Industry sector: Pharmaceutical
Company activity: Development and manufacture of solutions for animal health
Filtration challenge
A liquid vitamin solution, manufactured for animals, requires a filtration process to ensure the complete sterility of the final product.
Namely
A filtration is considered sterilising if it meets the bacterial challenge.
For further details, please refer to:
The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, *Annex 1 – Manufacture of Sterile Medicinal Products, 2008
ASTM F838-05, superseding HIMA Document No. 3 Vol. 4, April 1982, “Microbial Evaluation of Filters for Sterilising Liquids”
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, September 2004
US Parenteral Drug Association (PDA), Technical Report 40, Sterilizing Filtration of Gases, 2005
US Parenteral Drug Association (PDA), Technical Report 26, Sterilizing Filtration of Liquids, 2008
As this is also a batch process, a short processing time is essential. While the client achieved the required results with the existing filters, they did not have the capacity to process the entire batch, resulting in downtime and production losses.
Pemflow filtration solution
In this context, it is important that the final products are microbiologically stabilised in order to extend their shelf life without altering their nature. In addition, the objective of minimising downtime through a relevant solution also guided our choice.
We therefore proposed a membrane cartridge of the SupaPore VPWA type from AMAZON FILTERS. It uses a high-flow PES membrane combined with a prefiltration membrane.
This dual characteristic gives the product an extended service life.
All cartridges are thermally welded and contain no adhesives. Each unit is pre-rinsed with ultrapure water and undergoes an integrity test prior to final assembly.
- Complies with materials in contact with food criteria in accordance with 21 CFR and European standards
- Meets food contact requirements as detailed in European Regulation (EC) No. 1935/2004
- Meets USP criteria for extractables
We supported our client during the testing and validation phases of the cartridges and provided our filtration expertise on the process.
Two points emerged following the trials:
- Product sterility was achieved, in line with the company’s quality expectations
- A 30% increase in flow rate
In conclusion:
- The required sterile quality level was achieved
- Faster batch processing times were obtained
- The client was able to reduce downtime-related costs, compared with the previously implemented solution
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