Microbiology

Microbiology – Environmental Monitoring of a Cleanroom

SSE provides microbiology support, advice and training to clients involved in Cleanrooms and the Environmental Monitoring of a Cleanroom.

We are actively involved in analysing environmental report trending and finding the root cause of an issue where the microbial level of the controlled environment is exceeded.

SSE also provides support for start up companies that offers all necessary information available to ensure a smooth transition into the industry.

Providing Microbiology Support to our clients is a major advantage to SSE’s offering. Microbiology occurs at all levels within the Medical Device and Pharmaceutical Industries, therefore it is necessary to ensure support is available instantly on client request.

Microbiology support covers:

 
  • Knowledge of different testing methods (water testing, environmental testing)
  • Analysing environmental results
  • Providing support to clients if out of spec results are found
  • Major support to starting companies
  • Training

Why Microbiology support is necessary?

Microbiology is a major component of Medical Device and Pharmaceutical Industries. The environmental monitoring of a Cleanroom is performed on a regular basis and an element of the Monitoring is focused on the Microbial levels of different locations using different methods of testing.

Our service gives clients that extra reassurance and support to overcome any issues that might arise with Microbial results.

Here are just some reasons why Cleanroom Auditing is a necessity:

  • Issues that may arise within the Cleanroom
  • Experienced External Advice
  • Ensures a high standard of GMP is adhered to
  • Improving the standards of the Cleanroom and personnel awareness
  • Support corrective / preventive action process
  • Provide objective evidence through a written and photographic report
  • Prepares clients for Regulatory Body Audits such as FDA, IMB, ISO
  • Advise on changes in policies and procedures where necessary.

What is Audited?

  • Relevant Procedures.
  • Level of GMP within the Cleanroom & Supporting Areas.
  • Cleanliness & Housekeeping.
  • Personnel Behaviour.
  • Material Transfer Practices.
  • Overall effective Contamination Control Practices & Methods used.

Audit Reporting & Training

A detailed written and photographic Report outlining observations, suggestions and recommendations as to how the standard of GMP and policies and procedures can be improved will be submitted to the client.

Any suggestions or changes taken on board by the client can then be rolled out as part of a specific Training Programme delivered by SSE. Very often a Cleanroom Audit is performed in order to examine specific problems or issues within the Cleanroom Environment, for example, current Cleanroom Processes or Methods, Personable Behaviours and Environmental Monitoring Trends. All Training Programmes are delivered specific to the client’s requirements based on the results of the Cleanroom Audit.

A follow up Audit is performed after the Training has been complete in order to review improvements in Contamination Control Practices and to offer further guidance and support where required.