Pharmaceutical Manufacturing Operations Investigation Services

In the pharmaceutical industry, product contamination poses a serious risk to manufacturing operations. If an out-of-specification event occurs, finding the root cause, taking remediation steps, and getting the manufacturing line back to full operational levels is critically important. Downtime on any manufacturing line can lead to a significant impact on the financial performance of the company.

Currently, the investigative tools and processes available to most pharmaceutical companies are slow, time consuming and often ineffective at shedding light on the source of contamination.

The IMD-A® 350 system is aptly designed for conducting investigations when out-of-specification findings occur. With the ability to detect inert and biologic aerosol particles simultaneously and in real time, the IMD-A system is an excellent assessment tool when conducting investigations. The instrument acts like an aerosol “sniffer” evaluating aseptic conditions in the impacted controlled environment, pointing investigators to possible causes so corrections can be made quickly.