PD626 Polypro Replacement Material Evaluation and Selection...This test data provided is based on...

12/18/12 Colder Products Company • 1001 Westgate Drive, St. Paul, Minnesota 55114 Page 1 of 16 Phone: 651-645-0091 • Fax: 651-645-5404 • www.colder.com

CPC, Colder Products and Colder Products Company are registered trademarks with the US Patent and Trademark Office.

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



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 PD626.



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

11R12A

Property Value Unit ASTM Test

Method

Value Unit ASTM Test

Method

Resin Manufacturer LyondellBasell

Flint Hills

Melt Flow Rate 12.0 g/10 min D 1238

12.0 g/10 min D 1238

Density 0.902 g/cm3 D 792

0.900 g/cm3 D 1505

Tensile Yield Strength 4500 psi D 638

4275 psi D 638

Tensile Elongation @ Yld 13 % D 638

9 % D 638

Flexural Modulus 160,000 psi D 790

143,000 psi D 790

Notched Izod impact

(73 ⁰F, ASTM Test Method A) (23 ⁰C, ASTM Test Method A)

0.7 ft-lb/in D 256

0.7 ft-lb/in D 256

Deflection Temp @ 66 psi 181 ˚F D 648

180 °F D 648

Facility Certificates:

ISO 9001:2008 Certified Certified

OSHA VPP (Voluntary Protection Program) Certified Certified

Code of Federal Regulations (FDA)

21 CFR 177.1520(a)(1)(i) & (c) 1.1a Compliant Compliant

21 CFR 177.1520(b) Compliant Compliant

21 CFR 176.170(c) Compliant Compliant



Biocompatability PD626 11R12A

US Pharmacopoeia Class VI Certified Class VI Certified

Chemical Inventories: MSDS Available Available

ISO 10993-5 Cytotoxicity Report Available

USP 661 Report Available

Regulatory & Material Content

CAS Number 9003-07-0

9003-07-0

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 One additive in this product is derived from animal sources.

Animal derived materials are not used in the manufacture or formulation of this product.

Latex Natural rubber and Synthetic Latex Free

Natural rubber and Synthetic Latex Free

BPA, Asbestos, PCBs, & PBBs Not used in the manufacture of or the formulation of this product.

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

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. Compliant

Ozone Depleting Chemicals (ODCs) 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.

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. Product Qualification Summary

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.



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 PMCD100412 and PMCD240212 – PD626

Test sample

Specification Requirement

Observed results:

5 psi

Pass/Fail Observed results: 100 psi

Pass/Fail Tester Test Date

1 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 10/22/2012





Table 2 – Leak test results of Colder part numbers PMCD100412 and PMCD240212 – 11R12A

Test sample


Observed results:

5 psi








Table 3 – Leak test results of Colder part numbers PLCD1000412 and PLCD2400412 – PD626

Test sample


Observed results:

5 psi




2 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/2012 3 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/2012 4 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/2012 5 0 bubbles 0 bubbles Pass 0 bubbles Pass B. M. 11/26/2012



Table 4 – Leak test results of Colder part numbers

PLCD1000412 and PLCD2400412 – 11R12A Test

sample Specification Requirement

Observed results:

5 psi





4.3 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 PMCD100412 – PD626

Test sample


Observed results:5

psi








Table 6 – Leak test results of Colder part number PMCD100412 – 11R12A

Test sample


Observed results:

5 psi










Table 7 – Leak test results of Colder part number PMCD240212 – PD626

Test sample


Observed results:

5 psi








Table 8 – Leak test results of Colder part number PMCD240212 – 11R12A

Test sample


Observed results:

5 psi








Table 9 – Leak test results of Colder part numbers PLCD1000412 – PD626

Test sample


Observed results:

5 psi





Table 10 – Leak test results of Colder part numbers PLCD1000412 – 11R12A

Test sample


Observed results:

5 psi







Table 11 – Leak test results of Colder part numbers PLCD2400412 – PD626

Test sample


Observed results:

