Air Technology Division

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Air Technology Division AIR HANDLING UNITS FS 209E A IR V E NTI L ATI O N S Y E ST M Registered Office : Fullorhat, Ahutibagan, Near Fullorhat Yuba Sangha, Sonarpur, Kolkata - 700 150, W.B.

1 Air Technology Division AIR HANDLING UNITS FS 209E A IR V E NTI L ATI O N S Y E ST M Registered Office : Fullorhat, Ahutibagan, Near Fullorhat Yuba Sangha, Sonarpur, Kolkata , W.B., India Cell : / Landline : Web : info@melius.in, meliusmail@gmail.com Skype : rickbiswa City Office : N2/52, 2nd floor, New Complex, S.S. Hogg Market, Nellie Sengupta Sarani, Kolkata , W.B., India

Total List of Activity Total Range of Product / Activity Clean Room / Clean Zone System Clean Room / Clean Zone Equipments Validation Filtration System Complete For Pharma Manufacturer Dispensing /

2 Total List of Activity Total Range of Product / Activity Clean Room / Clean Zone System Clean Room / Clean Zone Equipments Validation Filtration System Complete For Pharma Manufacturer Dispensing / sampling Booth Air Filtration System with / without Silencer Water / Oil / Gas Filtration For Physical Laboratories Safety Cabinet 2 Stage / 3 Stage Filter Duplex Type automatic / Semi Automatic Filter / strainer For Semi Conductor, Wiper, Media, Electronic Laminar Flow Bench Single / Two Stage with Authoatic Pulse Clean Filter Conical / Bag filter Static manual or Auto Back Globe / Pass Box Single / Two Stage with Inertial Seperator, Cyclonic Hydraulic / Lube / Fuel Oil filter With Housing Air Curtain Single / Two Stage Filter with Roll-O-Matic Fiter / Auto Moisture Separator, Oil Separator, Collescing filter Fan Filter Unit

3 Standard followed : USP 797, ISO 14644, GLP, EN 12469, EU GGMP, cgmp, Schedule M, GMP, WHO GMP, US FDA, FS 209e Clean Room / Clean Zone System For Pharma Manufacturer For Physical Laboratories For Semi Conductor, Wiper, Media, Electronic Industries Range of Product / Activity Dispensing / sampling Booth Laminar Flow Bench Air Curtain Clean Room / Clean Zone Equipments Clean Room & Equipments Section Safety Cabinet Globe / Pass Box Fan Filter Unit Validation

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

5 Clean Room Standards and Classifications Cleanrooms, Products and Servicing acquired from Technomart will comply with the applicable standards ISO : Cleanrooms and Associated Controlled Environments, Part 1: Classification of air cleanliness ISO : Cleanrooms and Associated Controlled Environments, Part 2: Specifications for testing and monitoring to prove continued compliance with ISO ISO : 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) 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 ISO 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 ISO ISO 3 1, ISO 4 10,000 2,370 1, ISO 5 100,000 23,700 10,020 3, ISO 6 1,000, , ,000 35,200 8, ISO 7 352,000 83,200 2,930 ISO 8 3,520, ,000 29,300 ISO 9 35,200,000 8,320, ,000

Media, Electronic Industries Clean Room /

softwall enclosures, prefabricated kits,

to perform particle counting to a variety

6 For Pharma Manufacturers For Physical Laboratories For Semi-Conductor, Wiper, Media, Electronic Industries Clean Room / Clean Zone Systems and Equipments Standard followed : USP 797, ISO 14644, GLP, EN 12469, EU GGMP, cgmp, Schedule M, GMP, WHO GMP, US FDA, FS 209e 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. 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 Air Curtain Globe Box Pass Box ( Static & Dynamic )

The use of clean spaces for the manufacturing, packaging, laboratories and research has traditionally been the domain of the pharmaceutical, biotechnology, semiconductor, microelectronics and

7 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 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.

PARTICLE MEASUREMENT IN CLEAN ROOMS.

ENGLISH PARTICLE MEASUREMENT IN CLEAN ROOMS. PARTICLE MEASUREMENT Particle measurement in clean rooms. WP1508007-0100-EN, V1R0, 2015-08 PARTICLE MEASUREMENT IN CLEAN ROOMS. WHITEPAPER Content Content...