
Packaging (15)IPQC
Check (16)
Hold for decision
Transfer to FG Store (17) Holdi
ng decision
Rejected
Rejected
Accepted
Accepted
Accepted
Sterilization of Ampoule
Filling + Sealing (10)
Ampoule Washing by WFI
Warehouse IPQC Check
(11)
Hold for decision
Rejected
Labeling (2) Quarantine (3)Good Receiving (1)
QC Chec
k (4)
Stored for use (5)Dispensing (6) Hold for decision
Accepted Rejected
Figure: Overall Procedure including QC check and others of Injection production
UTILITY: POWER DISTRIBUTION SYSTEM
In pharmaceutical industry an essential utility is the electric power distribution to the whole industry. Electric power is distributed from the service floor according to the demand. In
Process under controlled humidity and temp [40-50%]
Process under ambient humidity and temp [25°C ± 2°C]
Reneta Limited the main power source is either from the generators or Dhaka Electric Supply Company (DESCO).
It has two generators. The power capacity of smaller one is 0.7MW and the bigger one is 1.2MW. The ON/OFF process of small generator and DESCO IS done with a separate control board. The controlling system is manual with hand lever. When the DESCO line is ON the small generator is OFF and vice versa. The big generator is controlled directly by the switch.
When the DESCO line is ON then current is passed from the transformer it goes to the main distribution board (MDB) through Low Tension Panel (LTP). If the generator is ON, the current will be passed through circuit breaker to the LTP. At last reaches the MDB from where the power requirement for the industry is maintained.
Power Source DESCO
FLOW DIAGRAM:
Figure: Flow Chart showing Power distribution from DESCO source.
DESCO:
DESCO supplies current to the different parts in the Dhaka city. The voltage of DESCO current is 11KV. But in industry the voltage requirement is 380-400V.
TRANSFORMER:
A transformer is a device that transfers electrical energy from one circuit to another through inductively coupled conductors –the transformer’s coil. A varying current in the primary winding creates a varying magnetic flux in the transformers are and thus a varying magnetic field through the secondary winding.If a load is connected to the secondary an electric current will flow in the secondary winding and electrical energy will be transferred from primary circuit through the transformer to the load. In an ideal transformer the induced voltage in the secondary is proportional to the primary voltage and is given by the ratio of no. of turns in the secondary (Ns) to the no. of turns in the primary (Np) as follows
Specification of Transformer:
Input : 11KVOutput : 440V
DESCO LTP
MDB
Switch Transformer
Sub-Distribution Board
Primary winding : Del -connectionSecondary winding : Y- connectionVector Group : DYn11
LOW TENSION PANEL:
The transformer steeped down the voltage. The low voltage is distributed from low tension panel. The bus-bars are used in RENATA limited to meet the continuous current rating and short circuit levels desired. The three phase vertical bus-bars provided are of high-conductivity, electrolytic grade copper as standard. These vertical droppers provided with round edges for ease of contact insertion. They are provided in an enclosed chamber which is located behind the feeder compartment.
The chamber is totally enclosed to prevent the entry of dust and vermin. The vertical bus-bars are accessible only after the removal of the feeder trolley and the front guard. The vertical bus-bars are free of bolts, holes etc. For connection and hence are maintenance free.FRP vertical bus-bar support are provided within the bus chamber at a distance of 100mm from each other.
Figure: Low Tension Panel
MAIN DISTRIBUTION BOARD:
It is a board from which the power is distributed to the whole industry. The location of MDB is selected very carefully. It should be located in the dry place. The main distribution board LVMD is the central switch cabinet within a hospital. In it the basic network structure for the general supply (GS) and the safety power supply (SS) are established. Due to their great
importance, there are strict requirements on the operational reliability and person and system protection. Accordingly, the system must be configured as a type-tested low-voltage switchgear and control gear assembly (TTA) according to DIN VDE 0660 Part 500, IEC 60439-1 and DIN EN 60439-1.
The solution:The main distribution boards consist of:
o Incoming/Outgoing feeders general supply (GS)o Incoming/Outgoing feeders safety power supply (SS)
Benefits:o Modular design of distribution, function systems and deviceso Individual planning, project management and execution for every individual
situationo Arc-fault safe insulation between common rail space, device space and
connection spaceo High operational reliability, personal safety, and availabilityo Construction upon request, type-tested according to DIN VDE 0660 Part
500, IEC 60439-1 and DIN EN 60439-1o Secure separation between the systems (GS and SS)
Figure: Main Distribution BoardPower Source GeneratorFLOW DIAGRAM:
Generator Switch gear
Sub Distribution
Boards
Main Distribution
Boards
Low Tension Panel (LTP)
Figure: Flow Chart showing Power distribution from GENERATOR source.
ELECTRIC GENERATOR:
Electricity generation is the process of generating electric energy from other forms of energy. For electric utilities, it is the first process in the delivery of electricity to consumers. The other processes, electricity transmission, distribution, and electrical power storage and recovery using pumped storage methods are normally carried out by the electric power industry.
In electricity generation, an electric generator is a device that converts mechanical energy to electrical energy. A generator forces electrons in the windings to flow through the external electrical circuit. It is somewhat analogous to a water pump, which creates a flow of water but does not create the water inside. The source of mechanical energy may be a reciprocating or turbine steam engine, water falling through a turbine or waterwheel, an internal combustion engine, a wind turbine, a hand crank, compressed air or any other source of mechanical energy.
Before the connection between magnetism and electricity was discovered, electrostatic generators were invented that used electrostatic principles. These generated very high voltages and low currents. They operated by using moving electrically charged belts, plates and disks to carry charge to a high potential electrode. The charge was generated using either of two mechanisms:
o Electrostatic inductiono The triboelectric effect, where the contact between two insulators leaves them
charged.
Because of their inefficiency and the difficulty of insulating machines producing very high voltages, electrostatic generators had low power ratings and were never used for generation of commercially significant quantities of electric power. The Wimshurst machine and Van de Graff generator are examples of these machines that have survived.
An engine-generator is the combination of an electrical generator and an engine (prime mover) mounted together to form a single piece of self-contained equipment. The engines used are usually piston engines, but gas turbines can also be used.
Synchronous Generators are the primary source of all electrical energy and commonly used to convert the mechanical power output of steam turbines, gas turbines, reciprocating
engines, hydro turbines and wind turbines into electrical power for the grid. They are known as synchronous generators because they operate at synchronous speed, which is the same principle of operation as a synchronous motor. The speed of the rotor with a constant magnetic field always matches supply frequency of the stationary winding. The constant magnetic field of the rotor is produced by the persistent magnetic field of a rotor permanent magnet assembly or by controlling direct current to a rotor field winding (i.e., electromagnet) fed through a slip-ring assembly or a brushless means.
Two synchronous generators are used in RENATA Limited. They are combined with engine. Generators run by diesel fuel. It has 12 V-cylinder and cooling system is provided with a radiator
o The rotor is mounted on a shaft driven by mechanical prime movero A field winding (rotating or stationary) carries a DC current to produce a constant
magnetic field.o An AC voltage is induced in the 3- phase armature winding (stationary or rotating) to
produce electrical power.o The electrical frequency of the 3-phase output depends upon the mechanical speed
and the number of poles Specifications of Synchronous Generator:
Manufacturer North Ireland/UK
Model P800
Serial No. GACL000390
Year of Manufacture 2001
Rated Power continuous:
800 KV 640 KW 0.8 cosφ
Rated voltage 400/230 V
Phase 3
Rated frequency 50 Hz
Rated current 1154.7 A
Rated RPM 1500
Maximum Altitude 152.4 m
Maximum Ambient Temperature 27˚C
Sensor PT100 (Thermal)
SWITCH GEAR:
Circuit breaker is used as switchgear in this industry. The term switchgear, used in association with the electric power system, or grid, refers to the combination of electrical disconnects, fuses and/or circuit breakers used to isolate electrical equipment. Switchgear is used both to de-energize equipment to allow work to be done and to clear faults downstream. This type of equipment is important because it is directly linked to the reliability of the electricity supply.
The very earliest central power stations used simple open knife switches, mounted on insulating panels of marble or asbestos. Power levels and voltages rapidly escalated, making open manually-operated switches too dangerous to use for anything other than isolation of a de-energized circuit. Oil-filled equipment allowed arc energy to be contained and safely controlled.
