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Biotech Regulatory Support

Biotech Regulatory Support Documentation

Product compliance documentation

You talk, we listen – simplifying document retrieval to save you time.  We pride ourselves in offering innovative quality products that meet industry regulations and standards – to protect what matters most. In this regulatory page, you can find the documentation to support how our products conform to regulations, directives, and standards.   

 

Can’t find what you’re looking for?  Use our ‘Contact Us’ page to let us know your questions and suggestions.

 

Pall Allergen Statement

This statement is an extract from Pall’s Supplier Guidance on Disallowed and Controlled Substances (E962). This statement is intended to provide information regarding the use of allergenic substances in Pall Biotech disposable pharmaceutical-grade filters, TFF cassettes, and biotechnology Single Use Systems (SUS).

Pall Latex Statement

Use of Natural Latex

This statement is intended to provide information regarding the use of natural latex rubber in Pall Biotech disposable pharmaceutical-grade filters, TFF cassettes, and biotechnology Single-Use Systems (SUS).

Please be aware that Pall Corporation do not knowingly employ materials which are constructed directly from natural rubber latex. Also note that Pall Biotech does not test final product(s) for the absence of specific compounds related to natural rubber latex allergies.

Pall Melamine Statement

Contamination identified in FDA’s Guidance for Industry – Pharmaceutical Components at Risk for Melamine Contamination (Aug 2009), in the manufacturing processes of pharmaceutical-grade filters. Additionally, to the best of our knowledge melamine is not a component in the materials we purchase to manufacture our Biotech products. Therefore, we do not expect that melamine would be a potential leachable from our pharmaceutical-grade filters.

Pall GMO Statement

This statement is intended to provide information on the exclusion of GMO substances in the manufacture of Pall Biotech disposable pharmaceutical-grade filters, TFF cassettes, and Single-Use Systems (SUS).

Pall does not specify or intentionally use any GMO substances in the manufacture of the above listed products. The wetted components (of the above listed products) therefore are constructed from primary materials which are polymeric in nature. However, since the raw materials we purchase are not certified as ‘non-GMO’, we cannot exclude the possibility that genetically modified material may be present in a trace quantity as an incidental additive deriving from the raw material manufacturing process.

Pall TSE BSE Statement

Minimization of Transmission of Bovine Spongiform Encephalopathy

(BSE) & Transmissible Spongiform Encephalopathy (TSE)

Pall Corporation do not knowingly employ materials of direct animal origin i.e. animal parts, tissues, or body fluids, however to assist our customers in performing a TSE/BSE risk assessment, we are pleased to provide the following information.