info@pmeasuring.com

Knowledge Category: Other

Compressed Gas monitoring
Compressed Gas Monitoring: An Important Component of an Environmental Monitoring Program

A large proportion of products labeled as sterile are manufactured by aseptic processing rather than terminal sterilization. Because aseptic processing relies on the exclusion of microorganisms from the process stream and the prevention of microorganisms from entering open containers during processing, product bioburden as well as the bioburden of the manufacturing environment are important factors governing the risk of unacceptable microbial contamination.
airborne particle counter New Lasair Pro
ISO 14644-1:2015 Revisions Summary for Electronics

The recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper will highlight the major changes in the new ISO 14644-1 compared to the previous version and the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.

Over the last five years, the ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness classification, 14644-1 and -2.
HCT/P Environmental Monitoring
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 1271—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.