By the early 20th century, a switchgear line-up would be a metal-enclosed structure with electrically-operated switching elements, using oil circuit breakers. Today, oil-filled equipment has largely been replaced by air-blast, vacuum, or SF6 equipment, allowing large currents and power levels to be safely controlled by automatic equipment incorporating digital controls, protection, metering and communications.
High voltage switchgear was invented at the end of the 19th century for operating motors and other electric machines. The technology has been improved over time and can be used with voltages up to 1,100 kV.
Typically, switchgear in substations is located on both the high voltage and the low voltage side of large power transformers. The switchgear located on the low voltage side of the transformers in distribution type substations, now are typically located in what is called a Power Distribution Center (PDC). Inside this building are typically smaller, medium-voltage (~15kV) circuit breakers feeding the distribution system. Also contained inside these Power Control Centers are various relays, meters, and other communication equipment allowing for intelligent control of the substation.
For industrial applications, a transformer and switchgear (Load Breaking Switch Fuse Unit) line-up may be combined in one housing, called a unitized substation or USS. Different switchgear equipments are given below
o Circuit breakero Isolatoro Earthing switcho Lighting arrestoro Current transformero Voltage transformer
Functions
One of the basic functions of switchgear is protection, which is interruption of short-circuit and overload fault currents while maintaining service to unaffected circuits. Switchgear also provides isolation of circuits from power supplies. Switchgear is also used to enhance system availability by allowing more than one source to feed a load.
Safety
To help ensure safe operation sequences of switchgear, trapped key interlocking provides predefined scenarios of operation. For example, if only one of two sources of supply are permitted to be connected at a given time, the interlock scheme may require that the first switch must be opened to release a key that will allow closing the second switch. Complex schemes are possible.
Indoor switchgear can also be type tested for internal arc containment. This test is important for user safety as modern switchgear is capable of switching large currents.
Switchgear is often inspected using thermal imaging to assess the state of the system and predict failures before they occur.
The working process of low tension panel and main distribution boards is same as previously discussed when the power source is DESCO
WIRE (CABLE) SIZE SELECTION:
A wire is a single, usually cylindrical, flexible strand or rod of metal. Wires are used to bear mechanical loads and to carry electricity and telecommunications signals. Wire is commonly formed by drawing the metal through a hole in a die or draw plate. Standard sizes are determined by various wire gauges. The term wire is also used more loosely to refer to a bundle of such strands, as in 'multi-stranded wire', which is more correctly termed a wire rope in mechanics, or a cable in electricity.
Although usually circular in cross-section, wire is also made in square or flattened rectangular cross-section, either for decorative purposes, or for technical purposes.
In industry cable size selection is the most essential task. If the material from which wires are made had zero resistance, then any size wire could carry any amount of current. Considering the formula of power
……(1)
…......(2)
From equation (1) the current is determined. The value of ecal and length is obtained from cable selection chart. Using the value of current from equation (1) permissible voltage is
calculated. The maximum allowable voltage drop is 5%. If the voltage drop is below or equal to 5% then the design is ok.
ENERGY CONSUPTION:
The daily energy consumption of this industry is approximately 1.6 MW. Energy consumption is dependent on the production capacity. The production process is continuous. So the monthly energy consumption is 48 MW.
COST OF ENERGY (MONTHLY CALCULATION):
The cost of electricity generated by different sources measures the cost of generating electricity including initial capital, return on investment, as well as the costs of continuous operation, fuel, and maintenance.
Source of energy Cost (lakhs)
DESCO 26
Boiler (gas) 26
Generator (diesel) 12.5
Total = 64.5
ENERGY COST REDUCTION:
Following steps can be taken to reduce the cost of energy:
Bus-bar trunking system
Busbar trunking system (BBT) performs the function of transporting current form one point to the other. Traditionally cables were used for this function. BBT goes beyond what cables do. BBT can tap off power to switchgear for further distribution using tap of boxes. In comparison to cables, BBT can thus serve as distribution panels at different stages (at floors of a building). BBT thus continues as a single system to replace cables as well as distribution boards at floor level for building.
Effective lighting
Many LED lamps can become available as replacements for screw-in incandescent or compact fluorescent light bulbs, ranging from low-power 5–40 watt incandescent bulbs, through conventional replacement bulbs for 60 watt incandescent bulbs (typically requiring about 7 watts of power), and as of 2010 a few lamps were available to replace higher wattage bulbs, e.g., a 16-watt LED bulb which is claimed to be as bright as a 150W halogen lamp. A standard general-purpose incandescent bulb emits light at an efficiency of about 14 to 17 lumens/W depending on its size
and voltage. According to the European Union standard, an energy-efficient bulb that claims to be the equivalent of a 60W tungsten bulb must have a minimum light output of 806 lumens.
Rearranging wire system
Heavy industries have more demanding wiring requirements, such as very large currents and higher voltages, frequent changes of equipment layout, corrosive, or wet or explosive atmospheres. In facilities that handle flammable gases or liquids, special rules may govern the installation and wiring of electrical equipment in hazardous areas.
UTILITY: Heating Ventilation Air Conditioning (HVAC)
In pharmaceutical manufacturing, how space condition impacts the product being made is of primary importance. HVAC systems assists in ensuring the manufacture of quality products and also results in operator comfort. HVAC systems design influences architectural layouts, with regard to items such as airlock positions, doorways and lobbies. International guidelines are available which are approved by various organizations in the respective field. Every pharmaceutical company must choose and strictly follow any of these guidelines. Being a pharmaceutical company itself, RENATA Ltd is no exception.
FUNCTIONS OF HVAC SYSTEMS:
HVAC systems perform the following four basic functions.
Control airborne particles, dust and micro-organisms: Of all the design goals, it is the quality of air, cleanliness of the space and prevention of contamination which are of utmost importance. Externally generated particulates are prevented from entering the clean space through the use of proper air filtration.
Maintain room pressure (ΔP): Areas that must remain “cleaner” than surrounding areas must be kept under “positive” pressurization, meaning that air flow must be from “cleaner” area towards the adjoining space (through doors or other openings) to reduce the chance of airborne contamination. This is achieved by the HVAC system by providing more air into the “cleaner” space than is mechanically removed from the same space.
Maintain space moisture (relative humidity): Humidity is controlled by cooling air to dew point temperatures or by using desiccant dehumidifiers. Humidity can affect the efficacy and stability of drugs and is sometimes important to effectively mould the tablets. While most of the areas could have a RH of 50 ± 5%, facilities designed for handling hygroscopic powders need to be at 30 ± 5%.
Maintain space temperature (T): Temperature can affect production directly or indirectly by fostering the growth of microbial contaminants on workers. Yet this is the least critical parameter. Lower temperature may be required where workers are very heavily gowned and would be uncomfortable at “normal” conditions.
The design of HVAC systems should be considered at the concept design level. The efficacy of the system design is based on the proper consideration of the following factors:
Building construction and layout design Defining the HVAC requirements system-wise and room-wise
o Cleanliness levelo Room temperature, relative humidityo Room pressureo Air flow pattern
Cooling load and air flow compilation Selection of air flow pattern Pressurization of rooms Air handling system Duct system design and construction Selection, location and mounting of filtration system Defumigation required Commissioning, performance qualification and validation Testing and validation Documentation
HVAC SYSTEM IN RENATA LIMITED:
The HVAC Utility in RENATA Ltd. is operated and maintained by the Engineering Department under Maintenance. It has an overall capacity of 700 tons and the whole HVAC utility is situated on the service floor (above production floor) except the cooling tower, which is placed on the roof of the general plant building.
Guideline followed by RENATA ltd.: Currently RENATA Ltd. is following the ISO-14644 Cleanroom Classification Class 8 and BS 5295 for HVAC system design. The ISO 14644 Class 8 deals with the molecular contaminant restrictions. The ISO Classification of Cleanroom doesn’t include the operating condition of the room, i.e., “at rest” or “in operation”. Rather the criterion is the maximum concentration limits (particle/m3). The following table contains molecular contamination limits of ISO standard.
