Air Technology Division

Registered Office : Fullorhat, Ahutibagan, Near Fullorhat Yuba Sangha, Sonarpur, Kolkata - 700 150, W.B., India

Cell : +91 8335801001 | Landline : +91 33 2434 6692

Web : www.melius.in | e-mail : info@melius.in, meliusmail@gmail.com | Skype : rickbiswa

City Office : N2/52, 2nd floor, New Complex, S.S. Hogg Market, Nellie Sengupta Sarani, Kolkata – 700 087, W.B., India

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Total Range of Product / Activity

2 Stage /

3 Stage Filter

Single / Two Stage with

Authoatic Pulse Clean Filter

Single / Two Stage with Inertial Seperator, Cyclonic

Single / Two Stage Filter with

Roll-O-Matic Fiter / Auto

Clean Room / Clean Zone

System

Duplex Type automatic / Semi

Automatic Filter / strainer

Conical / Bag filter Static manual or

Auto Back

Hydraulic / Lube /

Fuel Oil filter With Housing

Moisture Separator,

Oil Separator, Collescing filter

For Pharma

Manufacturer

For Physical Laboratories

For Semi Conductor,

Wiper, Media, Electronic

Filtration System

Complete

Air Filtration System with

/ without Silencer

Water / Oil / Gas

Filtration

Clean Room / Clean Zone Equipments

Dispensing

/ sampling Booth

Safety

Cabinet

Laminar

Flow Bench

Globe

/ Pass Box

Air

Curtain

Validation

Fan Filter

Unit

Total List of Activity

Range of Product

/ Activity

Clean Room / Clean Zone

System

For Pharma

Manufacturer

For Physical Laboratories

For Semi Conductor,

Wafer, Media, Electronic Industries

Clean Room

/ Clean Zone

Equipments

Dispensing

/ sampling

Booth

Safety

Cabinet

Laminar

Flow

Bench

Globe / Pass Box

Air

Curtain

Validation

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20

9e Clean Room & Equipments Section

With each technological advancement, airborne molecular contamination (AMC) has evolved as a serious threat to

cleanroom environments. Contamination effects from AMC include corrosion on metal surfaces of wafers, wafer and optics

haze, unintentional doping and interference with packaging operations.

Under the revised USP Chapter 797 regulation, all compounding pharmacies are required to protect their products by utilizing a laminar flow workbench within a cleanroom. Greater care and

cleaner facilities are now required for Compounded Sterile Preparations (CSPs).

USP 797 refers to these ISO Global Cleanroom Standards; specifically the ISO 14644 series of standards. The current air cleanliness requirement for a Compounding Cleanroom is an ISO Class 8. A separate ISO Class 5

Device is required for the compounding of patient preparations. All sterile compounding is to be performed in an ISO Class 5 Device surrounded by an ISO Class 7 or ISO Class 8 Cleanroom Buffer Zone. “Risk Level ” determines

the required ISO cleanroom air cleanliness classification.

With over three decades of clean room design and installation experience, we're able to offer our clients a choice of services from site supervision to consultation, and conceptual design to full turn key construction, including

final certification. Technomart’s approach to a new project is flexible to meet the complete needs of our clients. We develop custom projects, often incorporating existing site conditions and using local, preferred contractors or

in-house labor for our engineering and construction efforts.

Melius’s wide range of capabilities allows us to design and construct a proven, practical and affordable cleanroom for any application. From ISO Class 1 to ISO Class 9 (FS209E Class 1 to Class

100,000), we design and build modular self-contained cleanrooms, softwall enclosures, prefabricated kits, as well as custom-built permanent facilities. We

provide Comprehensive Project Management from Start to Finish.

We provide comprehensive turnkey service, managing your cleanroom project from design through completion. We can support your needs after construction

with complete system maintenance. Our professional team works with you to determine your application's specific cleanroom needs, considering both your

immediate and long-term goals.

In addition, our vast experience in cleanroom system design enables us to identify and supply individual component needs. Other products and services include

Cleanroom Components, Separative Devices, and Cleanroom Testing and Certification. For extended project support, we offer a variety of maintenance

contracts specifically suited to meet the long-term requirements of your filtration application.

Offering a complete line of Hardwall and Softwall Clean Rooms to meet your exact size and Class requirements.

