Microbiological Environmental Monitoring
As aseptic processing (particularly in GMP facilities) relies on the prevention of microorganisms from entering products or test systems during testing or manufacturing, the microbial bioburden of the environment is vitally important.
It is important for manufacturers of pharmaceuticals and medical devices to understand the levels and identity of microorganisms in their environment in order to take proactive and effective means to reduce the likelihood of a contamination event in their products. They do this through establishment of a routine environmental monitoring (EVM) programme. Contamination events are not only potentially hazardous to the health of the patient using the product, but are also costly for the company involved in manufacture, in terms of possible product recall and brand image.
We assist with our clients’ environmental monitoring requirements by determining the level of background contamination using settle plates, contact plates and active air samples through on-site assessments, or by processing samples taken during client-own environmental monitoring schedules and procedures. We can establish the number of microorganisms present in the clients’ environment and can also identify the microorganisms present using our MALDI-ToF biotyper to identify accurately to species level. This allows the client to make informed decisions on any remedial steps they may need to take. Our experts at Wickham Laboratories have many years of experience in environmental monitoring and can assist in training, results interpretation and investigations by consultation.
Microbiological Monitoring of Cleanrooms
As part of our environmental monitoring, we offer a consultancy service to help with the set up and ongoing microbiological monitoring of cleanrooms in compliance with ISO 14644 and the Orange Guide, routinely assisting clients with:
- Risk assessment
- Routine Monitoring
We also supply industry standard triple wrapped irradiated environmental monitoring plates for client use and subsequent return to our labs for incubation, enumeration, and identification work.