Cleanroom Zoning: There are four types of cleanroom zones in manufacturing sterilized pharmaceutical products. The grade is defined by the type of product and a part of process which needs to be protected from contamination. The zones are:
o A – local zone: For operation that affords high risk of product quality, e.g. filling, closing, ampoule and bottle opening zones. Usually in such zones is used in laminar air flow which provides similar velocity 0.36-0.54 ms-1.
o B zone: This is circled A zone and is used for an aseptic preparation and fulfillment.
o C and D zones: These are clean zones for less responsible stages of manufacturing sterilized products.
TABLE-2: Clean Zones Grades
GRADE AT REST IN OPERATIONMaximum permitted number of particles per m3 equal to or above 0.5 micron
Maximum permitted number of particles per m3 equal to or above 5 micron
Maximum permitted number of particles per m3 equal to or above 0.5 micron
Maximum permitted number of particles per m3 equal to or above 5 micron
A 3,500 0 3500 0B 35,000 0 35,000 2,000
C 350,000 2,000 350,000 20,000
D 3,500,000 20,000 Not defined Not defined
From the table, it is visible that Grade-A classification is the most stringent of all. It requires air in the immediate proximity of exposed sterilized to be no more than 3500 particulates per cubic meter, in a size range of 0.5micron and larger. In the size range of 5micron the maximum allowable limit is zero. This is the HVAC requirement for the injective products. The solid dosage area is supplied with grade-D. These products in this area require low relative humidity (<45%, best 35%, in case of sterile it is 50-60%). The contamination is of secondary importance for this grade.
Types of HVAC Systems available at RENATA LTD.:
There are two types of HVAC systems available at RENATA LTD. These are as follows:
o Central type: General plant
o Package type: Sachet filling, softgel etc.
COMPONENTS OF HVAC UTILITY:
The main components of the HVAC system are as follows:
Chiller AHU Dehumidifier Cooling Tower
Pump Ducts and pipelines etc.
FLOW PROCESS OF HVAC UTILITY:
Figure: Schematic Diagram of the HVAC System
DESCRIPTION OF THE FLOW PROCESS:
The circuit on the left of the flow diagram is the refrigerant circuit of the chiller. This is a typical refrigeration cycle comprising of components like compressor, condenser, expansion valve and evaporator.
Normal water is cooled by passing it through the evaporator where the refrigerant evaporates by extracting heat from the normal water. The refrigerant is then compressed by compressor. The superheated refrigerant then condenses in the condenser. Water from cooling tower takes way the heat. The condensed refrigerant is then expanded as it comes across a expansion valve.
The cold water from the evaporator is passed into the cooling coils of AHU. At the same time fresh air and return air is taken and mixed together at required rate. The air is then cooled as it flows over and around the cooling coils. The cold air the then supplied to the room at the required rate through ducts.
The return air after passing through the return air filter and sensor is taken into the dehumidifier. There dehumidification occurs. Finally the air is directed to the mixing chamber of the AHU.
From the diagram it is visible that the HVAC is of recirculation type, not once through air type. The advantages of this type of systems are as follows:
o Lower air filter maintenance and energy costo Opportunity of better air filtrationo Better control of parameters (T, RH)
Cooling Tower
Normal Water
Cold Water
Condenser Water
SensorDehumidifier
RoomAHU
Fresh Air
Return air
Cold Air
Return air
Return air
Compressor
Condenser
Evaporator
Freon
Expansion device
Chiller
o Less cooling or heating cost as the amount of throw-away air is less etc.
This type of system also has some disadvantages like:
o Return air ductwork to AHU may complicate the layout of service flooro There remains chance of cross-contamination etc.
Figure: Schematic of Return Air HVAC system.
CHILLER:
There are two chillers in RENATA Ltd. The manufacturer is same. The chiller supplies cold water for the AHUs’.
Mechanical parts of a Chiller: The Chiller consists of the following mechanical parts:
o Compressor o Condensero Evaporatoro Expansion valveo Oil separatoro Solenoid valveo Oil sumpo Gas pump
Specification: The specification of the chillers is given below:
o Manufacturer: TRANEo Capacity: 350 ton per chillero Full Load Current: 275-375 Ampereo Voltage: 380-440Vo Refrigerant: R-134a
The following diagram of a chiller is collected from the manufacturer’s catalogue available on internet:
A set of sample data of the chiller is given below:
Compressor Data:
o Starts: 1272o Running time: 3187.42 o System differential pressure: 106.3 psido Oil Pressure: 128.8 psigo Oil level sensor: Weto Refrigerant discharge temperature: 134.4°Fo Volts: AB BC CA
409 412 413 V
o Ampere: L1 L2 L3250 255 256 Amp
o RLA: 85.3 87.2 88.5%n (the percent of rated load amps)
AIR HANDLING UNIT OR AHU: Pharmaceutical air handling systems support clean aseptic environments, so the equipment is air tight. The air-handling unit is box-like equipment with a fan and a cooling coil inside. There are also Air Filters. The whole fan and motor assembly, comprising shaft, bearings, pulley, and belt is usually put inside the AHU. Typical the box is a metal casing, with an insulation liner applied to the inside of the casing. There are 30-35 AHUs’ in RENATA Ltd.
The basic function of the AHU is to suck air from the rooms, let it pass through chilled water cooling coils and then discharging the cooled air back to the rooms. Normally, letting it pass through panel or bag filters also filters the air. A certain amount of fresh air (10-15% of return air) is introduced at the suction duct so that air in the rooms may be gradually replaced.
Control valves are used to throttle chilled water through the chilled water coils. There is no reservoir for cooling water, the same water is circulated between chiller evaporator and AHU coils though make-up water may be added. There are also control damper to control the air supply.
The fan and motor assembly is mounted on vibration dampers that absorb any vibrations generated. Removable panels are installed so that operator can enter into the AHU for maintenance. Maintenance is mostly changing or washing of air filters, greasing of bearings, changing of belts, and general inspection and cleaning work.
An AHU has three types of filters. These are the Back filter, Pre-filter and HEPA (High-Efficiency Particulate Air) filter etc. Among these filters, the HEPA filter is most efficient one. The pre-filters are used to prolong the service life of the HEPA filters. The 0.5 micron HEPA filters used in the AHUs’ of RENATA Ltd. are the box-types. These are able to prevent microorganisms of the size 1 micron from entering the room.
Specification: The specification of the AHU motor is given below:o Power: 10Hp/7.5KW, 1450 rpm, 60Hz.o V-belt connects it to the runner of the fan.
DEHUMIDIFIER:
Dehumidifiers are used to control the relative humidity (RH) to lower levels. RH of 50±5% can be achieved by cooling the air to the appropriate dew-point temperature. When chilled water is supplied at 42-44°F to the cooling coils, a minimum dew-point of about 50-52°F can be obtained. This results in a minimum RH of 50% at 70°F.
Spaces with high moisture content, it is important to use a cooling coil that is deeper i.e. with higher number of rows. This will lead to lowering of supply air temperatures downstream the cooling coil, which is reheated by hot water coil or electric strip heaters before dumped into the space.
In some cases where hygroscopic (product sensitive to moisture) materials are handled, the room RH requirement may be as low as 30 to 35% and may require the use of chemical dehumidifiers. Both dry and wet chemical dehumidifiers are available for commercial use. Lithium salt solutions are examples of wet dehumidifiers while silica gel and activated alumna are generally used as dry dehumidifiers. The dehumidifiers used in RENATA Ltd. uses the dry ones.
The dehumidifiers in RENATA Ltd. are also metal box-like structures similar to AHUs’, but smaller. Inside the dehumidifier there is an electric heater, Silicas coil (silica being the chemical dehumidifier) and two fans. The fans are used to draw air inside.
COOLING TOWER:
There is only one cooling tower in RENATA Ltd. The cooling tower is located on the roof of the general plant building. It is a Counter-flow, Induced type cooling tower.
Counter flow cooling towers have the air passage flowing directly against the flow of the water. Water is allowed to spread out with the help of air inlet louvers. Their bottle like shape characterizes this type of cooling towers. There is only one single fan at the center. Fitted below the fan is a rotating water pipe distributor. The pipes of the water distributor shoot water only from one side. The action of the water pressure shooting from one side rotates the distributor. The water is thus dropped evenly over the air inlet louvers. The water dropping by gravity meets head on with the up moving air current sucked in by the fan. The air cools the water. The water collected at the bottom of the cooling tower is pumped to the chiller, becomes heated up again, and is then returned back to the cooling tower for cooling.
