Getting pharmaceutical drugs to the market demands high investments for the manufacturers and so it’s critical that product and technical support facilitates manufacturing timescales. With the availability of generic and proprietary filter medias for use in drug manufacturing, selecting the correct filter media is critical to ensure full compliance and optimisation of the filtration process.
Masterfilter can offer our customers full support on Validation of Sterile Filters for their process. Whether it is on existing filters or for the introduction of alternative filters, as part of the ‘control change’ process. With global changes and uncertainties on supply chains, product changes and manufacturing or simply costs, its important that robust validation support is available to minimise risks to production, in critical processes.
The Services we can offer, in addition to the preliminary filterability study; include:
- Viability
- Microbial challenge also with specific micro-organism
- Compatibility
- Adsorption
- Extractables
- Toxicity assessment.
Please contact our office for more information.