Environmental Monitoring – Viable and Non-Viable Testing

Environmental Monitoring is a critical process utilized to assess cleanrooms and other controlled environments within the pharmaceutical and biotechnology industries. It serves as an important pro-active tool for Quality Assurance programs in the manufacture and control of sterile and non-sterile products and support areas.

Micro-Clean Certification Services adheres to environmental testing guidelines for static and dynamic testing, according to FS 209E, ISO 14644-1, USP, EU and Sept. 2004 FDA guideline on sterile drug products produced by aseptic processing. This is accomplished by using the most advanced equipment such as BIOTEST RCS, RCS Plus Air Samplers, RODAC plates, BBL swabs and Laser Particle Counters.

Our Environmental Monitoring Specialists not only execute testing but also report your results using thorough yet concise data formats. The samples collected are delivered to Focus Laboratories (http://www.focus-lab.com), our affiliate in-house (located within our facility) microbiology laboratory/ consulting service for analysis. Together, we create synergy that enables our customers to obtain rapid results to identify any current or potential contamination. Clients also benefit from rapid processing of samples, delivery of reports and convenient access to professional microbiological expertise.