The following schematic diagram of a cooling tower:
Figure: Schematic Diagram of a Counter Flow Induced Draft Cooling Tower.
UTILITY: WATER TREATMENT PLANT
The purity of water used in pharmaceutical industries is a crucial factor that must be ensured. To provide the water of desired quality (as approved by various international guidelines such as United States Pharmacopeia or British Pharmacopeia) water treatment is carried out. The objective is to produce water keeping the following factors within the recommended limit and also to supply the required quantity:
pH Conductivity Micro Organism Content
There are two basic types of pharmaceutical water; water for typical use or cleaning (sterile purified water, or PW), or water for injection (WFI). The pH (5-7) and conductivity (0.6–4.7 µSiemens/cm) value are same for both types of water. The quality differs when Micro Organism Content is taken into account. The preferred values of MOC are 100cfu/ml for PW and 10cfu/100ml for WFI (USP guidelines).
The WFI water is passed through some higher stages of purification and the distribution of these two types of water is also kept separated.
PURIFIED WATER (PW): In RENATA Limited, there are two plants for supplying PW. These are:
The Manual plant The Automatic plant
THE MANUAL PLANT FOR PURIFIED WATER:It utilizes the method of Ion Exchange using ion exchange resin. These resins are polymers that are capable of exchanging particular ions within the polymer with ions in a solution that is passed through them. Synthetic resins are usually used for water purification.
In water purification the aim is usually either to soften the water or to remove the mineral content all together. If the water needs to have the mineral content completely removed then it is passed through a resin containing H+ (which replaces all the cations) and then through a second resin containing OH- (which replaces all the anions). The H+ and OH- then react together to give more water.
It supplies PW at a rate of 1000liters/hour. The manufacturing company is Ion Exchange Ltd. (India).
The flow of PW through the Manual Purifier:
Figure: Flow chart for Manual Water Purifier
Description of flow process: The source of water is the underground water which is collected by using a deep tube well and then into an overhead reservoir. The water is filtered by passing it through a vessel filled with layers rocks of varying sizes. This is a gravel type filter. At the exit a Rotameter is placed to measure the flow rate of water. Then for the chemical process the water is passed through a set of three vessels, namely Cation Bed, Anion Bed and the Mixed Bed.
In the Cation Bed the resin used is 225H which adds to H+ content of the water by replacing all other cations. Thus the pH value decreases to 3.2 and so the water out of Cation bed is acidic.
As the water passes through Anion Bed it comes into contact with the resin FFIP, which adds OH- to the water, makes it basic and increased value of pH is within the range 7.5-9.8.
In the Mixed Bed, the mixing of these two types of water occurs and the final pH value drops down to the range of 5-7. The conductivity is ensured to be below 2μSiemens/cm. The PW is then collected in the Storage tank for PW.
The Cation and Anion Beds require regeneration after a certain time period of operation. HCl is used to regenerate Cation Bed and NaOH for Anion Bed. The regeneration takes 6-8 hours. During this time this plant doesn’t supply PW.
THE AUTOMATIC PLANT FOR PURIFIED WATER:Most of the modern water purifier utilizes the method of Reverse Osmosis combined with EDI cell. The Automatic Plant in RENATA Ltd. also falls in this category. Reverse osmosis, also known as hyper-filtration, is the finest filtration available today. Reverse osmosis will allow the removal of particles as small as individual ions. The pores in a reverse osmosis
Deep Tube Well Overhead Reservoir
Filter (Layers of rock of varying sizes)
Flow Meter (Rotameter)
ANION Bed (Synthetic Resin: FFIP)
CATION Bed (Synthetic Resin: 225H)
3.2pH water
7.5-9.8pH water
MIXED Bed Storage Tank for PW
5-7pH water
Conductivity <2
membrane are only approximately 0.0005 micron in size (bacteria are 0.2 to 1 micron & viruses are 0.02 to 0.4 microns).
The water flow rate is 1500Liter/hour.
The flow of PW through the Automatic Purifier:
Figure: Flow chart for Automatic Water Purifier
Description of flow process: The source remains same for both the plants, i.e., underground water collected into an overhead reservoir using a deep tube well. The subsequent steps are described below:
o Iron Remover: It helps to hold iron primarily. Silica and resin is used for this purpose. It cannot completely remove iron but restrains a considerable amount. This is necessary because Fe2+ iron is likely to form harmful fouls or scales later in the process.
o Reservoir: This reservoir collects the apparently iron free water.
RO (reverse osmosis) Membrane (Filter)
EDI Cell (removal of Pyroxene)
Storage Tank for PW
Deep Tube Well Overhead Reservoir
Iron Remover (Silica + Resin, holds iron primarily)
ReservoirBooster PumpFilter (Layers of rock of varying sizes)
Dosing System 1 (Sodium bisulphate, hardness removal)
Activated Carbon Filter-140
Softener 1 &2 (Brine solution, removes hardness)
Micron Filter Dosing System 3 (Silica Stabilizer)
Dosing System 2 (Caustic Soda, pH control)
Booster PumpRecirculation Tank
Heat Exchanger (to control temperature)
o Booster Pump 1: There are two booster pumps used in the automatic plant. From the flow chart is can be easily noticed that both the pumps are placed after reservoirs. The function is to smooth out the water pressure in case the flow is variable.
o Filter: This is also a gravel filter, one similar with that from the manual plant. It consists of a large vessel filled up with layers of rocks varying in size.
o Softner 1 & 2: The softening is done is two stages or in two vessels. Softening means removing the hardness of water, in chemical terms to remove cations like Ca2+ and Mg2+ etc. For this purpose Brine solution is used which is actually NaCl (Soduim Chloride) solution. The Brine Solution is added to the water at a controlled rate from separate tank.
o Activated Carbon Filter-140: It is used as a pre-treatment as part of a reverse osmosis system to reduce many organic contaminants, chlorine, and other items that could foul the Reverse Osmosis Membrane. Carbon filters are NOT generally successful at removing dissolved inorganic contaminants or metals. There are two principle mechanisms by which activated carbon removes contaminants from water; adsorption, and catalytic reduction, a process involving the attraction of negatively-charged contaminant ions to the positively-charged activated carbon. Organic compounds are removed by adsorption and residual disinfectants such as chlorine and chloramines are removed by catalytic reduction.
o Dosing System 1, 2 & 3: The chemical dosing is done in three stages. At each stage different chemical is dosed at fixed rate and the purpose is also different. At the first stage Sodium Bisulphate is added to remove the remaining hardness. Caustic Soda is added at the second stage and the purpose is to control the desired pH value. Finally Silica Stabilizer is used. It separates silica by coagulation method.
o Micron Filter: After chemical dosing is done water is passed through a micron filter. It filters micro organisms like bacteria or virus.
o Heat Exchanger: Then there is a heat exchanger to regulate the temperature of the water. It cools down the water to 21°C.
o Recirculation Tank: The water from the heat exchanger is collected in a recirculation tank. This is nothing but a simply reservoir.
o Booster Pump 2: The second booster pump then again directs water after smoothing the pressure to the RO Membrane.
o Reverse Osmosis Membrane (ROM): Reverse osmosis uses a membrane that is semi-permeable, allowing pure water to pass through it, while rejecting the contaminants that are too large to pass through the tiny pores in the membrane. Quality reverse osmosis systems use a process known as cross-flow to allow the membrane to continually clean itself. As some of the fluid passes through the membrane the rest continues downstream, sweeping the rejected contaminants away from the membrane and down the drain. The process of reverse osmosis requires a driving force
to push the fluid through the membrane. The booster pump upstream fulfills the purpose.
Figure: Working of a RO Membrane.
An RO membrane system can remove as much as 98–99% or more of all dissolved contaminants and can remove essentially all suspended (particulate) contaminants. However, RO units require pretreatment to prevent scaling, fouling with living and nonliving particulate materials, and chemical attack, commonly by oxidizing agents.
o EDI (Electrodeionization) Cell: EDI is a continuous electro-chemical process of water purification where ion specific membranes, mixed bed resin and a DC voltage across them, replace the standard acid-caustic chemical regeneration process. The EDI Cell consists of a series of thin chambers that alternately contain mixed bed resin for water purification and concentrate water flow to carry away impurities. Ion-specific membranes, cationic on one side and anionic on the other, separate the chambers.
