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Knowledge Category: Other

Cleanroom Classification
Cleanroom Classification for
Pharmaceutical Applications

Pharmaceutical products are manufactured to meet exacting standards of both efficacy and quality. All aspects of quality are reviewed considering the risks associated with the delivery method (injected, ingested etc.) and the manner in which they were produced (aseptic, terminally sterilized, or under lesser controlled conditions). This paper looks at two parts of that process: the quality of the environment in which the product is manufactured and the standards that surround the particle concentration limits that determine what a controlled environment consists of.
Risk Assessments
Risk Assessments as a Process Quality Assurance Tool

Environmental contamination control is a critical component of sterile pharmaceutical manufacturing, and Risk Management is necessary to ensure that the correct control practices are in place. The Risk Management process is a series of steps, including risk assessment, that allows for a deeper understanding of the manufacturing environment. Removing, reducing, or monitoring activities associated with a product or process to mitigate risk may be the result of such an assessment. This qualitative risk assessment can be transformed into a quantitative evaluation using modern risk analysis tools and procedures; these tools deliver the fully documented rationale behind the path chosen.
ISO 14698
A Review of EN ISO 17141, ISO 14698 andInstrumentation Conformance

In August 2020 the normative standard for Europe EN 17141, Cleanrooms and associated controlled environments – Biocontamination control, was issued. It essentially replaces the existing European Standards (EN) ISO 14698-1:2003 and (EN) ISO 14698-2:2003 within the European Standards community countries, and is associated with the cleanroom standard ISO 14644-1:2015, Cleanrooms and associated controlled environments – Part 1 Classification of air cleanliness by particle concentration. Globally, ISO 14698 –1&2:2003 are still valid and applicable.
Aerosol Particle Counter Matching
A Practical Guide to Aerosol Particle Counter Matching

A common question related to aerosol particle counters is how well particle counting results should match each other. New airborne particle counters added to an existing fleet won’t always match the counts of the old. This could be as a result of different manufacturer’s, but even when the particle counters are supplied by the same manufacturer, it is not uncommon for variation to exist. In this short paper, we provide a practical guide for the expectations one should have when comparing particle count data from similar and dissimilar instruments.