5 psi





Table 12 – Leak test results of Colder part numbers PLCD2400412 – 11R12A

Test sample


Observed results:

5 psi





4.4 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 PMCD100412 & PMCD240212 – PD626

Test sample



1 >480 psi Pass B. M. 10/24/2012

2 >480 psi Pass B. M. 10/24/2012

3 >480 psi Pass B. M. 10/24/2012 4 >480 psi Pass B. M. 10/24/2012 5 >480 psi Pass B. M. 10/24/2012

Table 14 – Burst test results of Colder part numbers

PMCD100412 & PMCD240212 -11R12A Test



1 >480 psi Pass B. M. 10/24/2012

2 >480 psi Pass B. M. 10/24/2012





PLC1000412 & PLCD2400412 – PD626 Test



1 >360 psi Pass B. M. 11/29/2012

2 >360 psi Pass B. M. 11/29/2012 3 >360 psi Pass B. M. 11/29/2012 4 >360 psi Pass B. M. 11/29/2012 5 >360 psi Pass B. M. 11/29/2012

Table 16 – Burst test results of Colder part numbers PLCD1000412 & PLCD2400412 -11R12A

Test sample



1 >360 psi Pass B. M. 11/26/2012


4.5 Burst Performance – insert & body connected – room temperature – after gamma irradiation


Test sample



1 >480 psi Pass B. M. 11/14/2012

2 >480 psi Pass B. M. 11/14/2012


Table 18 – Burst test results of Colder part numbers PMCD100412 & PMCD240212 – 11R12A

Test sample



1 >480 psi Pass B. M. 11/14/2012

2 >480 psi Pass B. M. 11/14/2012




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.


Test sample



1 >360 psi Pass M. W. 11/29/2012

2 >360 psi Pass M. W. 11/29/2012

3 >360 psi Pass M. W. 11/29/2012 4 >360 psi Pass M. W. 11/29/2012 5 >360 psi Pass M. W. 11/29/2012

Table 20 – Burst test results of Colder part numbers PMCD100412 & PMCD240212 –11R12A

Test sample



1 >360 psi Pass M. W. 11/29/2012

2 >360 psi Pass M. W. 11/29/2012


Table 21 – Burst test results of Colder part numbers PLC1000412 & PLCD2400412 – PD626

Test sample



1 >225 psi Pass M. W. 11/29/2012

2 >225 psi Pass M. W. 11/29/2012



PLC1000412 & PLCD2400412 – 11R12A Test



1 >225 psi Pass M. W. 11/29/2012

2 >225 psi Pass M. W. 11/29/2012




4.7 Burst Performance – insert & body connected – elevated temperature (160°F) – after gamma irradiation


PMCD100412 & PMCD240212 – PD626 Test



1 >360 psi Pass M. W. 11/29/2012

2 >360 psi Pass M. W. 11/29/2012


Table 24 – Burst test results of Colder part numbers PMCD100412 & PMCD240212 –11R12A

Test sample



1 >360 psi Pass M. W. 11/29/2012

2 >360 psi Pass M. W. 11/29/2012


4.8 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

PMCD100412 – PD626 Test



1 >480 psi Pass B. M. 10/24/2012

2 >480 psi Pass B. M. 10/24/2012




Table 26 – Burst test results of Colder part number PMCD100412 – 11R12A

Test sample



1 >480 psi Pass B. M. 10/24/2012

2 >480 psi Pass B. M. 10/24/2012



PMCD240212 – PD626 Test



1 >480 psi Pass B. M. 10/24/2012

2 >480 psi Pass B. M. 10/24/2012


Table 28 – Burst test results of Colder part number PMCD240212 – 11R12A

Test sample



1 >480 psi Pass B. M. 10/24/2012

2 >480 psi Pass B. M. 10/24/2012


Table 29 – Burst test results of Colder part number PLCD1000412 – PD626

Test sample



1 >480 psi Pass B. M. 11/26/2012




Table 30 – Burst test results of Colder part number PLCD1000412 – 11R12A

Test sample



1 >480 psi Pass B. M. 11/26/2012



PLCD2400412 – PD626 Test



1 >480 psi Pass B. M. 11/26/2012


Table 32 – Burst test results of Colder part number PLCD2400412 – 11R12A

Test sample



1 >480 psi Pass B. M. 11/26/2012


4.9 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.



