2 May 2018
Porvair Filtration Group, an international leader in filtration and separation, offers validation services for its range of polymeric and disposable cartridge filters for a wide range of pharmaceutical manufacturing processes.
Whilst Porvair Filtration Group’s cartridge filters are designed and manufactured in accordance with international standards for the safe application into pharmaceutical processes, depending on specific project requirements, Porvair 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.
With a dedicated team of quality professionals, all 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 (Food and Drug Administration (FDA) and EU) and the recommendations of the Parenteral Drug Association’s Technical Report No26 ‘Sterilizing Filtration of Liquids’.
Equipped with state-of-the-art facilities, Porvair and their 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 strict Good Laboratory Practice (GLP) guidelines to ensure data integrity.
Senior Scientist, Dr Mozamal Nazir, states “Customers need to validate our products for their specific pharmaceutical processes. 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”.
Porvair Filtration Group is an international leader in the development and supply of high performance, innovative materials and solutions for applications in filtration and separation. Manufacturing in both the UK and the US, and with a network of sales offices and distribution channels throughout the world, its expertise in a wide range of media and the dedication of its design, manufacturing, sales, test and research teams ensure it is at the forefront of filtration technology.