Basic HTML Version
Colder Products Company
®
355
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.
Sip 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)
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 of Colder’s
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.
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. Colder 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.
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. Colder Products
Company’s Quality Management System has been
approved and certified under the ISO 9001:2008 standard.
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.
Cleanroom Manufacturing
Colder Products Company 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
can be provided upon request.
Colder Recommended Sterilization Methods
Regulatory and Compliance
Sterilization Methods