A new parenteral line needed a fully validated sterilising-grade filtration train, with documentation ready for regulatory submission, inside a fixed launch window.
- Enquiry to qualified installation
- 9 weeks
- Bacterial retention at 10⁷ CFU/cm²
- 100%
- Regulatory observations at inspection
- 0
- Market launch achieved
- On date
The challenge
The client had a fixed market-launch date and a filtration validation programme that had already slipped twice with a previous supplier. The blocking item was not the hardware — it was product-specific bacterial challenge testing and extractables data generated against their actual formulation.
How we approached it
- 01A dedicated validation engineer was assigned and co-located with the client's qualification team for the programme duration.
- 02Bacterial challenge testing against B. diminuta was run on the actual product rather than a surrogate, at worst-case process conditions.
- 03Extractables studies used the client's own solvent system, with analytical results delivered in their required reporting format.
- 04Integrity test correlation was established for the product-wetted condition, so operators test with product rather than water.
What we delivered
A VESSA-SAN sanitary housing train with double-layer PES AXION-ST sterilising-grade cartridges, released with a complete validation package: bacterial retention, extractables and leachables, integrity test correlation, and a full material traceability data book indexed for regulatory submission.
We had been through two suppliers. The difference here was that the validation engineer sat with our team and understood what a regulator would ask before we did.
Project facts
- Client
- Top-20 global pharmaceutical manufacturer
- Industry
- Pharmaceutical & Biotech
- Location
- Hyderabad, India
- Year
- 2026
Measured results
- 9 weeks
- Enquiry to qualified installation
- 100%
- Bacterial retention at 10⁷ CFU/cm²
- 0
- Regulatory observations at inspection
- On date
- Market launch achieved
What went in
Other programmes
Next step
Tell us what is in the stream.
Flow rate, contaminant, target rating, chemistry and available pressure. Six inputs, and our engineers return a staged design with the sizing basis attached — typically inside 48 hours.
Or call +91 79 4890 2200 · sales@worldasatech.com