Environmental monitoring encompasses a range of test methods to identify and understand the microbial environment that exists within any given manufacturing process. SMTL provide an extensive environmental monitoring programme encompassing both physical measurements (airborne particulate concentration and air flows) and microbiological monitoring (active air and surface monitoring) to ensure continued compliance with any required standards.
A routine environmental monitoring programme enables manufacturers of pharmaceuticals and medical devices to understand the baseline particulate levels and identity of microorganisms in their environment. From this baseline, alert and action limits can be established to effectively monitor and reduce the likelihood of contamination events.
SMTL hold UKAS accreditation for the testing of controlled clean rooms and can offer on-site classification of clean rooms to national and international standards as well as current guidance to good manufacturing practice (GMP). All tests are performed by our Quality Assurance department with trained, responsible, competent and flexible staff working to documented test procedures to meet environmental legislation. Examples of our routine testing include:
Our experts provide consultancy for all your cleanroom requirements. From unexpected results and assistance with documentation, to guidance with room designs and workflows, we work with our clients to achieve the highest standards attainable.
In addition to our on-site testing, we can supply industry standard triple wrapped irradiated environmental monitoring plates for client use, and subsequent return to our labs for incubation, enumeration, and identification work.