CONNECTORS
CONNECTORS
Quick Disconnect Couplings CPC ® Recommended Sterilization Methods
Quick Disconnect Couplings CPC ® Recommended Sterilization Methods
Sterilization Methods Disinfectants: 70°F (20°C), Formalin, ethyl alcohol, etc. Sterilize coupled or uncoupled. Ethylene Oxide, EtO: Four hours, 100% EtO @ 110°F (43°C), up to five repetitions, coupled or uncoupled. Autoclave: Polycarbonate: 250°F (121°C), 30 minutes, up to 10 repetitions. Sterilize uncoupled only. Polysulfone: 270°F (132°C) for 60 minutes, up to 25 repetitions. Sterilize uncoupled only. Steam-Thru Connection: 265°F (129°C) for 30 minutes, up to two cycles. (Part number specific) HFC39: 270°F (132°C) for 60 minutes, up to 25 repetitions for uncoupled units and up to one repetition for coupled units. Electron Beam (E-Beam): Maximum cumulative exposure of 50 kilograys. Sterilize coupled or uncoupled. Gamma: Maximum cumulative exposure of 50 kilograys. Sterilize coupled or uncoupled. Dry Heat: 250°F (121°C), 12 hours, no pressure. Sterilize uncoupled only.
FDA and USDA The U.S. Food and Drug Administration publishes, through the Code of Federal Regulations, standardized criteria which govern the acceptability of materials used in food contact. The U.S. Department of Agriculture publishes similar standards that mirror FDA criteria. Neither agency approves or disapproves products for particular applications. Most CPC ® products are made using resins that comply with applicable FDA or USDA standards. When necessary, the standard O-Ring seals are replaced with specific, recognized materials. Cleanroom Manufacturing CPC ® manufactures certain Life Sciences and Chemical Management product lines in a cleanroom certified by an external testing service to meet or exceed ISO Class 7 (10,000) at 0.5 mm per ISO 14644 and the former Federal Standard 209E. Certification data provided upon request. Regulation of Hazardous Substances The RoHS Directive stands for “the restriction of the use of certain hazardous substances in electrical and electronic equipment.” This directive bans the placing on the EU market of new electrical and electronic equipment containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants. NSF NSF International, based in Ann Arbor, Michigan, develops and publishes consensual criteria that govern the acceptability of materials and equipment used in food and beverage processing. They also do testing to verify the performance of materials or devices to their published criteria. CPC ® lists many of its product lines under the criteria of NSF/ANSI Standard 169 (formerly C-2), which governs components used in food and beverage contact applications.
Method
Ethylene Oxide
E-Beam Irradiation
Gamma Irradiation
Dry Heat
Disinfectants
Autoclave
Isopropyl Alcohol
Ethyl Alcohol
50 Kilograys
50 Kilograys
Formalin
250º F
Metals
Chrome-Plated Brass - CDA 360
N
Y
Y
Y
Y
Y
Y
Y
Polymers
ABS
N
N/A
Y
Y
N
Y
Y
N
Acetal
Y
Y
Y
Y
Y
N
N
N
LDPE
Y
Y
Y
Y
N
Y
Y
N
Nylon
Y
N
N
Y
N
N
N
N
SIP (Steam In Place) Process: Up to 266°F (130°C) for 60 minutes (Steam-Thru Connection) Up to 275°F (135°C) for 60 minutes (Steam-Thru II Connection)
Polycarbonate
Y
Y
Y
Y
Y
Y
Y
Y
Polypropylene
Y
Y
Y
Y
N
Y
Y
N
Polysulfone
Y
Y
Y
Y
Y
Y
Y
Y
Regulatory and Compliance ISO 13485:2003 Certification
Elastomers
ISO 13485:2003 is recognized by regulators around the world as a good basis for addressing medical device design and manufacturing regulatory requirements. It allows us to enhance product safety by proactively identifying and managing product and project risks. Becoming ISO 13485:2003 certified has allowed CPC ® to better control the consistency of manufactured products. ISO 9001:2008 Certification ISO 9001:2008 is a standard which assures consistency of a product ordered by customers. Organizations having ISO 9001:2008 certification have demonstrated compliance to the ISO 9001:2008 requirements by an independent registration authority. CPC ® Quality Management System has been approved and certified under the ISO 9001:2008 standard.
Nitrile/Buna-N
Y
Y
Y
N
N
Y
Y
Y
Silicone
Y
Y
Y
Y
Y
Y
Y
Y
EPR/EPDM
Y
Y
Y
Y
Y
Y
Y
Y
FKM/Viton®
Y
Y
Y
N
N
N
N
Y
Key: Y = Excellent, recommended material for this sterilization method N = No, not recommended N/A = Not applicable
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Customer Service +1 (631) 242 - 3000
Dimensions are for reference only
qosina.com/bioprocess
Customer Service +1 (631) 242 - 3000
Dimensions are for reference only
qosina.com/bioprocess
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