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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 : [email protected], [email protected] | 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
Fan Filter
Unit
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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.