Contract Design, Manufacture and Assembly of Regulatory Compliant Polymer Products
News Mar 12, 2010
Porvair Filtration Group, a developer and manufacturer of novel, high performance sintered porous plastic materials and products for life science applications, has opened a new Class 100000 (ISO Class 8) clean room facility at its Wrexham, UK site.
The new clean room facility is part of ongoing investment to produce and package regulatory controlled materials and assembled products in a clean environment.
Porvair Filtration Group has over 25 years experience in providing design, manufacture and assembly solutions that meet OEM customer requirements, as well as standards set by the regulatory authorities. Manufacturing of these specialist, high performance products is underpinned by an ISO 9001-2000 quality assurance program, cGMP practices and clean room environment to ensure products meet the stringent requirements of the Life Science industries.
To complement contract manufacturing for the Life Science market, Porvair Filtration Group has developed a new highly purified porous polymeric material - BioVyon™. Chemically modified using novel technologies the resultant polymeric materials are being adopted by pharmaceutical, biotech, healthcare and analytical companies for filtration, separation, purification, diffusion and fluid transfer applications.
BioVyon™ standard materials are primarily polyethylene or polypropylene sintered porous plastic materials, made by proprietary cGMP processes with low extractable and particle shedding levels.
Available in pore sizes from 5 to 100 micron (mean flow pore) the materials are available in sheet, roll, cut shapes or molded and, depending on the particular specification, these materials have regulatory approvals that meet FDA, WDA and USP requirements.