Traceability

All diaphragm materials and physical properties are batch traceable via permanent codes molded into the diaphragm tabs. The molding date, material type, and diaphragm size provide traceability to original batch records. Click here to see Diaphragm tab codes and date codes (pg. 13 of diaphragm brochure).

Validation

ITT Pure-Flo recognizes the importance of product and process validation to the Pharmaceutical and Bioprocessing industries. A complete selection of documentation is available to facilitate the validation process.

• Diaphragm ingredients and processing aids are FDA compliant
• Physical properties, raw materials, compounding and molding process are documented
• All diaphragms are available with FDA Certificate of Conformance
• 21CFR177.2600 - Elastomers
• 21CFR177.1550 - Perflourocarbon
• All diaphragms are available with USP 28 Class VI Certificate of Conformance
• Chapter 87 In-Vitro
• Chapter 88 In-Vivo
• Certificate of Compliance to EMEA/410/01 "Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products" available upon request
• Certificate of Traceability to EN 10204 3.1 B available upon request
• Third party testing and in-house performance data available upon request

Note: ITT Pure-Flo diaphragms are qualified and approved for use with Pure-Flo diaphragm valves. Other makes of diaphragms are not recommended and/or guaranteed by Pure-Flo for use with Pure-Flo valves.