Archives: Papers

ISO 14698
ISO 17141 v. ISO 14698
& Instrument Conformance

In August 2020 the normative standard for Europe EN 17141, Cleanrooms and associated controlled environments ā€“ 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 ā€“ Part 1 Classification of air cleanliness by particle concentration. Globally, ISO 14698 ā€“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.
HCT/P Environmental Monitoring featured image
Human Cell, Tissue, And Cellular And Tissue-Based Products (Hct/P) Environmental Monitoring Requirements: 21 CFR 1271

The Food and Drug Administration (FDA) requires human cell, tissue, and cellular and tissue-based product establishments to follow the current Good Tissue Practice (GTP), which governs the methods used in, and the facilities and controls used for, the manufacture of human tissue and cellular and tissue-based products. The
following regulation is to be enforced as of May 25, 2005: 21 CFR 1271ā€”Human Cells, Tissues, and Cellular and Tissue-Based Products 21 CFR 1271.195 Environmental control and monitoring Section 1271 requires facilities to establish and maintain procedures to adequately control and monitor environmental conditions and to provide proper conditions for operations. The regulations were created to improve protection of the public health. Section 1271.195 specifies the monitoring parameters required.Ā 
Particle Contamination in High-Purity Process Chemicals
Filtered Seawater Particle Counts for Injection into Oil Reserves

Seawater injection is a secondary recovery technique used in oil reservoirs to replace extracted oil and maintain well pressure. Oil reservoirs are typically found within the small pores of sedimentary rock formations, so it is imperative that the injected seawater does not contain suspended particle matter that can clog these pores and hinder oil recovery. Since untreated seawater contains significant quantities of suspended particle matter it is generally filtered prior to injection into oil reservoirs. Optical particle counters offer an accurate and reliable solution to quantify particle concentrations in filtered seawater used for injection.

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