Other Archives

Microbial Contamination Monitoring and cleanroom data management

Contamination Control Strategies for Innovation and Regulatory Compliance FAQ

Particle Measuring Systems (PMS) recently hosted a webinar titled Contamination Control Strategies for Innovation and Regulatory Compliance to explain how the implementation of a CCS attempts to address the varied causes of contamination and compromised sterility. This easy to read compendium for quick consultation consists of questions received in conjunction with the webinar along with questions from years of supporting our customers in their compliance journey. Questions are answered below by Ugo Omeronye .

Counting Efficiency and Comparison of Particle Counters

Some users believe it is necessary to divide the particle counts of non-volumetric particle counters by the counting efficiency (CE) at the lower limit to establish the “true” concentration of particles in the fluid system. Other users do not understand why two, similar-sized channels of particle counters with different limits of detection do not report the same value. This paper will discuss the science behind these differences and alleviate concerns that come from the characteristics of non-volumetric particle counters.

Contamination Control Strategies for Innovation and Regulatory Compliance

This paper addresses The 3 Steps of Developing a CCS: Assessment, Acceptance, and Remediation.
1. Assessment: Outline the CCS
2. Acceptance: Compilation of CCS Documentation
3. Remediation: CCS Evaluation

ATMP Environmental Monitoring

The primary importance of environmental monitoring for Advanced Therapeutic Medicinal Products (ATMP) facilities is to demonstrate the highest degree of control over
* The aseptic manufacturing environment
* The potential for cross contamination between batches / manipulations