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AseptiQuik® G
Connectors Product Validation Report
AseptiQuik® G Connectors Product Validation Report
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TABLE OF CONTENTS
Validation Report Overview ............................................................................................. 3
Product Specifications ..................................................................................................... 6
Microbial Ingress Test ..................................................................................................... 7
Helium Leak Test .......................................................................................................... 25
Burst Test ..................................................................................................................... 27
Side Load Test .............................................................................................................. 28
Creep Rupture Test ...................................................................................................... 30
Tensile Test .................................................................................................................. 32
Flow Test ...................................................................................................................... 33
Freeze Thaw Test ......................................................................................................... 34
Systemic Injection Test (USP 99/ISO 10993-11) ........................................................... 35
Intracutaneous Injection Test (ISO10993-10) ................................................................ 49
Intramuscular Implantation Test (ISO 10993-6) ............................................................ 65
Physico-Chemical Test (USP 661) ................................................................................ 87
Elastomeric Closures for Injection (USP 381) ............................................................... 88
Hemolysis (ASTM F756-00) .......................................................................................... 89
L929 MEM Elution Test (ISO10993-5 and USP 87) .................................................... 107
Membrane Systemic Toxicity (ISO 10993-11) ............................................................. 120
Membrane Intracutaneous Injection (ISO 10993-10) ................................................... 121
Membrane L929 MEM Elution Test (ISO 10993-5) ...................................................... 123
Material Content Statement ......................................................................................... 124
Cleanliness Statement ................................................................................................ 126
Shelf Life and Storage Conditions ............................................................................... 127
Legal Statements ........................................................................................................ 128
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VALIDATION REPORT OVERVIEW
Genderless AseptiQuik® G Connectors enable quick and easy sterile connections, even in non-
sterile environments. The easy-to-use genderless design simplifies system integration and
minimizes the risk of operator error. The connector’s robust construction provides enhanced
user confidence and reliable performance without the need for clamps, fixtures or tube welders.
Biopharmaceutical manufacturers benefit from a full range of interchangeable 1/4” to 3/4” flow
solutions with the quality and market availability they expect from the leader in single-use
connection technology.
This report is intended to document testing that has been performed on AseptiQuik G
Connectors. This information is valid for the following part numbers:
Part Number Description
AQG17004 AseptiQuik G Body with 1/4" Hose Barb
AQG17006 AseptiQuik G Body with 3/8” Hose Barb
AQG17008 AseptiQuik G Body with 1/2” Hose Barb
AQG17012 AseptiQuik G Body with 3/4” Hose Barb
AQG33012 AseptiQuik G Body with 3/4" Sanitary
If you desire additional information on the AseptiQuik G Connectors, please contact your CPC
representative.
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SUMMARY OF TESTING:
Microbial Ingress Test: AseptiQuik G Connectors were subjected to three types of bacterial
ingress challenges (Dip, Spray and Immersion) to verify the integrity of the AseptiQuik
Connectors. Halves were pre-sterilized with gamma (minimum 50kGy) prior to testing. The
challenge organism selected for all three ingress methods was Brevundimonas diminuta at a
final concentration of approximately 1 x 108 CFU/mL.
Dip Method with Immersion Test – Each half of the connector was dipped into the
challenge organism prior to connection on the membrane side. The dipped parts where
then fully connected and then submerged in the challenge organism. After submersion,
the growth media was introduced to each assembled connector by flushing it through the
connectors and collected.
Spray Method with Immersion Test – Each half of the connector was sprayed on the
membrane side with the challenge organism prior to connection. The halves where then
connected and while the membrane was removed a 2nd spray was applied to the top of
the connectors. After removal of the membranes, the parts where then submerged in the
challenge organism. After submersion, the growth media was introduced to each
assembled connector by flushing it through the connectors and collected.
Results of the three challenges show the units tested negative for bacterial ingress of the
indicator organism after a seven day incubation period at 30-35ºC.
Helium Leak Test: Helium Leak Tests were completed on connected AseptiQuik G Connectors
that were gamma irradiated to 50 kGy to demonstrate sealing performance at the temperature
extremes of 1ºC (39ºF) and 40ºC (104ºF) and pressures of 5 psi (0.35 bar) and 75 psi (5.1 bar).
Results show that all the test units passed the leak limit of 1.0 x 10-5 atm-cc/sec.
