PD626 Polypro Replacement Material Evaluation and Selection

Transcription

1 PD626 Polypro Replacement Material Evaluation and Selection This test data provided is based on representative testing done in the lab and is provided to show the similarities between PD626 and 11R12A materials. No testing can replicate all applications or uses of our products. As of the initial release date of this report, we have collected enough data to support the decision to use 11R12A as a substitute for PD626. We may add test data to this report during the product validation and resin transition phase of this process. As data is added, it will be recorded in the revision history table below. Revision History Revision Date Author Description of Changes 1 12/13/2012 J.B. Initial Release 2 12/18/2012 J.B. Fixed three administrative errors: 1. Wrong part number listed in Table 39 heading 2. Table 40 was a duplicate deleted table 3. Wrong part number listed in Table 41 heading 12/18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 1 of 16

2 1. Introduction: PD626 is a specific grade of polypropylene resin used by Colder Products Company since 1988 to mold the affected product lines listed below. The manufacturer of the resin (LyondellBasell) ceased production of this grade of polypropylene as part of a strategy to exit the medical market. After unsuccessful attempts to reverse this decision, Colder embarked on contingency plans. First, Colder secured a significant quantity of PD626 resin to continue production during the replacement resin selection and transition timeframe. We are confident this resin supply is sufficient to support our material transition plan. Next, a cross-functional team identified eleven potential polypropylene replacement resins, based on the following criteria: Homopolymers. PD626 is a homopolymer, meaning the base resin is made of polypropylene only. In contrast, a copolymer has additional ethylene molecules added to the base polypropylene chains in the resin. Same melt flow index as PD626 Mechanical properties similar to PD626 Gamma stable FDA compliant Animal free Biocompatibility certification REACH and RoHS compliant Five of these eleven resins were selected for molding trials. Three of the resins were eliminated from consideration due to inferior results during molding trials. Resins with a higher melt flow exhibited issues with excessive flash, sink and runner strings. The remaining two candidate resins successfully passed the molding trials and were subjected to further evaluation based on dimensional inspection and functional testing including. This report details this additional testing. After evaluating the functional testing data and molded part dimensional inspection data, Flint Hills Resources polypropylene resin grade 11R12A was selected as the replacement to PD626. The manufacturer s data sheets summarized below seemed to indicate the 11R12A would be a drop-in replacement for PD626; our molding trials, manufacturing trials and functional testing confirmed 11R12A as an satisfactory replacement for PD /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 2 of 16

3 2. Applicable Product Lines: The following product lines are affected by this change: PLC12 PMC12 SMC12 with polypropylene insert EFC12 HFC TenTube & SixTube with polypropylene inserts NSH UDC Puncture Seal Body SofTube A complete list of individual part numbers affected by this change is in the appendix. 3. Materials 3.1 Material Property Comparison PD626 Property Value Unit ASTM Method Value 11R12A Unit ASTM Method Resin Manufacturer LyondellBasell Flint Hills Melt Flow Rate 12.0 g/10 min D g/10 min D 1238 Density g/cm 3 D g/cm 3 D 1505 Tensile Yield Strength 4500 psi D D 638 Tensile Yld 13 % D % D 638 Flexural Modulus 160,000 psi D ,000 psi D 790 Notched Izod impact (73 ⁰F, ASTM Method A) (23 ⁰C, ASTM Method A) 0.7 ft-lb/in D ft-lb/in D 256 Deflection 66 psi 181 F D F D 648 Facility Certificates: ISO 9001:2008 Certified Certified OSHA VPP (Voluntary Protection Program) Certified Certified Code of Federal Regulations (FDA) 21 CFR (a)(1)(i) & (c) 1.1a Compliant Compliant 21 CFR (b) Compliant Compliant 21 CFR (c) Compliant Compliant 12/18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 3 of 16

