Effective Risk Assessment in Pharmaceutical

Steps to Ensuring a Successful Audit

A risk assessment for pharmaceuticals is the first critical step when designing a contamination control for aseptic manufacturing. Product quality is the critical measure of success.

To ensure product quality, it is imperative that effective particle counting and microbial monitoring is set up for contamination control. The best way to locate sources of viable non viable contamination in your aseptic manufacturing is via a risk assessment, best performed before a process has been implemented.

There are multiple tools to assist in completing a risk assessment, and once completed, it is imperative to continually update this body of knowledge to guarantee a defensible monitoring program is developed and enacted.


Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:

  • Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
  • PMS Cleanroom particle counters including portable/mobile and fixed/remote
  • Microbial Monitors including portable/mobilefixed/remote, and single use.
  • Data management software from Particle Measuring Systems

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.

Ensuring successful audit