Burst Test: To demonstrate that connected AseptiQuik G Connectors maintain an adequate
margin of safety above the rated operating pressures of 75 psi (5.1 bar) after gamma
sterilization (50 kGy nominal) and two autoclave cycles at 130ºC for 60 minutes. The
connectors were then pressurized until a leak was observed. All burst pressures observed were
above the minimum acceptable level of 130 psi (9 bar).
Side Load Test: To demonstrate that connected AseptiQuik G Connectors remain leak free
while side load is applied to the hose barb termination after gamma sterilization (50 kGy
nominal) and two autoclave cycles at 130ºC for 60 minutes. Connected AseptiQuik G
Connectors were subjected to a 15lbf (for 1/4” HB only) or 25lbf side load force in three different
directions to ensure that the product still provides a seal at 5 psi and 75 psi of pressure as well
as under vacuum.
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Flow Test: The Flow Test was conducted in order to determine the Cv of the AseptiQuik
Connector.
The Cv value for the 1/4” HB Connectors was determined to be 1.5.
The Cv value for the 3/8” HB Connectors was determined to be 5.6.
The Cv value for the 1/2” HB Connectors was determined to be 12.0.
The Cv value for the 3/4" HB Connectors was determined to be 32.7.
The Cv value for the 3/4” SANI Connectors was determined to be 16.6.
This value can be used to calculate anticipated flow rates and pressure drops.
Biocompatibility Tests: The polycarbonate and platinum cured silicone materials were tested
at the same time to USP Class VI criteria. All biocompatibility testing was done on parts
after being exposed to 50 kGy of gamma radiation and autoclaved at 135°C (275°F) for 60
minutes. Tests performed include: Systemic Injection, Intracutaneous Injection, Intramuscular
Implantation, Cytotoxicity using MEM Elution, Physicochemical studies, and Hemolysis studies.
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PRODUCT SPECIFICATIONS
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MICROBIAL INGRESS TEST
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HELIUM LEAK TEST
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BURST TEST
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SIDE LOAD TEST
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CREEP RUPTURE TEST
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TENSILE TEST
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FLOW TEST
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FREEZE THAW TEST
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SYSTEMIC INJECTION TEST (USP 99/ISO 10993-11)
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INTRACUTANEOUS INJECTION TEST (ISO10993-10)
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INTRAMUSCULAR IMPLANTATION TEST (ISO 10993-6)
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PHYSICO-CHEMICAL TEST (USP 661)
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ELASTOMERIC CLOSURES FOR INJECTION (USP 381)
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HEMOLYSIS (ASTM F756-00)
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L929 MEM ELUTION TEST (ISO10993-5 AND USP 87)
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MEMBRANE SYSTEMIC TOXICITY (ISO 10993-11)
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MEMBRANE INTRACUTANEOUS INJECTION (ISO 10993-10)
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MEMBRANE L929 MEM ELUTION TEST (ISO 10993-5)
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MATERIAL CONTENT STATEMENT
Material Content Statement for AseptiQuik® Connectors
May 2014
Animal Content
The components used in the manufacture of the AseptiQuik product line are free of animal
derived ingredients based upon declarations from the material suppliers which state the
materials used to produce the components used in AseptiQuik Connectors are free of animal
derived ingredients.
Furthermore, no animal derived materials are used in the processing of the AseptiQuik product
line.
Facilities which mold the AseptiQuik wetted components mold other materials which may
contain animal derived materials. However, purging processes, high injection pressures and the
high molding temperatures (>560F) are expected to eliminate any risk from any polymers that
contain animal derived ingredients used in the same equipment.
Latex Content
CPC has received documentation from its suppliers declaring that all materials in the AseptiQuik
product line are free of Latex.
RoHS
CPC has received documentation declaring that all of the component materials in the
AseptiQuik product line are compliant with Directive 2011/65/EU and related amendments with
respect to the Reduction of Hazardous Substances (RoHS) in regard to maximum allowable
concentrations of PBDEs, PBBs, lead, mercury, hexavalent chromium and cadmium.
REACH SVHCs
CPC has received documentation declaring that all of the flow path component materials in the
AseptiQuik product line are free from substances listed on the ECHA’s list of Substances of
Very High Concern (SVHC) as intentionally added ingredients or as expected process impurities
above concentration limit of 0.1% as of the December 16, 2013 update.