4 Biocompatability PD626 11R12A US Pharmacopoeia Class VI Certified Class VI Certified Chemical Inventories: MSDS Available Available ISO Cytotoxicity Report Available USP 661 Report Available Regulatory & Material Content CAS Drug Master File DMF#16853 DMF#7478 Restriction of Hazardous Substances (RoHS) Compliant Compliant Heavy Metals (ELV Diretive 2000/53/EC) Compliant Compliant Reach (SVHC) Compliant Compliant BSE/TSE Latex BPA, Asbestos, PCBs, & PBBs One additive in this product is derived from animal sources. Natural rubber and Synthetic Latex Free Not used in the manufacture of or the formulation of this product. Coalition of Northeastern Governors (CONEG) Compliant Compliant European Directive 2002/16/EC (Badge, BFDGE, NOGE) Compliant Compliant Proposition 65 Ozone Depleting Chemicals (ODCs) 4. Product Qualification Summary This product may contain two chemical substances at very low levels (less than 1ppm) which are known to the state of California to cause cancer and/or reproductive toxicity under the proposition. Class I & II ODCs listed in the Clean Air Act Amendments of 1990 are not used in the manufacture of or formulation of this product. Animal derived materials are not used in the manufacture or formulation of this product. Natural rubber and Synthetic Latex Free Not used in the manufacture of or the formulation of this product. Compliant Class I & II ODCs listed in the Clean Air Act Amendments of 1990 are not used in the manufacture of or formulation of this product. 4.1 Mechanical Weld Strength Many of the connectors affected by this resin change include a spin welded joint as part of the connector assembly process. The strength of the weld joint is evaluated by burst pressure testing and visual examination of the weld to confirm comingling of polymer across the weld joint. 12/18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 4 of 16

5 4.2 Bubble Leak Performance insert & body connected The integrity of the o-ring seal between an insert and a body is evaluated by submerging the connected coupling set in a water based solution while pressurized at high and low pressures and observing for a continuous stream of bubbles. The solution used is specifically designed to detect small leaks. This testing also confirms the weld joint seals around the entire diameter, another acceptable weld requirement. Bubbles formed anywhere on the connector results in failure. Table 1 Leak test results of Colder part numbers PMCD and PMCD PD626 er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/2012 Table 2 Leak test results of Colder part numbers PMCD and PMCD R12A er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/2012 Table 3 Leak test results of Colder part numbers PLCD and PLCD PD626 er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 5 of 16

6 Table 4 Leak test results of Colder part numbers PLCD and PLCD R12A er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ Bubble Leak Performance insert & body disconnected The integrity of the o-ring seal on the internal valve in an insert or body is evaluated by submerging the coupling insert or body in a water based solution while pressurized and observing for a continuous stream of bubbles. This testing also confirms the weld joint seals around the entire diameter, another acceptable weld requirement. Bubbles formed anywhere on the connector results in failure. Table 5 Leak test results of Colder part number PMCD PD626 5 psi er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/2012 Table 6 Leak test results of Colder part number PMCD R12A er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 6 of 16

7 Table 7 Leak test results of Colder part number PMCD PD626 er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/2012 Table 8 Leak test results of Colder part number PMCD R12A er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/19/2012 Table 9 Leak test results of Colder part numbers PLCD PD626 er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/2012 Table 10 Leak test results of Colder part numbers PLCD R12A er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 7 of 16

8 Table 11 Leak test results of Colder part numbers PLCD PD626 er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/2012 Table 12 Leak test results of Colder part numbers PLCD R12A er Date 1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/ Burst Performance insert & body connected room temperature Mechanical strength of a connector set is evaluated by performing burst testing. Parts are pressurized with water until burst occurs. A safety factor specification is established as a multiplier of rated operating pressure at room temperature before and after parts are exposed to 50 kilograys of gamma irradiation. Table 13 Burst test results of Colder part numbers PMCD & PMCD PD626 er Date 1 >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/2012 Table 14 Burst test results of Colder part numbers PMCD & PMCD R12A er Date 1 >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 8 of 16

