
The Pharmaceutical and Biotech industries consider a number of factors to determine the best diaphragm solution for a given process or application.
Key factors include:
• Regulatory Compliance
• FDA
• USP 28
• 3A
• Biocompatability
• Material extractibles
• Application temperatures
• Cleaning in place
• Steaming in place
• Passivation
• Failure mode
Applications within the Biotech industry are particularly sensitive to diaphragm materials because of the fact that many of the processes within the industry utilize living organisms. A balance or compromise must be struck between all of the key factors listed. Regulatory compliance in most cases is not sufficient by itself to guarantee a properly functioning system.
The worldwide network of ITT Pure-Flo technical resources are available to assist in determining the proper diaphragm for your application.
| Grade | Material | Inch | DN | °F | °C | FDA | USDA | 3A | USP |
| B | Black Butyl Rubber | 1/4-12 | 6-300 | -20-250 | -20-121 | x | x | ||
| 17 | EPDM (1) | 1/4-4 | 6-100 | -4-194 (2) | -20-90 (2) | x | x | ||
| P | Buna N | 1/2-12 | 15-300 | 10-180 | -12-82 | x | x | x(3) | |
| TM17 | PTFE | 1/4-6 | 6-150 | -0-350 | -34-176 | x | x(4) | x | |
| W1 | White Butyl Rubber | 1/2-8 | 15-200 | 0-225 | -18-107 | x | x |
(1) For high temperature and/or high cycle applications, contact ITT.
(2) Temperature range is as follows:
-4–194°F (-20–90°C) for liquid applications
-22–302°F (-30–150°C) for intermittent steam
-22–285°F (-30–140°C) for continuous steam
(3) Class III applications
(4) Class I applications