Viable and Nonviable Sampling

Viable Sampling

Microbial control plays a key role in all controlled environments. Microtest’s environmental sciences group can take a vital part in that control.

It’s difficult for workers in the controlled environments of medical device or pharmaceutical manufacturing, as well as in hospitals’ sterile compounding pharmacies, to maintain concentration on microbiological concerns. They usually lack significant training or experience in this science. Also, quantities of microbiological material that represent serious contamination are too small to see. Often, out of sight means out of mind.

So it’s a sad fact that controlled environments are most often contaminated by the people working in them.

For these and other reasons, ISO 14698 and USP Chapters <1116> and <797> require controlled environments to be regularly tested for the presence of microbial organisms.

The fully trained microbiologists of Microtest’s environmental sciences group can evaluate your controlled environments for contamination of aerobic and anaerobic microorganisms, including both bacterial and fungal (yeasts & molds) sources. We can perform surface testing and analysis via the RODAC or swab methods. We can also carry out active air sampling using state-of-the-art PBI samplers, and perform collection of passive air samples utilizing settling plates.

Time is of the essence when microbial control is found to be out of specification. If and when microbiological contamination does occur, our microbiologists can quickly identify the offending organism(s).

We utilize a MicroSeq DNA-sequence-based analyzer that provides a virtually 100 percent match in as little as 24 hours. Once the contaminant is identified, we provide the proper steps to isolate and eliminate the source, then get you back up and running in the shortest possible time.

Nonviable Air Particulate Sampling

Routine monitoring is critical to success when working in controlled environments. For air sampling of nonviable particulate matter, Microtest’s environmental sciences group uses only state-of-the-art equipment and the most precise sampling devices available.

We can test your controlled environments under ISO 14644 guidelines, the EU Annex, or both. Microtest uses advanced Met-One laser particle counters, as well as Biotest airborne particle counters with the capability to sample a full cubic meter of air in only 10 minutes. This equipment plus our extensive experience means our technicians can visit your facility and collect the appropriate number of samples for the size of your controlled environment without disturbing production.

Our specialists are fully trained to scan your processes and personnel for increased levels of particulate matter. If and when a nonviable air particulate spike is detected, our technicians will notify you immediately, then help track down the source with minimum downtime and maximum efficiency.

Clean room alert and action levels may be exceeded for a number of reasons; through the years, Microtest has encountered most of them. Our long experience can help provide a rapid resolution. We’ll quickly flush out the source of contamination and restore your process to full production.