A cationic-specific membrane will only allow positively charged ions to pass, while blocking the passage of negatively charged ions. An Anionic-specific membrane does just the reverse. Neither membrane will allow water to pass. High-voltage DC electrodes are located on the either side of the sandwiched resin/concentrate chambers.
As water begins to flow through the cell, the charged ions in the water in a resin chamber are captured by the ion exchange resin. When a voltage is applied across the cell, the captured cationic and anionic impurities begin to migrate across the resin bed in the direction of the appropriate electrode. The ions then pass through the ion-specific membranes into the concentrate chamber.
Figure: Schematic of an EDI Cell.
o Storage Tank: The water is finally collected in the common PW storage tank.
COMPARISON BETWEEN TWO WATER TREATMENT PLANTS:The points of difference between the two water plants are given below.
a) The manual plant occupies less space than the automatic oneb) The manual plant has lower initial and operating cost.c) Periodic and manual regeneration has to be done for the manual plant. At this time
the plant is out of order. But the automatic plant is self-regenerative. d) The efficiency and quantity of water supply is also comparable.
COMMON PURIFIED WATER DISTRIBUTION FOR BOTH PURIFIERS:The PW is then sent for distribution from the storage tank. Two pumps are used to maintain continuous circulation. Because pyrogen is likely to form in stagnant water. Pyrogen is a substance that produces fever. The PW is passed through UV sterilizer. The function of UV sterilizer is that it neuters the pyrogen but cannot remove it from the water.
DISTRIBUTION PATH FOR PURIFIED WATER:
Figure: Flow chart showing distribution path for Purified Water (PW)
Storage Tank for PW
User Points
UV Sterilizer (sterilizes pyrogen but cannot remove)
Two pumps (to maintain circulation)
WATER FOR INJECTION (WFI):PW contains dead bacteria which is undesirable for WFI. This dead bacteria or pyrogen is removed from PW by incorporating higher stages of purification.
The flow path of WFI:
Figure: Flow chart for WFI
Description of flow process: From the flow chart it is apparent that the higher purification employed for WFI is nothing but a combination of heat exchanger and condenser. The water is at first taken from the PW storage tank. Then water is passed through a multi-column (five columns) heat exchanger. The multi-column heat exchanger receives five utility inputs. These are feed water, cooling water, air, steam and electricity. There is a PLC control system present.
At this point the pyrogen gets separated from the water and drained. The remaining vapor is then cooled down again in the condenser. The condenser water is taken
Solids (pyroxene etc are collected and drained)
Pure Vapor
Multi Column Heat Exchanger
Storage Tank for PW
Cooling water (from external source)
Pressurized Steam (for ampoule cleaning)
Autoclave (for ampoule cleaning)
Jacketed pipes (to maintain 80°C)
Storage Tank for WFI
Condenser
User Points
Cooling water (from PW tank)
from two sources. One is from the PW storage tank and another source is external. The vapor and condenser water doesn’t come into direct contact.
As the water gets condensed, it is collected into a storage tank for WFI. The temperature is maintained at 80°C by passing it through jacketed pipes for distribution. At this temperature no pyrogen can survive.
Some application may require pressurized steam such as Autoclave for ampoule cleaning. In such cases steam is pressurized (up to 4.5 bar) locally near the user point by using Pure Steam Generator.
UTILITY: STEAM GENERATION PLANT
The steam generation utility is operated and maintained by the Engineering Department. The plant is on the service or utility floor.
APPLICATIONS OF STEAM IN PHARMACEUTICAL:
There are several functions which require the steam of certain pressure and temperature. These are:
o Water Treatment (to produce WFI, inside the multi-column heat exchanger)o Raw Material Dryingo Coating Machine for Tabletso Medicine Mixingo Washing Purposeo Sterilization (ampoule washing, autoclave) etc.
COMPONENTS OF STEAM GENERATION PLANT:
The equipments used are listed below:
o Boilerso Pure Steam Generatorso Pipelines
BOILER:
There are two boilers in RENATA Ltd. which maintain the required steam supply.
o Type of boilers:
Both water-tube and fire-tube boilers are used. But at the time of training the water-tube boiler was not operating.
o Fuels for boiler:
The fire-tube boiler running presently can utilize three types of fuels, i.e. natural gas, diesel and furnace oil. There is a diesel tank kept at a distance from the boiler so that diesel can be used without any delay when required. Usually diesel is used when the gas pressure is not sufficient. The use of furnace oil requires an additional heater.
No. of British Standard and Class of Construction: BS2790 1992 CLASS 1
o Specification of Boiler Burner:
Manufactured by: DUNPHY Combustion Ltd., ROCHDALE, England
Type: THD 310 YHLLFVD
Serial – 23005
Electrical specification: 400V/ 3phase/ 50Hz
Gas Type: Natural, I2H
Burner rating gas: 650-3050 KW
Oil type: Heavy oil
Burner motor rating: 6.6 KW
o Boiler Mountings:
Following is a list of boiler mountings:
Feed water pump: There are two pumps. One pumps runs alternately for seven days.
Water level indicator gage: It indicates the feed water input level. If the water level goes up a maximum level, it stops the pump.
Blower: The blower supplies air essential for combustion inside the boiler. Air supply in controlled by a damper. Purging time is 2-3 minutes. Purging means removal of exhaust gases remained from the previous operation period. The firing is done in two stages. At first low firing occurs. This procedure is ensured by a photocell sensor. Then the final firing occurs.
Safety valve: The working pressure of the boiler is 8-9 bars. The maximum pressure allowed is 10bars. But when the pressure reaches 9 bars, the safety valve opens automatically and the excessive pressure is released to ensure the safe operation of the boiler. It is situated at the top of the boiler.
Main valve: The main valve is also at the top. But its function is to supply the steam generated.
Chimney: The chimney is used for exhausting the flue gas. By analyzing the exhaust, it can be determined if any fuel is wasted or not. While running on diesel, if one notices smoke in the exhaust, then it can be assumed that fuel is not burned completely.
Pressure gages: There are several pressure gages. For example, the gas pressure gage, diesel pressure gage, exhaust pressure gage etc.
Blow down valve: As water evaporates inside the boiler, the metalic hardness of water remains within and is collected at the bottom of the boiler. It is necessary to remove it in order to prevent scale formation. Blow down is carried out by the operator manually. The blow down interval can range from 2-4 hours depending on the quality or amount of hardness present in the feed water.
o Boiler feed water treatment:
The feed water before entering the boiler is treated chemically to prevent scale formation. Scales reduce boiler’s efficiency as it hinders heat transfer. Dosing is done for this purpose. Typical dosing agents are Sodium Sulphide, Sodium Hydroxide, Hydrogen or Phosphate etc. The dosing is done in the dosing tank, which is full of resin inside. The dosing agent charges the resin which ultimately treats the water.
The feed water is available at ambient temperature. A little increase in temperature of feed water is desirable before entering the boiler. This increases boiler efficiency. So it is passed through a hot well. A portion of the steam from the boiler is used for this purpose.
o Boiler Inspection:
The boilers are inspected after every 1.5 years.
PURE STEAM GENERATOR:
Pure steam generator is used to increase the pressure of WFI steam generated. This highly pure steam is used in the autoclave for ampoule washing. There are two pure steam generators.
o Specification of PSG:
Manufactured by: DE LAMA, Italy
Electric voltage: 400 volts
Working pressure: 4.5 bars (psig)
DIFFERENCES BETWEEN BOILER AND PURE STEAM GENERATOR:
Pure steam generator differs from boiler in two respects. These are:
Boiler extracts heat from gas or flue gases, whereas pure steam generator extracts heat from steam from the boiler.
Raw water is feed into the boiler after chemical treatment. On the other hand WFI is the feed for pure steam generator. This is because the application requires steam free from any microbiological contaminants.
