ABSTRACT

This Technical Briefing provides information about sterilising grade filters utilised for the filtration of liquids and gases for pharmaceutical and biopharmaceutical applications.

Information includes details relating to the filtration mechanisms, filter ratings, filter validation and in-process testing of filter integrity…..

KEYWORDS: Adsorption, Air and Gas Filtration, American Society for Testing and Materials (ASTM) F838-15a, ASTM F838-15a. Standard Test Method For Determining Bacterial Retention Of Membrane Filters, Autoclaves, Bacterial Challenge Test, Bioburden, Biopharmaceutical, Brownian Movement, Bubble Point Test, Compressed Gases, Diffusion, Diffusion Test, Disinfectants, Electrostatic Attraction, Filter Integrity Testing, Filter Validation, Filtration, Fluid Steam, Gas, Heat Labile Solutions, Hydrophobic (PTFE), Inertial Impaction, Interception, Liquid Filtration, Maximum Diffusional Flow, Medicinal Drug Processing, Microbe Carrying Particles (MCPs), Microbes, Microbial Contamination, Most Penetrating Particle, Particle Removal, Particle Retention Mechanisms, pH, Pharmaceutical, Size Exclusion, Sterilising Grade Filter Rating, Sterilising-grade Filters, Storage Tanks, Terminally Sterilised, Testing, Triboelectric Effect, Van Der Waals Forces, Vent filters, Water Intrusion Test (WIT), Water Systems.

More detailed information and explanation regarding high efficiency air filters, including in-situ leak testing failures, are included in the following Honeyman training courses;

Aseptic Processing: Principles in Practice®

Microbial Risk Management During Cleanroom Operations®

Further related information can be found in the following associated briefs:

1. Airborne particle counting using LSAPC – Technical Briefing (PDF)
2. Cleanroom Classification – Technical Briefing (PDF)
3. Cleanroom Testing – Technical Briefing (PDF)
4. High Efficiency Air Filters – Technical Briefing (PDF)
5. Cleanroom Airflow Visualisation – Technical Briefing (PDF)
6. Liquid and Gas Filtration – Technical Briefing (PDF)