Regulatory validation burden
Bacterial challenge, integrity test correlation and extractables studies must exist before the filter can be used in a licensed process.
Life Sciences · Industry
Sterilising-grade filtration with validation packages, extractables data and documentation written for regulatory review.
- Validated bacterial challenge
- 10⁷ CFU/cm²
- Cleanroom element assembly
- Class 8
- Biological reactivity compliance
- USP VI
The constraint
Filtration that survives the audit as well as the process.
In pharmaceutical manufacturing the filter must perform and the paperwork must prove it performed. A filter without a validation package is unusable regardless of how well it filters.
Standards we work to
- FDA 21 CFR 211
- EU GMP Annex 1
- USP Class VI
- ASTM F838
- ISO 14644
Extractables and leachables
Every material in the flow path is a potential contributor to the drug product and must be characterised and documented.
Steam sterilisation cycling
Repeated SIP degrades media and seals; a defined cycle count with post-cycle integrity verification is mandatory.
Change control rigidity
Any supplier-side change triggers requalification, so notification of change agreements are as important as the product.
Applications
Where we filter in pharmaceutical & biotech
- 01Sterile filtration of parenteral and ophthalmic products
- 02Fermentation air supply and vent filtration
- 03WFI and purified water distribution loops
- 04Buffer and media preparation
- 05Cleanroom HVAC terminal filtration
- 06Tablet-press and granulation dust containment
Recommended platforms
What we typically specify here
Proof
Pharmaceutical & Biotech case studies
Next step
Send us your pharmaceutical & biotech stream data.
Our applications engineers work to the standards listed above every week. You will not be explaining your industry from first principles.
Or call +91 79 4890 2200 · sales@worldasatech.com