Quality, performance and reliability of all Pure-Flo diaphragms is assured through extensive testing and comprehensive controls on the diaphragm material manufacturing process. Pure-Flo has years of experience in the development of diaphragm materials for use in the challenging applications within the Pharmaceutical and Bioprocessing industries. This knowledge is applied to each new material development. Successful completion of all appropriate regulatory requirements and operational performance benchmarks must be met before any new diaphragm material is released to the industry.

Typical conformance and performance tests:
• FDA extraction per 21CFR177.2600 (Elastomers)
• FDA extraction per 21CFR177.1550 (PTFE)
• USP28 Class VI Chapters <87> and <88>
• Cycle testing using air, water, and/or steam
• Cycle testing against vacuum and positive pressure at 100% and 0% êP conditions
• Cycle testing at ambient and elevated temperatures

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.