Porvair Filtration Group's cartridge filters are designed and manufactured in accordance with international standards for safe application into pharmaceutical processes, and depending on specific project requirements, the company can also offer a range of validation services.
These include filter compatibility assessments, bacterial challenge testing, extractable analysis, adsorption studies and product wetted integrity test studies.
Validation studies performed by Porvair take into account the critical parameters and worst-case conditions of a particular manufacturing process; adhering to the standards and guidelines established by regulatory authorities such as the Food and Drug Administration (FDA) and the recommendations of the Parenteral Drug Association’s Technical Report No26 ‘Sterilizing Filtration of Liquids.’
Porvair and its partner laboratories are able to closely simulate the process conditions and carry out physio-chemical and microbiological studies to meet and exceed the standards required by regulatory authorities. Studies at partner laboratories are carried out under the umbrella of Good Laboratory Practice (GLP) guidelines to ensure data integrity.
“Customers need to validate our products for their specific pharmaceutical processes," explains Senior Scientist, Dr Mozamal Nazir. "At Porvair we are able to demonstrate bacterial retention and acceptable extractables in actual process conditions. Our validation experience encompasses a broad range of injectable products and manufacturing processes, including antibiotics, vitamins, aggressive-solvent and oil-based formulations. Working with independent laboratories allows Porvair to guarantee that the highest GLP standards are met, and customers are assured that data integrity and quality are safeguarded by a facility with many years experience of providing analytical support in the pharmaceutical sector.”
