Industrial Training Presentation 1

8/3/2019 Industrial Training Presentation 1

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A Short Course on Lab Techniques &

Microbiology

Completed in:

Albert David Limited,

Ghaziabad


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CompanyProfile


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Albert David Ltd. is a part of the well-known Kolkata based

industrial house of Kotharis. It made a modest start in 1924 with a

single manufacturing facility.

Today its manufacturing capabilities extend to three manufacturing

units in Kolkata, Ghaziabad & Mandideep. The Ghaziabad &

Mandideep plants are WHO GMP & ISO 9002 certified and the

Kolkata plant is USA FDA approved


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TOC Analyzer monitors the level of totalorganic carbon content in the

water samples.

At various stages of time, the

different types of water used inthe processes are tested for theamount of total organic carboncontent in them.

It should be less than 500 ppb for

a sample of WFI (water forinjection)

The company uses TOC ModelSievers 900.


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UVVisible Spectrometry

Spectrometry refers to when aspectroscopic technique is used toassess the concentration or amountof a given species

Based on Beer-Lamberts law whichstates that Absorbance isproportional to both theconcentration of absorber andthickness of the layer

used in physical and analyticalchemistry for the identificationof

substances through the spectrumemitted from or absorbed by them.

The company uses Model UV 1700manufactured by Shimadzu Corp.


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Dissolution Rate Test Apparatus

The rate of dissolution is akey target for controllingthe duration of a drug's

effect DRT apparatus tests the

dissolution rate of themanufactured tablets as perIP/BP/USP standards

The company utilizesDRTO Model Disotest forthis dissolution testing oftablets.


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BOD Meter

chemical procedure for determininghow fast biological organisms use upoxygen in a body of water.

used in water quality management andassessment, ecology andenvironmental science.

This test is important to determine thelevel of contamination remaining inthe treated water sample before it is

released into the environment or usedfor other purposes.

The company uses BOD meter ModelOXITOP IS 6.


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The measurement is based on pressure measurement, which is

done by piezoelectric electronic pressure sensors.

The BOD readings are taken over 5 days and the highest and

the average values are calculated and monitored if they are

within acceptable limits.

BOD can be used as a gauge of the effectiveness of wastewatertreatment plants.


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Chemical Testing


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Chemical analysis involves testing of various samples for the

presence or absence of a particular component, and determining its

quantity, if needed.

Water is the primary and the most important raw material for any

pharmaceutical company and its purity and quality is of prime

importance for the formulation of drugs.

There are many types of water that may be utilized by the

company for its operations like:

Purified water

Water for injectionSoft water

Feed water

Blowdown water


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Various tests are performed according to the type of sample

used :

Purified & WFI :1. Chlorine tests

2. Sulphate tests

3. Oxydisable substance test

4. Conductivity tests

5. pH tests6. TOC (total organic carbon)

Soft water & feed water1. Hardness tests

2. pH tests Blow down water1. TDS

2. pH tests


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Test pH

Range

Conducti

vity

Range

(S)

Hardnes

s Range

(ppm)

Total

Dissolved

Solids

(TDS)Range

(ppm)

Total

Organic

Carbon

(TOC)Range

(ppb)

Water type

PurifiedWater

4.5

7 0

1.3 NA NA NA

Water for

Injection

4.5 7 < 5 NA NA < 500

Soft Water 7 7.5 NA < 5 NA NA

Feed Water 8 9 NA < 5 NA NA

Blowdown

Water

> 10 NA NA < 5000 NA


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Sample pHWater for Injection 6.0

Purified Water 5.5

Blowdown Water 10.0

Feed Water 7.5

Soft Water 7.0

pH Testing:

most basic test for any sample, pH of water sample is measured using universal

indicator, which gives a characteristic color according to the pH of the sample,

Requirements: Test tubes, Universal Indicator, pipette, water samples, test tube

rack, measuring cylinder.

Procedure:

All the test tubes were washed with distilled water to remove dust or any other

impurities.

The test tubes were washed with samples whose pH was to be measured.

10 ml of the samples were poured out into each of the tubes using a measuring

cylinder.

2-3 drops of Universal Indicator was added to each tube.

The resulting color was compared to a standard pH color chart.

Results:


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Sample Conductivity (S)Water for Injection 0.521

Purified Water 1.7

Conductivity:

Conductivity means the ability of any substance to conduct electricity across it. For

solutions, this electricity is in the form of movement of charged ions across its bulk.

Conductivity measures this movement and gives the result for conductivity. This test is

carried out mainly on Purified Water & Water for Injection.

Requirements: Conductivity meter, 25 ml beaker, measuring cylinder, water samples.

Procedure:

The beaker and the shell of the conductivity meter were washed with distilled water

The beaker and the shell were again washed with water sample

25 ml of the sample was poured out into the beaker using a measuring cylinder, so that

the shell of the conductivity meter was dipped fully into the solution.

The meter was switched on and the readings recorded.

Results:


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Total Dissolved Solids (TDS):

Total Dissolved Solids test checks for the total amount of solid impurities present

in the water sample. This test is carried out mainly for Blowdown Water.