Table 33 – Cyclic pressure fatigue test results – PMC product line Resin Body Part

Number Insert Part

Number Temp (˚F)

Pressure (psi)

Number of

Cycles

Result (Pass/Fail)

Tester Test Date

PD626 PMCD100412 PMCD240212 160 120 100,000 Pass P. dC. 11-12-2012



11R12A PMCD100412 PMCD240212 160 120 100,000 Pass P. dC. 11-12-2012



Table 34 – Cyclic pressure fatigue test results – PMC product line – gamma sterilized

Resin Body Part Number

Insert Part Number

Temp (˚F)

Pressure (psi)

Number of

Cycles

Result (Pass/Fail)

Tester Test Date







11R12A PMCD100412 PMCD240212 160 120 100,000 Pass P. dC. 10-24-2012 11R12A PMCD100412 PMCD240212 160 120 100,000 Pass P. dC. 10-24-2012



Table 35 – Cyclic pressure fatigue test results – PLC12 product line

Resin Body Part Number

Insert Part Number

Temp (˚F)

Pressure (psi)

Number of

Cycles

Result (Pass/Fail)

Tester Test Date

PD626 PLCD1000412 PLCD2400412 72 120 100,000 Pass P. dC. 11-26-2012





11R12A PLCD1000412 PLCD2400412 72 120 100,000 Pass P. dC. 11-26-2012







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 36 – 72 hour hold at room temp & 120psi results of Colder part numbers PMCD100212 & PMCD240212

Test sample


PD626

11R12A

Tester Test Date

1 No leak Pass Pass B. M. 11/19/2012

2 No leak Pass Pass B. M. 11/19/2012 3 No leak Pass Pass B. M. 11/19/2012 4 No leak Pass Pass B. M. 11/19/2012 5 No leak Pass Pass B. M. 11/19/2012

Table 37 – 72 hour hold at room temp & 120psi results of Colder part numbers PLCD1000412 & PLCD2400412

Test sample


PD626

11R12A

Tester Test Date



4.11 72 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 38 – 72 hour hold at 160°F & 120psi results of Colder part numbers PMCD100212 & PMCD240212

Test sample


PD626

11R12A

Tester Test Date





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 PLCD1200612

Test sample

PD626 torque to failure

(in·lbs)

11R12A torque to failure

(in·lbs)

Tester Test Date

1-1 30 34 B. M. 11/14/2012

1-2 40 42 B. M. 11/14/2012

1-3 32 40 B. M. 11/14/2012

2-1 30 38 B. M. 11/14/2012 2-2 26 32 B. M. 11/14/2012

2-3 32 36 B. M. 11/14/2012

3-1 28 42 B. M. 11/14/2012 3-2 32 38 B. M. 11/14/2012

3-3 32 46 B. M. 11/14/2012

4-1 30 33 B. M. 11/14/2012 4-2 32 30 B. M. 11/14/2012

4-3 33 36 B. M. 11/14/2012

5-1 30 33 B. M. 11/14/2012 5-2 34 34 B. M. 11/14/2012

5-3 40 43 B. M. 11/14/2012

4.13 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 PLCD1200612 Test

sample PD626

torque to failure (in·lbs)

11R12A torque to failure

(in·lbs)

Tester Test Date

1 35 38 B. M. 11/14/2012

2 35 39 B. M. 11/14/2012 3 36 38 B. M. 11/14/2012 4 36 36 B. M. 11/14/2012 5 38 38 B. M. 11/14/2012

End of Report

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