Description
Phase TFM™ (PTFE) backed EPDM (Grade E7) diaphragm material was developed specifically for the critical process protocols and 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:
● TFM™ (PTFE) backed EPDM
MATERIAL:
● Modified PTFE (TFM™) with Ethylene Propylene Diene Monomer – (peroxide cured) backing
SIZE:
● DN8 – DN50
(for sizes DN65 and upwards please consult factory for availability)
TEMPERATURE RATING:
● -34º C to +176º C (-30 to +350º F)
REGULATORY COMPLIANCE:
● FDA 21 CFR 177.1550 (a)
● FDA 21 CFR 177.2600 (backing cushion)
● 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 SIP and CIP processes, Compendium waters, buffers, protein solutions and other products. Ideal for applications subjected to intermittent steam service.
● The EPDM backing is fabric reinforced to provide full support for the elastomer and to increase flex performance.
● The EPDM backing is peroxide cured for optimum cross-linking performance and to minimize extractables and leachables. Enhanced surface finish integrity to assist process purity (ASME BPE compliant).
ENHANCEMENTS OVER PTFE:
● Optimum ratio of crystalline and amorphous micro-structure
● Reduced creep and cold flow at elevated temperatures
● Greater dimensional stability
● Greater crack resistance
● Reduced permanent deformation under cyclic load
● Enhanced surface finish integrity to assist purity
MATERIAL (2 PIECE CONSTRUCTION):
● TFM™ grade PTFE wetted face offers the widest temperature range of any polymer. TFM™ grade PTFE is inert to corrosive chemicals, has improved cleanability due to reduced permeation, reduced voids, pore free surface, and excellent anti-stick properties.
● E7 grade (organic peroxide cured) EPDM backing cushion offers excellent mechanical and thermal properties, excellent resistance to compression set, and is fabric reinforced to optimize 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.
