
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 | 1/4-4 | 6-100 | -30-300 | -34-149 | x | x | ||
| P | Buna N | 1/2-12 | 15-300 | 10-180 | -12-82 | x | x | x(2) | |
| TM17 | PTFE | 1/4-6 | 6-150 | -30-350 | -34-176 | x | x(1) | x | |
| W1 | White Butyl Rubber | 1/2-8 | 15-200 | 0-225 | -18-107 | x | x |
(1) Class I applications
(2) Class III applications