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Melamine
CPC has received documentation declaring that all of the flow path component materials in the
AseptiQuik product line are free from melamine as an intentionally added ingredient.
Phthalates
CPC has received documentation declaring that all of the flow path component materials in the
AseptiQuik product line do not contain the below listed Phthalates as intentionally added
ingredients or as expected process impurities above a concentration limit of 0.1%.
Chemical Name CAS number
Butyl benzyl phthalate (BBP) 85-68-7
Dibutylphthalate (DBP) 84-74-2
Bis (2-ethylhexyl) phthalate (DEHP) 117-81-7
1,2-Benzebeducarboxylic acid diiscodecyl ester (DIDP) 26761-40-0
Diisononyl phthalate (DINP) 28553-12-0
Di-n-octyl phthalate (DNOP) 117-84-0
Diisobutyl phthalate (DIBP) 84-69-5
Di-N-pentyl phthalate (DNPP) 131-18-0
Extractables Testing
CPC has performed extractables testing on the flow path component materials used in the
AseptiQuik product lines. Please email us at [email protected] to request a copy of the
report.
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CLEANLINESS STATEMENT
Cleanliness Testing Performed on All AseptiQuik® Product Lines
CPC manufactures the AseptiQuik product lines in an ISO Class 7 cleanroom. In addition to
ISO Class 7 specifications, CPC tests product for particulate, bioburden, and endotoxin
cleanliness levels during product validation. Please see criteria below.
Particulate
For items produced in the ISO Class 7 cleanroom CPC has the following particulate
requirements. Testing performed per USP<788>.
<25 particles / ml for particulates greater than or equal to 10µm in size
<3 particles / ml for particulates greater than or equal to 25µm in size
Endotoxin
For items produced in the ISO Class 7 cleanroom CPC allows a maximum endotoxin content of
≤ 0.125 EU / ml. This test is conducted per USP <85>.
Bioburden
For items produced in the ISO Class 7 cleanroom CPC allows a maximum microbial load or
bioburden content of ≤10 CFU / 100ml. This test is conducted per USP <1231>.
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SHELF LIFE AND STORAGE CONDITIONS
Statement Regarding Storage Conditions and Shelf Life of AseptiQuik G Connections
The shelf life of a connector is dependent upon the connector materials and the storage
conditions. In general, it is best to store any product in an environment shielded from light at a
temperature between 50oF and 90oF.
The shelf life of CPC’s AseptiQuik G connections is estimated to be 3 years minimum from date
of manufacture based on accelerated aging testing, if the storage conditions comply with these
shown above. Aging was performed post gamma sterilization.
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LEGAL STATEMENTS
Further Information:
For additional information regarding the genderless AseptiQuik G Connector, please contact
Colder Products Company or your bag manufacturer/local distributor.
CPC Warranty Statement: Colder Products Company warrants its products against defects in
workmanship and materials a period of 12 months from the date of sale by CPC to its initial
customer (regardless of any subsequent sale of the products). This warranty is void if the
product is misused, altered, tampered with or is installed or used in a manner that is
inconsistent with CPC’s written recommendations, specifications and/or instructions, or fails to
perform due to normal wear and tear. CPC does not warrant the suitability of the product for any
particular application. Determining product application suitability is solely the customer's
responsibility. CPC is not liable for special, indirect, incidental, consequential or other damages
including, but not limited to, loss, damage, personal injury, or any other expense directly or
indirectly arising from the use of or inability to use its products either separately or in
combination with other products. ALL OTHER WARRANTIES EXPRESS OR IMPLIED,
WHETHER ORAL, WRITTEN OR IN ANY OTHER FORM, INCLUDING BUT NOT LIMITED TO
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE
EXPRESSLY EXCLUDED.
CPC Patent Statement: CPC takes pride in its innovative quick disconnect coupling solutions,
many of which have been awarded United States and International patents. Colder Products
Company has a strong tradition of leadership in the quick disconnect market, and aggressively
pursues and protects its proprietary information and intellectual property. In cases where it is
practical and as a benefit to its customers, CPC has licensed its proprietary technology. Please
contact CPC to discuss your unique needs.
Copyright and Trademark Statements: Copyright © 2015 by Colder Products Company. All
rights reserved. Colder Products Company, Colder Products and CPC are registered
trademarks with the US Patent & Trademark Office.
