Colder Products Company Telephone (651) 645-0091
1001 Westgate Drive Fax (651) 645-6938
St. Paul, MN 55114 USA www.colder.com
MPC Series, ABS
Product Validation Report
Revision Date: May 29, 2014
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Table of Contents
Item Page Summary …………………………………………………………………………… 3 Specifications…………………………………………………………………….. .. 4 Helium Leak Test.............................................................................................. 6 Cycle Test ...................................................................................................... 8 Burst Test....................................................................................................... 10 Flow Test ...................................................................................................... 12 Certificate of Compliance USP Biological Reactivity Tests, In Vivo, Classification VI – Main Components, ABS ………….... ............................... 13 Intracutaneous Study – White Thumb Latch, Polycarbonate (Non-Fluid Path Component) ………….. ...................................................... 14 Muscle Implantation Study – White Thumb Latch, Polycarbonate (Non-Fluid Path Component) …..... .............................................................. 23 Systemic Toxicity Study – White Thumb Latch, Polycarbonate (Non-Fluid Path Component) ……...... .......................................................... 32 Certificate of Compliance USP Biological Reactivity Tests, In Vivo, Classification VI – O-Ring, Silicone …………….……………………………… 39 Certificate of Compliance USP Biological Reactivity Tests, In Vivo, Classification V – O-Ring, Buna-N …………….……………………………… . 40 Storage Conditions and Shelf Life Statement………………………………… .. 41 Legal Statements………………………………………………………………… .. 42
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Validation Report Summary: Colder Product’s MPC Series, ABS couplings are widely used in medical device applications. MPC couplings are manufactured from USP Class VI. Couplings within this product line include inserts and bodies with hose barbs for 1/4” and 3/8” internal diameter tubing. This report is intended to document specifications of the MPC Series ABS couplings and testing that has been performed on this series. This information is valid for the following part numbers: Part Number Description
MPC17004T 1/4" In-Line Hose Barb Non-valved Coupling Body MPC17006T 3/8" In-Line Hose Barb Non-valved Coupling Body MPC22004T 1/4" In-Line Hose Barb Non-valved Insert with Buna-N Seal MPC22004TM 1/4" In-Line Hose Barb Non-valved Insert with Silicone Seal MPC22006T 3/8" In-Line Hose Barb Non-valved Insert with Buna-N Seal MPC22006TM 3/8" In-Line Hose Barb Non-valved Insert with Silicone Seal
If you desire additional information on the MPC Series ABS couplings, please contact your Colder Products Company representative. Summaries: Specifications: Listing of materials and appropriate operational and sterilization conditions. Biocompatibility Tests: The ABS and platinum-cured silicone materials were tested to USP Class VI criteria. The Buna-N material was tested to USP Class V criteria. Tests performed include: systemic toxicity, intracutaneous studies, and muscle implantation testing. Functional Testing: The MPC03 couplings were tested for burst pressure, helium leak test and cycle test. All tested samples passed. Storage Conditions and Shelf Life: Recommended storage at 50º to 90º F (10º to 32º C) protected from light (UV).
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MPC03 Series, ABS Specifications Materials: Main Components: ABS (white), USP Class VI
Associated Part Numbers – All Main Components Coupling Body Thumb Latch: Polycarbonate (white), USP Class VI, Non-Fluid Path Component
Associated Part Numbers - MPC17004T & MPC17006T O-Ring: Platinum-Cured Silicone (clear), USP Class VI
Associated Part Numbers - MPC22004TM, MPC22006TM Buna-N (black), USP Class V
Associated Part Numbers - MPC22004T, MPC22006T
Tubing sizes: 1/4" and 3/8" ID (6.5mm and 9.5mm ID) Operational Limits: Pressure: Vacuum to 60 psi, 4.14 bar Temperature: -40°F (-40°C) to 160°F (71°C) Sterilization: EtO: Up to five cycles Gamma Irradiation: Up to 50 Kilograys E-Beam: Up to 50 Kilograys WARNING: Pressure, temperature, chemicals and operating environment can affect the performance of couplings. It is the customer's responsibility to test the suitability of CPC products in their own application conditions.
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Part Number Description Coupling Bodies MPC17004T 1/4" In-Line Hose Barb Non-valved
Coupling Body MPC17006T 3/8" In-Line Hose Barb Non-valved
Coupling Body Coupling Inserts MPC22004T 1/4" In-Line Hose Barb Non-valved
Insert with Buna-N Seal
MPC22006T 3/8" In-Line Hose Barb Non-valved Insert with Buna-N Seal
MPC22004TM 1/4" In-Line Hose Barb Non-valved
Insert with Silicone Seal
MPC22006TM 3/8" In-Line Hose Barb Non-valved Insert with Silicone Seal
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Colder Products Company
Engineering Test Lab
1001 Westgate Drive Telephone (651) 645-0091
St. Paul, MN 55114 USA Fax (651) 603-2638
FLOW TEST:
Purpose:
The purpose of the Flow Test is to determine the CV values of the MPC product line.
Procedure:
An MPC coupling set with each available size of hosebarb shall be tested.
Each coupling set shall be installed in the flow test bench. A minimum of five flow rate
and pressure drop measurements shall be recorded: one each at the maximum and
minimum practical flow rates and at least three measurements spaced approximately
equally between the maximum and minimum flow rates. The coupling set shall be tested
with the flow direction from body-to-insert and from insert-to-body.
This procedure shall be repeated without the coupling installed for a tare measurement.
The CV values shall be calculated by using the following equation:
PPPPC OutIn
QTareTare
OutInV
Where:
Q is the flow rate in gallons-per-minute
PIn is a pressure measurement, in pounds-per-square-inch, upstream of the test unit
POut is a pressure measurement, in pounds-per-square-inch, downstream of the test unit
PTare is a pressure measurement taken during the measurement of the flow test bench
The minimum CV value shall be reported.
Results:
The CV value of the MPC with 1/4” hosebarb terminations is 2.8.
The CV value of the MPC with 3/8” hosebarb terminations is 5.5.
Erik Long
Engineering Test Lab Manager
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Further Information:
For additional information regarding the MPC Series polycarbonate couplings, please contact Colder Products Company or your bag manufacturer/local distributor.
Colder 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 Colder Products Company 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 Colder Product Company's written recommendations, specifications and/or instructions, or fails to perform due to normal wear and tear. Colder Products Company does not warrant the suitability of the product for any particular application. Determining product application suitability is solely the customer's responsibility. Colder Products Company 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.
Colder Patent Statement: Colder Products Company takes pride in it’s 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, Colder Products Company has licensed its proprietary technology. Please contact Colder Products to discuss your unique needs. Copyright and Trademark Statements: Copyright © 2006 by Colder Products Company. All rights reserved. Colder Products Company, Colder Products and CPC are registered trademarks with the US Patent & Trademark Office.
