Validation is :
"Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes."
FDA Guideline on Sterile Drug Products Produced by Aseptic Processing – June 1987
3M Purification understands the exacting nature of regulatory demands on today’s pharmaceutical and bioprocess industries and has designed our Validation Support Services program to meet these needs. 3M Purification Validation Support Services streamlines filter regulatory compliance, saving you money, and more critically, time. 3M Purification services extend beyond the validation of sterilizing grade membrane filters to the validation of prefilters. 3M Purification helped pioneer prefilter validation, an emerging industry trend, with our Zeta Plus™ line of cellulosic depth filters.
The goal of 3M Purification Validation Support Services is to ease regulatory compliance for our customers by providing well designed, properly executed, and completely documented test protocols on 3M Purification filter products in their intended application.
Core Services offered by 3M Purification are:
- Integrity Testing,
- Bacterial retention,
- Chemical Compatability,
Additional services include:
- Sterilizing Grade Filter Validation guides,
- Prefilter Regulatory Support Files.
The scope of services offered includes:
- USP Biological Reactivity - Class VI Plastics Test Results,
- On-site Filtration Audits,
- SOP & Test Protocol Development,
- Pre-inspection Audit Support,
- Regulatory Document Preparation Assistance,
- Audits of 3M Purification Manufacturing Sites Contaminant Analysis.
To discuss any of our technologies or your specific requirements with one of our trained technicians contact us