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 clean Room 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 clean Room. Greater care and cleaner facilities are now required for Compounded Sterile Preparations (CSPs).

USP 797 refers to these ISO Global Clean Room Standards; specifically the ISO 14644 series of standards. The current air cleanliness requirement for a Compounding Clean Room 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 Clean Room Buffer Zone. “Risk Level ” determines the required ISO clean Room 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.

Technomart’s wide range of capabilities allows us to design and construct a proven, practical and affordable clean Room 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 clean Rooms, 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 Clean Room 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 Clean Room needs, considering both your immediate and long-term goals.

In addition, our vast experience in clean Room system design enables us to identify and supply individual component needs. Other products and services include Clean Room Components, Separative Devices, and Clean Room 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.

 

 

 

 

Clean Room Standards and Classifications

 

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

 

  • ISO 14644-1: Clean Rooms and Associated Controlled Environments,
    Part 1: Classification of air cleanliness

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

  • ISO 14644-4: Clean Rooms and Associated Controlled Environments,
    Part 4: Design, construction and start-up

  • FS 209E: Airborne particulate cleanliness classes in clean Rooms 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 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