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Related Experiment Video

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Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Microbial validation of vent filters.

J H Robertson¹, W R Frieben

¹The Upjohn Company, Kalamazoo, Michigan 49001.

Biotechnology and Bioengineering

|August 1, 1984

Summary

This summary is machine-generated.

Filtration systems effectively remove microorganisms from gases used with sterile products. Testing confirmed hydrophobic filters retain at least 10(9) Bacillus subtilis spores, ensuring product safety.

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Determining Viral Disinfection Efficacy of Hot Water Laundering

Determining Viral Disinfection Efficacy of Hot Water Laundering

Published on: June 21, 2022

Area of Science:

Microbiology
Filtration Technology
Pharmaceutical Manufacturing

Background:

Sterile products require protection from microbial contamination.
Filtration is a key method for removing microorganisms from gases.
Validating microbial retentivity of filters is crucial for product safety.

Purpose of the Study:

To validate the microbial retentivity of filters used for sterile products.
To simulate real-world conditions using an aerosol challenge.
To assess the performance of hydrophobic filters against Bacillus subtilis spores.

Main Methods:

Developed a test apparatus with autoclavable components, a jet-type nebulizer, and a heated air mixing tube.
Characterized Bacillus subtilis var niger spore aerosol particle size distribution (80% < 3.0 µm, mean mass diameter 1.9 µm).
Challenged hydrophobic filters with aerosols containing at least 10(8) Bacillus subtilis spores.

Main Results:

The test apparatus recovered approximately 50% of aerosolized Bacillus subtilis spores.
All tested hydrophobic filters demonstrated the ability to retain at least 10(9) spores.
Filter integrity was verified post-challenge.

Conclusions:

The developed aerosol challenge method effectively simulates filter use for sterile product applications.
Hydrophobic filters exhibit high microbial retentivity, capable of retaining significant quantities of Bacillus subtilis spores.
The validated filtration process ensures the integrity and safety of sterile products by preventing microbial contamination.