UTILITY: COMPRESSED AIR SUPPLY
Compressed air supply is an essential utility of pharmaceutical production procedure. Tablet press, capsule filling, dry sirup filling, coating, blistering all these processes require compressed air. The overall process of supplying compressed air in RENATA Ltd. is described below:
COMPONENTS OF COMPRESSED AIR SUPPLY PLANT:
Following is the list of equipments required to supply the desired quantity of dry and compressed air:
o Air Compressor: There are 4 compressors Specification of one compressor
KAESER KOMPRESSOREN GmbH, GERMANY
Serial no. ASD-37
Maximum working pressure: 11bar
Rated Power: 22KW
Speed: 2945/min
o Water Filterso Eco Drains
Specification of one eco drain:
KAESER Eco Drain 12
Made in Germany
0.8/16Bar (12/230 psig)
230VAC/50-60 Hz
o Air Receiver Tank: There are 2 Large tankso Dryer: There are 4 dryers
Specification of one dryer:
KAESER KOMPRESSOREN GmbH, GERMANY
Maximum working pressure: 18bar
Refrigerant: R-134a
Charge of refrigerant: 2.1 kg
Electrical specification: 400 V/3 phase/50 Hz
Rated Current: 4.3 Amp
o Header
FLOW PROCESS OF COMPRESSED AIR SUPPLY PLANT:
Figure: Flow chart for Compressed Air
DESCRIPTION OF THE FLOW PROCESS:
The compressor intakes air from ambient. But ambient air contains moisture which is undesirable for various purposes. At first the air-moisture is compressed together. Then the air is passed through a water filter, where the air-water separation occurs.
The separated water is passed through the eco drain. The purpose of the eco drain is to release the collected water without affecting the air pressure. It also thus restricts the outflow of air accompanied by water.
Eco drain consists of a coil-type water level sensor contained within a little container made of Gk-Al, electronic circuit, solenoid valve and diaphragm. The working principle is rather simple. The condensed water falls through the pipe into the container. As the container is filled up to a certain level, the sensor activates the solenoid valve. The water thus goes out as the valve opens.
The compressed air on the other hand is collected into a large receiver tank. This is done to ensure the constant flow at constant pressure. But the air is still hot. The temperature is 60-70°C. it needs to be cooled down.
Dryer is used to cool the air and to further reduce moisture. The dryer operates on typical refrigerant cycle. The refrigerant is R-134a. As the air further cools down the rest of the moisture gets condensed, collected and drained out manually.
Air Compressor
Water Filter
Eco Drain
Air Receiver Tank
Dryer
Water Filter Header for Distribution
Air
Air
Water
Water
Water
Then finally after passing again through a water filter, the air reaches the header. From the header the compressed and dry air is supplied through pipeline to the required stations.
QUALITY MAINTENANCE
Quality is a vital issue for a product. Quality of the product is maintained by the “Quality
Assurance” department in this industry. This department is divided into two parts:
Quality Compliance
Quality Control
QUALITY COMPLIANCE
Quality compliance means maintaining the consistency of the overall procedure. It ensures
that there will be no problem created in the production process by preventing all sorts of
causes of errors. It checks different parameters of the production process which have
already been set. For example, during mixing of ingredients the mixing proportion is
checked. Moreover the sequence of the production is maintained or not – that is also
checked. It also checks the physical parameters like – HVAC system, cleanliness, pressure,
temperature etc.
QUALITY CONTROL
Quality control means to maintain the quality of the raw materials, intermediate products
and finished products. It also ensures the proper chemical formulation and the quality of the
product. Quality control department works in different subgroups.
The subgroups are shown below:
Routine Commercial
Quality control checks the following properties of the raw material:
Appearance
Solubility
Moisture content
Impurity
Assay
Potency etc
These properties are checked according to the United State Pharmacopoeia (USP)
grade or British Pharmacopoeia (BP) grade. After checking all these things then the
raw materials are accepted.
In between the production process the checking is done also. After every process like
mixing, blending, granulating the quality of the intermediate products is checked. It
checks the uniformity of the product after every stage of production process. If the
standard deviation is less than three then the products are accepted.
Quality Control
Routine Commercial PD Development
Raw materialAnd
IntermediateProduct
Finished product
Packaging product
Source approval
Packaging material
check
Pilot batch finished product
Raw material of newly
developed product
This department also checks the following properties of the finished product:
Hardness
Thickness
Friability
Disintegration time
Volatility
Impurity etc.
Before packaging the packaging materials are checked. Packaging materials should
be not harmful for the product. The packaging should be of such that the air cannot
pass through it. Otherwise air can damage the desired properties of the product.
PD development
PD development means product development. This is also known as “Analytical
Team”. This department is concern about the development issue of the product. It
always tries to increase the quality of the product. In doing so this department may
change the source of the raw material. It may change the process of making the
medicine (USP or BP grade). But this is done only after proper analysis.
This department also checks the packaging material and to improve its quality it
takes necessary steps. It also searches for new product. For newly developed
products it analyzes the raw materials.
Stability of the product is also checked under the quality control department. It
determines the time period up to which the product will not lose its desired
properties. To do this extra temperature, pressure, humidity is applied to the
product for testing. A guideline is followed for that. It is “International Center for
Standard “.
There is a quality control lab equipped with modern machineries, tools and
instruments to check the quality of the product in different stages of the production
process. Every instrument is fully computer controlled. These machines show the
standard deviation automatically. Many pharmacist and chemist are work together
here.
QUALITY MANAGEMENT SYSTEM:
There is another group working in the quality department Known as “Quality Management
System” (QMS).They are responsible for
Market complain handling
Change control
Deviation Check
Corrective and preventive action (CAPA)
This department checks the demand of the market. It also faces the buyers. It also listens to
their complains. Then this department brings change in the quality control system to
improve the quality of the product according to the market demand. It finds out the
problems or wrong action in between the production process. Then if the standard
deviation is too much necessary preventive and corrective actions are taken. So the function
of this department is to take a market feedback.
The brochure team is working under QMS. Its function is the documentation of overall
process in details.
SACHET FILLING FACILITY (Mirpur, Dhaka)
Sachet Filling is a minor facility of RENATA Ltd. All products manufactured under this facility have the similar procedure. The HVAC requirements are same as the products from the general plant.
THE PRODUCTS:The Soft Gel facility manufactures mainly two types of products. The second product has three brands. These are as follows:
o Saline-Ro Vitamin and Minerals
Pustikona
Sprinkle
Monimix etc.
Fifteen ingredients are used for Pustikona. For Sprinkle and Monimix five ingredients are used.
MACHINES USED:Following is a list of machines used in Sachet Filling Facility:
o Vibratory Siftero Multi-Millo Blendero Filling Machineso Automatic Carton Machine etc.
PRODUCTION PROCESS:
The general flow process of products under Sachet Filling Facility from the Batch Manufacturing Record (BMR):
Released RM Store
(2-2)
Quarantine RM Store (2-
1)
Dispensing (3)
Mixing (4)
Filling (5)
Packing (6)
FG Store (7)
QC Check
Hold for decision
Accepted
Rejected
QC Check
Hold for decision
Accepted
RejectedQC Check
Hold for decision
Accepted
Rejected
Goods Receiving (1)
Figure: Overall Procedure including QC check and others of Sachet production
DESCRIPTION OF THE FLOW PROCESS:Description of the process of Sachet Filling product manufacturing is given below:
o Storage:
All the raw materials are stored in the store room. For saline raw material is sodium, sodium citrate, potassium, anhydrous, dextrose etc .For vitamin dry vitamin is the raw material. At first the raw materials are kept in the quarantine area for checking. Then sampling is done in a sampling booth. After that the raw materials are released for dispensing.
o Dispensing:
The purpose of dispensing booth is to release the correct amount of raw material. There is a weighing machine that can measure up to 60 kg. And for measuring the light weight there is another machine that can measure not more than 200 grams.
o Mixing:
After dispensing raw materials are shifted to blending room. Here the raw materials are mixed properly. At first the raw materials are placed into the Vibratory Sifter. Then these are shifted to Multi-Mill for crushing. Again these are moved to the Vibratory Sifter. Then the material is taken into Blender for proper mixing.
Figure: Flow process for mixing
There are separate blending room for saline and vitamin. Vibratory Sifter has 20 mesh for saline and 50 mesh for vitamin. Sieve diameter is one millimeter. For saline preparation mixing time is one hour. For vitamin it is 45 minutes.
o Filling:
Vibratory Sifter Multi-Mill
Blender
Process under controlled humidity and temp [40-60%]
Process under ambient humidity and temp [25°C ± 2°C]
After filling the products are ready for filling. Following is the list of machines used in the Soft Gel Facility for filling purpose:
GREATIDE:
There are three GREATIDE (model no. F, G, H) machines available at RENATA Ltd. Each machine is provided with manual photo electric control system. Each machine can produce 40 – 42 sachets per minute. But these machines are not being used due to lower productivity.
