Often key factors which greatly impact the microbiological quality within a controlled environment remain undetected until a product, patient or other critical operation has been adversely affected. Microbiological sampling programs should be established to provide more than just a microbial recovery level for comparison to statutory requirements. If well designed, systematically collected, and clearly documented, a scientific interpretation of results by experienced contamination control personnel can allow the implementation of corrective actions which may prevent the adverse outcomes in product manufacture or patient care.
Monitronics air and surface microbiological testing capabilities cover all aspects of aerobacteriology. Surveys of manufacturing environments are individually designed through the development of Protocols incorporating applicable procedures presented within guidelines including: Current USP <1116>, <797> and <800>, current IEST-RP-CC0023, current ISO 14698 series, and Parenteral Drug Association Technical Reports. Monitronics instrumentation includes many microbial air samplers to allow selection of the best suited instrument for a given project. (slit impactors, sieve impactors, centrifugal samplers, filter samplers). Our service does not stop at the issuance of a report as the interpretation, statistical development of operational limits (alert & action limits) and design of proactive monitoring programs often prove of great service to our customers. Our goal is to truly become an extension of our customer’s internal quality assurance program. Experience in many diverse operational environments ensures the design of programs which meet regulatory, operational and business objectives.
Any service or support request is welcomed. We appreciate the opportunity to become an active team member of any project in which our specialties can be of service, no matter how large or small. Our experience in the design, operation, maintenance and certification of air handling systems ensure a unique perspective often unrepresented by traditional architectural and mechanical engineering project management.