Microbiology.com

  Bioburden OR Microbial load testing (MLT) is a regulatory requirement and is critical for process development of biological, pharmaceutical, surgical, and dental and other medical devices i.e., catheters and stents along with systems. It is an important test for raw material, semi-finished and finished product. It can provide an accurate basis for calculating effective sterilization doses and will provide the quantity of viable microorganisms in or on product or raw material before sterilization. Bioburden testing is applicable for: Lot Release Testing Final Product Testing Raw Material Testing Semi-finished Product Testing Contact us  about your bioburden testing needs. Microbiology.com can provide all these services in accordance with ISO 11737, USP <61>, USP <62>.

      Biological Indicators (BIs) are widely used to monitor the efficacy of sterilization processes. BIs provide a high level of sterility assurance and are ideal monitors of the sterilization process. The BI Sterility test is performed on exposed BIs after completion of a sterilization load through either a validation or routine lot release monitoring. The test is qualitative which yields results of either growth or no growth of the appropriate indicator organism. The test is performed on BIs subjected to different types of sterilization such as ethylene oxide, steam, dry heat, vapor phase hydrogen peroxide and ozone, as well as other novel processes. Both traditional BIs and self-contained BIs may be tested. This test is typically performed during validation as well as during routine production as a LOT release test. BI testing and sample requirements are in numerous standards including USP <55>, the ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 14161, and ANSI/AMMI/ISO 11138 s

  TESTING PART 1 DEMONSTARTION OF CONTINEOUS COMPLIANCE FOR CLEAN ROOMS   PHYSICAL ENVIRONMENTAL MONITORING 1.   Physical Testing (General) Compliance with air cleanliness (ISO Classes) requirements specified by the ISO14644 is verified by performing specified testing procedure and by providing specified documentation of the result and conditions of testing, as agreed upon by client and service supplier (the third party) and internal testing labs.   The reference test method for demonstration of compliance is as per ISO-14644-1, ISO 14644-2 & ISO 14644-3. An alternative method having comparable accuracy may be specified, although if no method is specified or agreed upon, the reference method shall be used. For Clean rooms, clean zones & clean air devices existing at any company, following physical tests are included for demonstration of compliance. 1.1.      Airborne particle count This test is performed to determine air cleanliness class (classification test

  Clean Room in Microbiology Testing Lab A cleanroom is a core component in microbiology. A laboratory, in which almost every microbiological activity is carried out, is vulnerable to exposure to unwanted particles, these particles carry viable particles as well. The penetration of these particles into the test can manipulate the results of a test or an experiment. Thus, it is important to ensure that the laboratory is clean, in other words, the required environment in which these contaminants are controlled so that they are in accordance with the specifications of the laboratory. This is what a cleanroom is in microbiology. A cleanroom is a laboratory or any location where the nature, size and number of permitted particles are checked so that they do not become contaminants that stand in the way of the test. Before conducting any microbiological testing, it is an important first step to control the lab environment. Detail written procedure must be implemented to enter and exit l