SOLPAC:
There are three SOLPAC (model no. J, K, L) machines available. Each machine is provided with PLC control system. These machines are used for filling vitamin & minerals. Each machine can produce 250 – 300 packets per minute.
The working process of these machines is given below:
Figure: Flow process in SOLPAC Machine
Figure: SOLPAC Machine
Foil
Slitting
Batch Print Horizontal Sealing at the bottom (2 heaters, 127°C)
Vertical Sealing at both sides (2 heaters, 127°C)
Powder
Cutting Upper Sealing
Foil comes from two ways for front portion and rear portion. Then the powder i.e. mixed ingredients pass through small conical shaped ducts which vibrates always. Vibratory motion helps powder to flow below. Then upper sealing and lower sealing are done by heating.
Upper sealing temperature is 127°C and the lower sealing temperature is 130 C. Then the batch number, manufacturing date and expired date are printed which is called batch print. After slitting and cutting the sachet filling is completed and the product is ready for packaging.
BOSSAR: PLC control
The number of BOSSAR (model no. A, B, C) machines available is three. Each machine is provided with PLC control system. These machines are used for filling saline. Each machine can produce 95 – 100 packets per minute. The working process of this machine differs from SOLPAC machine.
The working process of this machine is given below:
Figure: BOSSAR Machine
Bottom Sealing
Foil Side Sealing Side Cutting
Batch PrintEye Mark Sensor
CuttingPacket opening
Powder filling
Upper sealing
Foil is bended first to insert into the machine. Then lower sealing and side sealing are done. Sealing temperature is 140 C. Then the batch print is done. After that the packet is cut. There is a photo cell which actually a sensor to help cutting in right place. Then the sachet is opened for filling powder into it. After filling the powder upper sealing is done. And the product is ready for packaging.
o Leak test:
Leak test is done before packaging. It is done in the IPC room. Saline is tested by water and pustikona is tested by isopropyl alcohol.
o Packaging:
Packing system is not fully automatic. At first ten sachets are picked up manually by the workers. Then they put it into the automatic packing machine. This machine puts the 10 sachets into a packet made of paper. Then the packets are placed into a carton manually.
SOFT GEL FACILITY (Mirpur, Dhaka)
Soft Gel or Soft Gelatin is a minor facility of RENATA Ltd. considering not only the size of the plant but also the number of products manufactured under this facility. The products under this facility are intended for children.
THE PRODUCTS:
The Soft Gel facility manufactures three products. These are as follows:
o E-Gel-200o E-Gel-400o Lucent- 0.25mcg
The first two products are Vitamin E and the last one is Calcium (mineral).
MACHINES USED:
Following is the list of machines used in the Soft Gel Facility:
o Colloid MillGEq-193
o Medicine Service Tanko Vacuum Homogeneous Mixer
Sky Softgel, Co. LTD.
o Triple Rollero Gelatin Melting Tanko Softgel Encapsulation Machine and Tumbling Dryer
Made: SS-100
415 Volt, 50Hz, 4 Phase.
Serial: 5B0652F 77
Sky Softgel Co. LTD
PRODUCTION PROCESS:
The general flow process of products under Soft Gel Facility from the Batch Manufacturing Record (BMR):
Process under controlled humidity and temp [40-60%]
Process under ambient humidity and temp [15°C ± 2°C]
Labeling (2) Quarantine (3)Good Receiving (1)
QC Chec
k (4)
Stored for use (5)Dispensing (6) Hold for decision
Accepted Rejected
Medicine Preparation (7)
Gelatin Melting (8)
QC Chec
k (9)
Hold for decision
Rejected
QC Chec
k (15)
Hold for decision
Rejected
Transfer to FG Store (16)
Accepted
Encapsulation (10)
Drying (11)QC
Chec
k (12)
Hold for decision
Accepted
Rejected
Primary Packaging (13)
Secondary Packaging (14)
Accepted
Figure: Overall Procedure including QC check and others of Softgel production
DESCRIPTION OF THE FLOW PROCESS:The first six stages of manufacturing process are similar to any other products starting from good receiving to dispensing. The principal process is comprised of four stages. These are given below:
o Medicine preparation:
The medicine refers to the liquid within the shell or capsule of the product. In other words this is what is encapsulated. The process is mainly grinding and mixing carried out in a series of machines.
At first multi vitamin and multi mineral are taken into the Colloid Mill for grinding purpose. The mixed material is then taken into the Medicine Service Tank. After that, mixing is done in the Vacuum Homogeneous Mixer.
Finally the mixture is passed through a manual machine, the Triple Roller. In it all the processes mentioned above are carried out, namely, the grinding, colloid milling and final mixing.
o Gelatin Melting:
In this stage of the process the shell making is carried out. The process is nothing but just melting of gelatin occurs in a large drum or tank called Gelatin Service Tank. There are two tanks available for this purpose. As the melting takes place, the tank also rotates. There are electric motors provided for this purpose.
The process flow is shown below:
Figure: Flow Chart for Gelatin Melting
o Encapsulation and Drying:
The final stages are the encapsulation and drying. These are carried out in a single machine, Soft Gel Encapsulation Machine and Tumbling Dryer.
The medicine is added through a hopper which incorporates a pump. The medicine being liquid justifies the use of a pump. On the other hand gelatin is passed through a service pipe by creating a pressure difference. For this pupose pressurized air is used. The gelatin is also heated to soften it in order to facilitate the shell formation process. To ensure optimum softening it is passed over a cooling drum after heating. The gelatin sheet is then passed over a set of rollers. The rollers convey the gelatin sheet to pass over a drum on which there are impressed dies. At this point heated injection of medicine occurs and this pushes the gelatin to set inside the die, forming the shell.
Heat Generation Addition of Raw Material
Gelatin Service Tank
This machine is a symmetric one. In other words same process occurs from opposite direction on the same machine. This means two parts of the shell are made at the same time and seal immediately as injection of medicine occurs.
The Tumbling dryer is a blower. There are 8 vessels in it. The total drying is carried out for 40 minutes. The whole structure is made inclined so that the capsules come out of the machine automatically. If required the capsules are then again dried in a separate room using dryer.
The rest of the process is again similar to any other product manufactured in RENATA Ltd. The remaining stages include primary packaging in a blister machine, secondary packaging which is done manually in this facility, quality control and finally transfer to the finished goods store.
OTHER FACILITIES
ANIMAL HEALTH:
RENATA Limited is worldwide known for animal health products. They produce some highly quality products to serve animal health needs in the country as well as have some export ventures also in this project. The products are used in poultry farms and such other areas for hens, chickens, and cows mainly.
Animal Health products areo Tableto Capsule
The production is done inside the general plant facility, but in a special separate zone with required machineries and settlements.
Raw materials for Animal Health Products are purchased, stored and preserved totally separately than the other general products.
HORMONE:
Hormone Products are produced under three sections basically: o PPF-1.5(inside the general plant)o PPF-1(separate facility at the Mirpur site)o PPF-2 (under construction at the Rajendrapur site; also known as
Hormone-2) Hormonal products are produced under special safety precautions as they might be
detrimental to public health if inhaled or be openly in contact with regularly.GENERAL PLANT-2:
This project is under construction at the Rajendrapur, Gazipur site. This is even larger than the existing General Plant-1 facility. It is expected to start commercial production from the June-July, 2012.
CEPHALOSPORINE AND PENICILLIN:
The products under these facilities cannot be manufactured with others. The factory site in entirely at Rajendrapur site. Products are mainly antibiotics.
HERBAL PRODUCTS:
RENATA is supposed to start a herbal product plant very soon. Project is currently in the design phase.
ETP (EFFLUENT TREATMENT PLANT)
Industrial waste-water treatment covers the mechanisms and processes used to treat waters that have been contaminated in some way by anthropogenic industrial or commercial activities prior to its release into the environment or its re-use.
Most industries produce some wet waste although recent trends in the developed world have been to minimize such production or recycle such waste within the production process. However, many industries remain dependent on processes that produce wastewaters.
Effluent water: Contains mainly chemical contents, no micro organisms present. Equalization Tank: Water from production is collected for a certain time at a certain
rate, the time is known as Retention Time. It is required to obtain certain desired general parameters of the collected water as it comes from very different sources.