Cleanrooms, Products and Servicing acquired from Technomart will comply with the applicable standards

· ISO 14644-1: Cleanrooms and Associated Controlled Environments, Part 1: Classification of air cleanliness

· ISO 14644-2: Cleanrooms and Associated Controlled Environments, Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

· ISO 14644-4: Cleanrooms and Associated Controlled Environments, Part 4: Design, construction and start-up

· FS 209E: Airborne particulate cleanliness classes in cleanrooms and clean zones (withdrawn)

· EN 12469: 2000 Biotechnology - Performance criteria for microbiological safety cabinets

· cGMP Guidelines (good Manufacturing Practice)

· FDA (Food and Drugs Administration)

· GLP guidelines (Good Laboratory Practice)

Clean Room Standards and Classifications

ISO 14644-1 Clean Room Standards:

ISO Classification Number

Maximum concentration limits (particles/m³ of air) for particles equal to and larger than the considered sizes shown below

0.1 µm 0.2 µm 0.3 µm 0.5 µm 1 µm 5 µm ISO 1 10 2

ISO 2 100 24 10 4

ISO 3 1,000 237 102 35 8

ISO 4 10,000 2,370 1,020 352 83

ISO 5 100,000 23,700 10,020 3,520 832 29 ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 ISO 7 352,000 83,200 2,930 ISO 8 3,520,000 832,000 29,300 ISO 9 35,200,000 8,320,000 293,000

International Clean Room Class Comparison:

ISO Classification Number US FED 209E BS 5295 cGMP (operational)

ISO 1

ISO 2 ISO 3 M1.5 (1) 'C'

ISO 4 M2.5 (10) 'D' ISO 5 M3.5 (100) 'E' or 'F' A (B*) ISO 6 M4.5 (1,000) 'G' or 'H'

ISO 7 M5.5 (10,000) 'J' B (C*) ISO 8 M6.5 (100,000) 'K' C D

ISO 9 * at rest conditions

Melius has the expertise and experience to perform particle counting to a variety of cleanliness classes, as well as US and other classes. We can also offer design and use advice to fit your clean room to your requirements.

Air Handling Units

Laminar Flow Bench

Bio Safety Cabinet

Dispensing Booth

Sampling Booth

Pass Box ( Static & Dynamic )

Globe Box

Air Curtain

Standard followed :USP 797, ISO 14644, GLP, EN 12469, EU GGMP, cGMP, Schedule ‘M’, GMP, WHO GMP, US FDA, FS 209e

For Pharma ManufacturersFor Physical Laboratories

For Semi-Conductor, Wiper, Media, Electronic Industries

Clean Room / Clean Zone Systems and Equipments

From ISO Class 1 to ISO Class 9 (FS209E Class 1 to Class 100,000)We design and build modular self-contained cleanrooms, softwall enclosures,prefabricated kits, as well as custom-built permanent facilities.We provide Comprehensive Project Management from Start to Finish.

Clean Room Validation

A clean room or a clean space is defined as a room, a suite of rooms or an area of controlled environment. The concentration of airborne particulate matter in the area is strictly controlled, and other factors may be controlled within limits necessary to cater for the purpose of the controlled space.

The use of clean spaces for the manufacturing, packaging, laboratories and research has traditionally been the domain of the pharmaceutical, biotechnology, semiconductor, microelectronics and aerospace industries however application to other sectors is becoming more prevalent.

Hospital theatres utilise similar design and operation principals to clean rooms, however the objective with such facilities is to control particular types of contamination, rather than the quantities of particles present.

Typically a clean room will be specified by a classification from a certain standard. The classification relates to the definition of a maximum allowable number of particles of a range of sizes, related to a standard volumetric air sample size.

Clean rooms are grouped according to the type of activity performed and are thus:

Class 3.5 : Laminar flow clean rooms

Acute surgery areas Transplants Open heart Insertion of orthopaedic prosthesis Neuro-surgery Plastic surgery

Class 350 : Laminar flow clean rooms Major surgery and intensive care, Cytotoxic drug suites

Class 3500 : Non laminar flow clean room Minor surgery

Class 7000 : Clean room Pharmaceutical and therapeutic goods

Melius has the expertise and experience to perform particle counting to a variety of cleanliness classes, ranging from 0.035 to 7000, as well as US and other classes. We can also offer design and use advice to fit your clean room to your requirements.