PTFE Diaphragm Valves for Pumps for Pharmaceutical and Biotech Applications
In pharmaceutical manufacturing, where batch or continuous production procedures are followed, the key issues that must be addressed are cleaning validation, product containment, separation of process, and system sterilisation. Central to these issues is transferring fluids within the processes, plus there is the problem of the liquid becoming trapped within the process. Trapped liquid leads to stagnation leading to product contamination.
The Importance of Diaphragm in Pumps for Pharma, Biotech, and Life Science Industries
Pumps used in the transfer of media throughout the manufacturing processes are undertaken in sterile conditions. All diaphragm’s surfaces and components that come into contact with the pumped media must be suitable for SIP/CIP procedures. To satisfy the innovations and enhancements needed by the pharmaceutical industry, the materials used for pump diaphragms must accommodate these environments.
Use of PTFE Diaphragms in Pharmaceutical Pumps
When it comes to use of plastic diaphragms and valves in pharma industry pumps, reliability over a wide range of operating conditions is critical. Any break-up of the diaphragm surface has the potential for cross-contamination of the pumped media and liquid/vapour leakage. Contamination can cause necessity for disposals of complete media lots. Saint-Gobain’s Flex Barrier products maintain high purity, engineered from the highest quality virgin Polytetrafluoroethylene (PTFE) resins reducing media waste.
Saint-Gobain's CHEMFILM® high quality materials offer almost universal chemical resistance with low permeability and extremely low moisture absorption characteristics (< 0.01%) resulting in outstanding corrosion resistance.
Flex barriers boast a tensile strength range from min. values of 3500 psi/25 N/mm², representing an exceptional resistance to elongation fatigue. This is reinforced by the high elongation at break, or fracture strain, of at least 280% (min. values) and a tensile modulus of 80,000 psi.
The high tensile strength allows for the diaphragm to handle varying flow rates, inhomogeneous media, changes in pressure, and varying temperatures.
A Hygienic Valve Solution Tailored for Pharmaceutical Diaphragms
To ensure no batch-to-batch containment, the pump systems for pharma must be easy to clean and drain. Saint-Gobain’s specialized surface treatments and a proprietary process imparts high flex life, and high smoothness of the material.
With a wide variety of specially designed bondable versions available, the film can be laminated to rubber carriers, minimising any voids, and improving overall diaphragm flexibility. This increased flexibility within the pump system dramatically reduces the chance of contamination and improves cleaning ability.
Saint-Gobain Flex Barrier materials made from the purest PTFE resins, comply with the following regulations, making them an excellent choice for diaphragm material.
- FDA 21 CFR 177.1550
- (EC) No 1935/2004
- (EU) No 10/2011
- (EC) No 23/2006 (GMP)
- USP Class VI
- 3-A Sanitary Standard
Material Selection Guide for Pharmaceutical & Biotech Diaphragm Pumps and Valves
|Material||Product Code||Thickness, mm||Key Features||Optional Features|
|PTFE Skived Film Premium||0100||0.025 - 3.0||Universal -- Great bending fatigue strength||Customization available|
|PTFE Skived Film Modified||0200||0.025 - 3.0||Excellent elongation at break||Customization available|
|PTFE Skived PTFE Film Flex Barrier||LP01
0.4 - 1.0
|Developed for applicaitons where outstanding flex life is required||Customization available|
For all our materials, we offer customization options tailored to suit your needs. Please Contact Us to discuss your requirements or to request a call back from one of our pump diaphragms technical experts.