9 Table 15 Burst test results of Colder part numbers PLC & PLCD PD626 er Date 1 >360 psi Pass B. M. 11/29/ >360 psi Pass B. M. 11/29/ >360 psi Pass B. M. 11/29/ >360 psi Pass B. M. 11/29/ >360 psi Pass B. M. 11/29/2012 Table 16 Burst test results of Colder part numbers PLCD & PLCD R12A er Date 1 >360 psi Pass B. M. 11/26/ >360 psi Pass B. M. 11/26/ >360 psi Pass B. M. 11/26/ >360 psi Pass B. M. 11/26/ >360 psi Pass B. M. 11/26/ Burst Performance insert & body connected room temperature after gamma irradiation Table 17 Burst test results of Colder part numbers PMCD & PMCD PD626 er Date 1 >480 psi Pass B. M. 11/14/ >480 psi Pass B. M. 11/14/ >480 psi Pass B. M. 11/14/ >480 psi Pass B. M. 11/14/ >480 psi Pass B. M. 11/14/2012 Table 18 Burst test results of Colder part numbers PMCD & PMCD R12A er Date 1 >480 psi Pass B. M. 11/14/ >480 psi Pass B. M. 11/14/ >480 psi Pass B. M. 11/14/ >480 psi Pass B. M. 11/14/ >480 psi Pass B. M. 11/14/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 9 of 16

10 4.6 Burst Performance insert & body connected elevated temperature (160 F) A target safety factor is established as a multiplier of rated operating pressure at rated operating temperature before and after parts are exposed to 50 kilograys of gamma irradiation. Table 19 Burst test results of Colder part numbers PMCD & PMCD PD626 er Date 1 >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/2012 Table 20 Burst test results of Colder part numbers PMCD & PMCD R12A er Date 1 >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/2012 Table 21 Burst test results of Colder part numbers PLC & PLCD PD626 er Date 1 >22 Pass M. W. 11/29/ >22 Pass M. W. 11/29/ >22 Pass M. W. 11/29/ >22 Pass M. W. 11/29/ >22 Pass M. W. 11/29/2012 Table 22 Burst test results of Colder part numbers PLC & PLCD R12A er Date 1 >22 Pass M. W. 11/29/ >22 Pass M. W. 11/29/ >22 Pass M. W. 11/29/ >22 Pass M. W. 11/29/ >22 Pass M. W. 11/29/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 10 of 16

11 4.7 Burst Performance insert & body connected elevated temperature (160 F) after gamma irradiation Table 23 Burst test results of Colder part numbers PMCD & PMCD PD626 er Date 1 >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/2012 Table 24 Burst test results of Colder part numbers PMCD & PMCD R12A er Date 1 >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ >360 psi Pass M. W. 11/29/ Burst Performance insert & body disconnected room temperature Mechanical strength of valved inserts and valved bodies are also evaluated by performing burst testing. Parts are pressurized while not connected to a mating part with water until burst occurs. A safety factor specification is established as a multiplier of rated operating pressure at room temperature before and after parts are exposed to 50 kilograys of gamma irradiation. Table 25 Burst test results of Colder part number PMCD PD626 er Date 1 >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 11 of 16

12 Table 26 Burst test results of Colder part number PMCD R12A er Date 1 >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/2012 Table 27 Burst test results of Colder part number PMCD PD626 er Date 1 >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/2012 Table 28 Burst test results of Colder part number PMCD R12A er Date 1 >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/ >480 psi Pass B. M. 10/24/2012 Table 29 Burst test results of Colder part number PLCD PD626 er Date 1 >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 12 of 16

13 Table 30 Burst test results of Colder part number PLCD R12A er Date 1 >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/2012 Table 31 Burst test results of Colder part number PLCD PD626 er Date 1 >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/2012 Table 32 Burst test results of Colder part number PLCD R12A er Date 1 >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ >480 psi Pass B. M. 11/26/ Cyclic Pressure Fatigue insert & body connected This test is designed to expose differences between materials in their ability to withstand cyclic pressure fatigue. Parts are pressurized for 3 seconds and depressurized for 1 second repeatedly until failure or reaching a cycle limit. The pressure set point is determined experimentally to achieve failure by some parts and not others. Elevated temperature and gamma sterilization to 50 kilograys are also introduced to further expose differences in resins. 12/18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 13 of 16