Here occurs aeration:
a) Naturalb) Compressed Air (Forced)
Advantages of aeration:
a) Mixing of waterb) Solidification of Ionized particles
Gravity settling: Solid particles fall as precipitates due to gravity. Coagulation Tank: Here Alum (Al2SO4) dosing is done. But beforehand the pH of
water is checked. If it is less than 8, then lime dosing is done. Flocculation Tank: Flocculation is a process where colloids come out of suspension in
the form of flakes. The action differs from precipitation in that, prior to flocculation, colloids are merely suspended in a liquid and not actually dissolved in a solution.
Tube Settler: Water is collected from the mid level, because upper level contains colloidal suspended particles and lower one is filled with heavy precipitates. The tubes are designed to maintain a laminar flow of water.
Activated Carbon: It purifies water by adsorbing different micro organisms. But at the same time it takes away some oxygen, which is detrimental to treatment process.
Final Treated water Tank: In this final tank, forced aeration is done to treat the water and compensate for the O2 loss in the activated carbon portion.
Drainage: Purified water is drained out to municipal drainage system, which eventually goes to the inland rivers.
INCINERATOR:
Incineration is a waste treatment process that involves the combustion of organic substances contained in waste materials.[1] Incineration and other high temperature waste treatment systems are described as "thermal treatment". Incineration of waste materials converts the waste into ash, flue gas, and heat. The ash is mostly formed by the inorganic constituents of the waste, and may take the form of solid lumps or particulates carried by the flue gas. The flue gases must be cleaned of gaseous and particulate pollutants before they are dispersed into the atmosphere. In some cases, the heat generated by incineration can be used to generate electric power.
Scum is collected to the sand bed filter. Then after drying by natural heating, the solid slug is taken to the incinerator. Here along with all the solid wastes, they are burnt at minimum 800˚C and released to atmosphere as CO2, no CO is present at that much high temperature.
To check if any industry is completely environment friendly or not, some parameters are to be measured of the water which is let out in the open environment. They are about 40 in numbers. Among them which are essentially important are:
BOD: Biological Oxygen DemandBiochemical oxygen demand or B.O.D. is the amount of dissolved oxygen needed by aerobic biological organisms in a body of water to break down organic material present in a given water sample at certain temperature over a specific time period. The term also refers to a chemical procedure for determining this amount. This is not a precise quantitative test, although it is widely used as an indication of the organic quality of water.[1] The BOD value is most commonly expressed in milligrams of oxygen consumed per litre of sample during 5 days of incubation at 20 °C and is often used as a robust surrogate of the degree of organic pollution of water.
COD: Chemical Oxygen DemandIn environmental chemistry, the chemical oxygen demand (COD) test is commonly used to indirectly measure the amount of organic compounds in water. Most applications of COD determine the amount of organic pollutants found in surface water (e.g. lakes and rivers), making COD a useful measure of water quality. It is expressed in milligrams per liter (mg/L), which indicates the mass of oxygen consumed per liter of solution. Older references may express the units as parts per million (ppm).
Many governments impose strict regulations regarding the maximum chemical oxygen demand allowed in wastewater before they can be returned to the environment. For example, in Switzerland, a maximum oxygen demand between 200 and 1000 mg/L must be reached before wastewater or industrial water can be returned to the environment
pH:In chemistry, pH is a measure of the acidity or basicity of an aqueous solution.[1] Pure water is said to be neutral, with a pH close to 7.0 at 25 °C (77 °F). Solutions with a pH less than 7 are said to be acidic and solutions with a pH greater than 7 are basic or alkaline. pH measurements are important in medicine, biology, chemistry, agriculture, forestry, food science, environmental science, oceanography, civil engineering and many other applications.
In a solution pH approximates but is not equal to p[H], the negative logarithm (base 10) of the molar concentration of dissolved hydronium ions (H3O+); a low pH indicates a high concentration of hydronium ions, while a high pH indicates a low concentration. This negative of the logarithm matches the number of places behind the decimal point, so, for example, 0.1 molar hydrochloric acid should be near pH 1
and 0.0001 molar HCl should be near pH 4 (the base 10 logarithms of 0.1 and 0.0001 being −1, and −4, respectively). Pure (de-ionized) water is neutral, and can be considered either a very weak acid or a very weak base, giving it a pH of 7 (at 25 °C (77 °F)), or 0.0000001 M H+.[2] The pH scale has no upper or lower limit and can therefore be lower than 0 or higher than 14 [3]For an aqueous solution to have a higher pH, a base must be dissolved in it, which binds away many of these rare hydrogen ions. Hydrogen ions in water can be written simply as H+ or as hydronium (H3O+) or higher species (e.g., H9O4
+) to account for solvation, but all describe the same entity. Most of the Earth's freshwater bodies surface are slightly acidic due to the abundance and absorption of carbon dioxide;[4] in fact, for millennia in the past, most fresh water bodies have long existed at a slightly acidic pH level.
DO: Dissolved OxygenOxygen saturation or dissolved oxygen (DO) is a relative measure of the amount of oxygen that is dissolved or carried in a given medium. It can be measured with a dissolved oxygen probe such as an oxygen sensor or an optode in liquid media, usually water.
It has particular significance in medicine and environmental science.
TDS: Total Dissolved SolidTotal Dissolved Solids (often abbreviated TDS) is a measure of the combined content of all inorganic and organic substances contained in a liquid in: molecular, ionized or micro-granular (colloidal sol) suspended form. Generally the operational definition is that the solids must be small enough to survive filtration through a sieve the size of two micrometer. Total dissolved solids are normally discussed only for freshwater systems, as salinity comprises some of the ions constituting the definition of TDS. The principal application of TDS is in the study of water quality for streams, rivers and lakes, although TDS is not generally considered a primary pollutant (e.g. it is not deemed to be associated with health effects) it is used as an indication of aesthetic characteristics of drinking water and as an aggregate indicator of the presence of a broad array of chemical contaminants.
Primary sources for TDS in receiving waters are agricultural and residential runoff, leaching of soil contamination and point source water pollution discharge from industrial or sewage treatment plants. The most common chemical constituents are calcium, phosphates, nitrates, sodium, potassium and chloride, which are found in nutrient runoff, general stormwater runoff and runoff from snowy climates where road de-icing salts are applied. The chemicals may be cations, anions, molecules or agglomerations on the order of one thousand or fewer molecules, so long as a soluble micro-granule is formed. More exotic and harmful elements of TDS are pesticides arising from surface runoff. Certain naturally occurring total dissolved solids arise from the weathering and dissolution of rocks and soils. The United States
has established a secondary water quality standard of 500 mg/l to provide for palatability of drinking water.
TSS: Total Suspended SolidTotal suspended solids is a water quality measurement usually abbreviated TSS. It is listed as a conventional pollutant in the U.S. Clean Water Act. This parameter was at one time called non-filterable residue (NFR), a term that refers to the identical measurement: the dry-weight of particles trapped by a filter, typically of a specified pore size. However, the term "non-filterable" suffered from an odd (for science) condition of usage: in some circles (Oceanography, for example) "filterable" meant the material retained on a filter, so non-filterable would be the water and particulates that passed through the filter. In other disciplines (Chemistry and Microbiology for examples) and dictionary definitions, "filterable" means just the opposite: the material passed by a filter, usually called "Total dissolved solids" or TDS. Thus in chemistry the non-filterable solids are the retained material called the residue.
CONCLUSION
The visit to such a well known factory for our industrial training was quite a lot beneficial to us in many respects. It was a well-equipped factory from which we could gather firsthand knowledge about mechanical engineering, how different machines work and their trouble shooting process, Practical issues over there, Staff management, labor control, Quality issues, co-operation of different departments, business dealing etc. The authority provided us with intense scope and facilities to learn so many different things in a very short time period. People over there were friendly and helpful. But, due to time constraints, we could not visit their under construction Rajendrapur Factory, where we could enhance our knowledge about the basic steps to start a factory, working procedure and project management etc. Yet, the industrial tour really taught us how to behave, manage and work properly in practical job life. Our sincere thanks and gratitude goes to each and every person who made this possible, both at RENATA Limited and Mechanical Department of Bangladesh University of Engineering and Technology.
