Particle Measuring Systems (PMS) training

Our experts can train you at your site or organize events and company seminars. Basic training includes: Environmental and personnel monitoring. Cleanroom behavior and best practices. Cleaning and disinfection strategy. Good Distribution Practices (GDP). Microbiological laboratory best practices. Qualification vs. Monitoring.

Monitoring of nonviable and viable particles in a cleanroom is critical to meet regulatory requirements. An environmental monitoring system effectively collects, manages and reports on data from both types of sensors. Total particle contamination is a mixture of nonviable and viable particles. Historically, nonviable particles are monitored continuously while viable particles have been monitored on a less frequent basis. In modern aseptic manufacturing, both types should be monitored continuously to obtain an accurate indication of the cleanroom’s condition.

Chemical quality monitoring programs includes data gathered from the time chemicals are received all the way to the point of process. This may involve the use of grab samples and offline particle contamination monitoring to understand chemical quality. Establishing a well-controlled sampling protocol that does not contaminate the fluid and produce false positives is critical for successful grab sampling. Best known methods to minimize external contamination in the sample are presented to support data optimization. Customers are encouraged to incorporate these concepts in their own process development.

The best way to locate sources of contamination is via 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.

Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components. Absence of viable and non-viable contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product. Moreover, compressed gases can be viewed as critical utilities in pharmaceutical Industry when either in direct product contact or directly entered into the clean room environment.

On December 20th, 2017,  the draft for a Revision of ANNEX 1 (“Manufacture of Sterile Medicinal Products”) of the EU Guideline for GOOD MANUFACTURING PRACTICE for drug products and drug substances was published. This updated guidline will set a milestone for adjustments needed within European agencies overseeing drug products regulatory applications. During the creation process, the US FDA and PIC/S were consulted by and partnered with the EU on the proposal, showing the critical need to have standardized regulations reflecting the actual state of sterile pharmaceutical manufacturing. This on demand webinar provides a  summary of the new aspects of environmental monitoring in sterile manufacturing and its potential implications to the Pharmaceutical industry.

Download this On Demand webinar to learn about and compare various VBNC detection methods including: Direct counting methods, Dye reduction tests, Immunological-based methods, Genetic methods, ATP bioluminescence, Fluorescent labeling methods, Optical fluorescence.

ISO 21501-4 has two main goals; to improve instrument-to-instrument data correlation and count accuracy, and to enhance compliance with ISO 14644.

ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. After the recent release of the ISO 14644-1:2015 Revision Summary and Understanding ISO 21501-4 application notes, Particle Measuring Systems continues the ISO Standards interpretation series of documents with the evaluation of the newly released ISO 14644-2:2015.

The recently revised United States Pharmacopoeia (USP) chapter Microbial Control and Monitoring of Aseptic Processing Environments Chapteris arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on Contamination Recovery Rates (CRR) rather than the conventional enumeration of colony forming units (CFU).