Requirements: Conductivity meter, test tube, water sample, measuring cylinder.

Procedure:

The conductivity of the water sample (Blowdown Water) was determined by theprocedure given earlier.

The TDS value (ppm) of the sample is calculated by the following relation:

TDS (ppm) = [Conductivity (S)] * 500

where 500 represents the constant factor in case of Blowdown Water.

Result:

The TDS value of the water sample was 3760 ppm.


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Sample Hardness (ppm)

Soft Water 3.6

Feed Water 3.6

Hardness:

Hardness is caused by the insoluble salts of magnesium and calciumin the water

sample. The hardness test is mainly carried out on Soft Water and Feed Water.

Procedure:

250ml + 2ml + 2-4 drops of + Titrate by 0.02NSample ammonia buffer Eriochrome EDTA

solution Black-T indicator

Purple to Blue

The hardness value was calculated as follows:

Hardness (ppm) = [vol. of EDTA used (ml)] * 4where the multiplication factor of 4 gives the value of hardness for 1 liter of the

solution.

Result:


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Chloride Test:

This test determines the level of chloride content in the water sample. This test is

mainly carried out on Water for Injection (WFI) and Purified Water. The aim is toprecipitate the chloride ions present in the sample as silver chloride (AgCl),

which forms a white, insoluble precipitate.

Procedure:

10 ml of + 1 ml + 0.2 mlwater sample 2M HNO

30.1M AgNO

3

appearance remains unchanged(atleast 15 minutes)

Result:

No chloride content was found in any of the samples tested.


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Oxidizable Substances:

This test is used to estimate the amount of oxidizable substances present in any

given sample. This test is mainly carried out on Purified Water and WFI.

Procedure:

100 ml + 10 ml + 0.1 mlSample 1M H2SO4 0.02M KMnO4

(boil for 5 minutes)

Solution remain faintly pink.

Result:

No oxidizable substances were found in any of the samples tested.


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Sulphate Test:

This test is carried out mainly on Purified Water and WFI. It checks for the

total sulphate content in the water sample.

Procedure:

10 ml + 0.1 ml + 0.1mlsample 2M HCl BaCl2

appearance remained unchanged

( at least 1 hour)

Result:

No sulphate content was found in any of the samples tested.


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Microbiology Testing


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Microbial environment monitoring is done to check thebioburden of aseptic area of controlled environment.

Purpose is to understand the issues related to establishment,

control & maintenance of aseptic conditions in a controlledenvironment.

Samples are collected by exposure of media plates to theenvironment at specific points. The plates are then incubated

and examined for microbial growth

Alert limits for class 10,000 & class 1,00,000 environments are25 cfu/plate & 10 cfu/plate respectively

Environmental Monitoring


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Environmental Monitoring

In the settle-plate technique, plates are prepared usingSoybean Casein Digest Agar (SCDA) medium forbacterial & Soybean Digest Agar (SDA) medium forfungal analysis. These plates are exposed at specificpoints in the sterile area for 30 mins & incubatedseparately (20 - 25 C/ 5 days SDA; 30 -35C / 3 daysSCDA) & examined after the mentioned period.


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Bacterial Endotoxin Test

This test detects the presence of endotoxins (pyrogens)present in human injectible drugs & medical devices.

Endotoxins are normally harmless, except if injected

directly into the bloodstream.

The test is done using Limulus Amoebocyte Lysate(LAL) from the blood of the horseshoe crab.

LAL becomes turbid & forms a gel clot in the presenceof endotoxin. The higher the endotoxin level, the fasterthe gel clot will be formed.


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The test is carried outwith positive & negativecontrols. Positive controluses 50l each ofendotoxin & WFI and 100ml of lysate. Negativecontrol uses 50 l each ofLRW & WFI and 100 mlof lysate.

The samples as well asthe controls areincubated at 37C for 1 hr.& analyzed.


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The left plate shows thepositive results for thetest, while the right one

is negative.

The main limitation ofthis test is that it detects

pyrogens from onlyGram-negative bacteria


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Sterility Test

This is an After Sterilization (AS) test carried out on thefinished products.

This test is used to detect the presence of viable formsof bacteria, fungi & yeast in / on the preparation.

The test is done under conditions designed to avoidaccidental contamination of the product during testing.

Fluid Thioglycollate Medium (FTGM) is used forculture of bacteria while Soybean Casein DigestMedium (SCDM) is used for the culture of bothbacteria & fungi.


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Sterility Test

The sample to be tested isaseptically filtered using amembrane with a pore size 0.45m. This membrane is

then cut into 2 pieces, andincubated in 100 ml each ofFTGM (20-25 C/14 days) &SCDM (30 -35 C/14 days)

respectively.


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Sterility Test

After the incubation, thetubes or samples areanalyzed. Presence of anybacterial / fungal

contamination in theproduct is indicated byappearance of turbidityin the respectivemedium.

In case of positive tests,the organism is isolated& identified & theproduct rejected.


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Industrial Training Presentation 1

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