14 Resin Body Part Table 33 Cyclic pressure fatigue test results PMC product line Insert Part Temp ( F) Pressure (psi) of Cycles Result () er Date PD626 PMCD PMCD ,000 Pass P. dc PD626 PMCD PMCD ,000 Pass P. dc PD626 PMCD PMCD ,000 Pass P. dc R12A PMCD PMCD ,000 Pass P. dc R12A PMCD PMCD ,000 Pass P. dc R12A PMCD PMCD ,000 Pass P. dc Resin Table 34 Cyclic pressure fatigue test results PMC product line gamma sterilized Body Part Insert Part Temp ( F) Pressure (psi) of Cycles Result () er Date PD626 PMCD PMCD ,000 Pass P. dc PD626 PMCD PMCD ,000 Pass P. dc PD626 PMCD PMCD ,000 Pass P. dc PD626 PMCD PMCD ,000 Pass P. dc PD626 PMCD PMCD ,000 Pass P. dc R12A PMCD PMCD ,000 Pass P. dc R12A PMCD PMCD ,000 Pass P. dc R12A PMCD PMCD ,000 Pass P. dc R12A PMCD PMCD ,000 Pass P. dc R12A PMCD PMCD ,000 Pass P. dc Resin Table 35 Cyclic pressure fatigue test results PLC12 product line Body Part Insert Part Temp ( F) Pressure (psi) of Cycles Result () er Date PD626 PLCD PLCD ,000 Pass P. dc PD626 PLCD PLCD ,000 Pass P. dc PD626 PLCD PLCD ,000 Pass P. dc PD626 PLCD PLCD ,000 Pass P. dc PD626 PLCD PLCD ,000 Pass P. dc R12A PLCD PLCD ,000 Pass P. dc R12A PLCD PLCD ,000 Pass P. dc R12A PLCD PLCD ,000 Pass P. dc R12A PLCD PLCD ,000 Pass P. dc R12A PLCD PLCD ,000 Pass P. dc /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 14 of 16

15 4.10 Elevated Pressure Hold insert & body connected The ability of a part to withstand maximum rated operating pressure is tested by holding at maximum pressure for 72 hours and checking for water leaks throughout the test. Table hour hold at room temp & 120psi results of Colder part numbers PMCD & PMCD PD626 11R12A er Date 1 No leak Pass Pass B. M. 11/19/ No leak Pass Pass B. M. 11/19/ No leak Pass Pass B. M. 11/19/ No leak Pass Pass B. M. 11/19/ No leak Pass Pass B. M. 11/19/2012 Table hour hold at room temp & 120psi results of Colder part numbers PLCD & PLCD PD626 11R12A er Date 1 No leak Pass Pass B. M. 12/5/ No leak Pass Pass B. M. 12/5/ No leak Pass Pass B. M. 12/5/ No leak Pass Pass B. M. 12/5/ No leak Pass Pass B. M. 12/5/ Hour Hold at Max Operating Temp & Pressure insert & body connected The ability of a part to withstand the temperature and pressure extremes of the operating parameters is tested by applying maximum pressure with water while the coupling is in a temperature chamber. The connector set is held at maximum temperature and pressure for 72 hours and checked for water leaks throughout the test. Table hour hold at 160 F & 120psi results of Colder part numbers PMCD & PMCD PD626 11R12A er Date 1 No leak Pass Pass B. M. 11/19/ No leak Pass Pass B. M. 11/19/ No leak Pass Pass B. M. 11/19/ No leak Pass Pass B. M. 11/19/ No leak Pass Pass B. M. 11/19/ /18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 15 of 16

16 4.12 Panel Mount Thread Strength The thread strength of a part with threads is evaluated by continuing to apply torque to the panel mount nut until the threads strip out. Five parts are tested at each of three panel thicknesses. Table 39 Panel mount thread strength results of Colder part number PLCD PD626 torque to failure (in lbs) 11R12A torque to failure (in lbs) er Date B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ Poly Tube Fitting (PTF) Thread Strength The thread strength of a part with threads is evaluated by continuing to apply torque to the PTF nut until the threads strip out. Table 41 PTF thread strength results of Colder part number PLCD PD626 torque to failure (in lbs) 11R12A torque to failure (in lbs) er Date B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/ B. M. 11/14/2012 End of Report 12/18/12 Colder Products Company 1001 Westgate Drive, St. Paul, Minnesota Page 16 of 16