Controlled Environment Testing
Cleanroom systems International is leading environmental testing laboratory since 1993. We are IANZ accredited test laboratory in field of applied science and highly specialised in testing , validation and monitoring of cleanrooms as well as containment facilities to latest national and international standards like ISO14644, PIC/s , AS/NZ 1807 . We have most experienced and qualified staff, who are well versed with various industries and their cGMP requirements.
As a test laboratory, we have well developed standard protocol and specifications for testing of Cleanrooms, Operating Theatres, Containment facility, Laminar flow cabinets, Bio safety cabinets, Fume Cabinets, Spray Booths , Microbial testing in cleanrooms and Compressed air .
We have established tests and certification routine, which we performed annually or six monthly based on the industries and standard requirements.
For your requirement or any information Enquire now .
Cleanroom tests and procedures may vary considerably from project to project. The choice of certification tests may be based on the cleanliness class level, type of cleanroom airflow, occupancy mode and the product produced. The scope of the cleanroom testing services may vary based on the agreed scope of services between the Customer and CSI ltd .
For recommended tests for initial cleanroom certification please contact us . If you are already our customer , and the cleanroom has been tested then login to
to your accounts for the test booking or alternatively send us an email.
Operating Theatre , Sterile Store or Isolation suite , all ventilation systems are designated as critical HTM03-01 . The testing specifications are based on various guidelines including draft Ventilation Guidelines Operating Theatres, by Ministry of Health, Wellington , UK HTM03-01 and section 5 of AS 1668.2-2012.
Based on design guidelines, purpose of rooms and testing requirement, operating theatres are classified as ultra clean , ISO Class 5, ISO Class 7 , ISO Class 8 and Sterile Setup .
Laminar flow cabinet OR Clean work station provides a controlled environment for protection of product from contamination but does not provide personnel or environment protection. It is self-contained fan,HEPA filter system , which create clean zone by supplying uniform filtered airflow in the workzone.
Clean work station are tested to AS2252.6-2011 standard.
The Class II vertical laminar-flow biological cabinet is an open-front, ventilated cabinet. This cabinet provides a HEPA-filtered, recirculated mass airflow within the work space. The exhaust air from the cabinet is also filtered by HEPA filters. Thus, the Class II biosafety cabinet will provide personnel, environment and product protection.
Class II cabinets may be tested to one of the following- the Australian Standard (AS2252.2) or
by NSF49 Field Test Methods, or EN 12469.
A Fume cupboard should be compared and tested according to AS2243.8 and reported accordingly.
Fume cupboard are tested for Face velocity, smoke Test, Sound Level and Lighting .
We also carry out 6 monthly and annual maintenance inspection as per AS2243.8 requirement. If needed we can also conduct Installation inspection.
The FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing cGMP states: A compressed gas should be of appropriate purity (e.g., free from oil) and its microbiological and particle quality after filtration should be equal to or better than that of the air in the environment into which the gas is introduced.
Compressed air system is tested for four parameters as per ISO 8573-1:2010 Air purity , Moisture , oil content and as per customer requirement Microbial count .