Description
Phase Grade E7 EPDM diaphragm material was developed specifically for critical applications in the Biopharmaceutical Industry.
It has been developed and extensively tested in the manufacturing plant’s development laboratory and third-party tested at the BioProcess Institute.
GRADE:
● E7
MATERIAL:
● Ethylene Propylene Diene Monomer (peroxide cured)
SIZE:
● DN8 – DN50
(for sizes DN65 and upwards please consult factory for availability)
TEMPERATURE RATING:
● -40 ºC to +110 ºC ( -40 ºF to +230 ºF) Liquid Media
● -30 ºC to +150 ºC ( -22 ºC to +302 ºC)
Max Steam Sterilization
(max 180 minutes per cycle)
REGULATORY COMPLIANCE:
● FDA 21 CFR 177.2600
● USP Class VI, <87>, <88>
● ISO 10993-5, -6, -10, -11
● ASME BPE part SG
● Certified Animal Derived Ingredient Free
● EMEA /410/01 TFE/BSE
● Fully lot traceable to EN 10204 3.1
FEATURES:
● Improved resistance to steam, WFI and commonly used CIP chemicals, buffers, protein solutions and other products
● Fabric reinforced to provide full support for the elastomer face and to increase flex performance
● Peroxide cured for optimum cross-linking performance and to minimize extractables and leachables
● Reduces the need to re-torque and assures seal integrity
● Enhanced surface finish integrity to assist process purity (ASME BPE compliant)
CONSTRUCTION:
● Grade E7 EPDM
● Organic Peroxide cured
● Excellent resistance to compression set
● Excellent mechanical and thermal properties
● Fabric reinforced to optimise flex
DIAPHRAGM TRACEABILITY:
● All diaphragm materials and physical properties are batch traceable with permanent codes moulded onto the diaphragm. Moulded information includes manufacturing date/cure date, material grade, and diaphragm size.
