porosity pore size ponce va-12-187-st ver 5

7/28/2019 Porosity Pore Size Ponce VA-12-187-ST Ver 5

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Verification Protocol

VA 12-187-ST, Version 1

Pore Size and Porosity Testing after Fiber Metal Diffusion Bonding and Thermal Soak Cycles

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VA 12-187-ST

Pore Size and Porosity Testing after Fiber Metal

Diffusion Bonding and Thermal Soak Cycles

Zimmer Manufacturing BV

Mercedita, Ponce PR


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Document Revision History

VersionNo.

Date Description of Change Rationale forChange

Author

1.0 06/27/12 New document

Initial document

Link to ZCAP 12-

011

Enrique Pomales


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Table of Content

1.0 PURPOSE ............................................................................................................................. 5

2.0 SCOPE .................................................................................................................................. 5

3.0 PROJECT BACKGROUND................................................................................................. 5

4.0 RISK ASSESSMENT ANAL YSIS ....................................................................................... 6

5.0 PROCESS/ SYSTEM DESCRIPTI ON ................................................................................ 7

6.0 REFERENCES ..................................................................................................................... 9

7.0 DEF INI TI ONS AND SYMBOLS/ ACRONYMS .............................................................. 12

8.0 VERIF ICATI ON STRATEGY ........................................................................................... 13

9.0 ROLES AND RESPONSIBI L I TI ES ................................................................................. 2410.0 GENERAL EXECUTION PROCEDURE ........................................................................ 24

11.0 INDI VI DUAL TEST PROTOCOLS (I TPS)/ TESTS CHECKL IST ................................ 28

12.0 VERIF ICATI ON DISPOSI TI ON ...................................................................................... 34

13.0 PROTOCOL ATTACHMENTS AND APPENDIXES ..................................................... 35


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1.0 Purpose

The purpose of this protocol is to determine whether the Trilogy cups/Acetabular

products manufactured as per current processes OCP 17.008-ZC Rev 19 at ZMBV meetspecifications for lot release, as outlined criteria for Pore size and Porosity per ZES 2A-

132.

2.0 Scope

This protocol covers the Fiber Metal Diffusion Bonding Process of Trilogy/ Acetabular

Cup product families, and the thermal cycle of HATCP/ Trilogy Spiked Cup productfamilies, currently manufactured in cell 201/ 205, HIP Business Unit.

Product families/ part numbers included in the scope of this protocol are listed in Table 1:

Trilogy/ Acetabular Cup product families. Refer to Appendix 4 for a detailed list of partnumbers per contract family (CF).

Table 1: Trilogy/ Acetabular Cup Product Families

CF

Identification

CF Description U.S. Class III

PMA Devices

HATCP CUPS (40-6200-XXX-XX)E31 HATCP Trilogy Multi (40-6200-XXX-20) No

E32 HATCP Trilogy Solids (40-6200-XXX-21)

E33 HATCP Trilogy Cluster (40-6200-XXX-22)E34 HATCP Trilogy Spiked (40-6200-XXX-23)

E35 HATCP Trilogy Unit Hole (40-6200-XXX-24)

AB CUPS (40-6400-XXX-XX)E37 HATCP AB CUPS (40-6400-XXX-20) Yes

E38 HATCP AB CUPS (40-6400-XXX-22)

CUPS (00-6200-XXX-XX)

G04 Trilogy Multi (00-6200-XXX-20) No

G05 Trilogy Solids (00-6200-XXX-21)

G07 Trilogy Spiked (00-6200-XXX-23)

G09 Trilogy Cluster (00-6200-XXX-22)

G13 Trilogy Unit Hole (00-6200-XXX-24)

3.0 Project Background

Two (2) vacuum furnaces are currently used for the Fiber Metal Diffusion BondingProcess of Trilogy/ Acetabular Cup product families, and the thermal cycle of HATCP/

Trilogy Spiked Cup product families.


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Diffusion bonding process in vacuum furnaces was last validated under VA 06-031/ 033.

Product acceptance criteria included: tensile strength, microstructure and fiber metal

chemistry.

ZES 2A-60 Diffusion Bonding Parameters for Fiber Metal, Revision R, which was the

effective specification by then, included the following requirements: oxygen content plus

nitrogen content in monitoring coupons not to exceed 0.35 weight percent and bondingintegrity evaluated on all fiber metal-coated implants according to ZES 4J-02 Laser

Method Spec for Fiber Metal and Trabecular Metal Inspection.

ZES 2A-60, Revision S was made effective on 07/24/07, and added the minimum tensilestrength requirement of 20 MPa (2900 psi) to the quality requirements.

ZES 2A-60, Revision T was made effective on 03/24/09, and added the followingrequirements:

The porous coating shall have an average volume porosity of 30-70%. The porous coating shall have an average pore size between 100 and 1000

microns.

ZES 2A-60, Revision T was made obsolete on October 2011 by ZES 2A-132, Trabecular

Fiber Metal Diffusion Bonding Process Parameters.

ZES 2A-132, Trabecular Fiber Metal Diffusion Bonding Process Parameters

specification covers the process parameters for diffusion bonding for Titanium FiberMetal (FM, ZES 2A-44) to Tivanium alloy (Ti-6Al-4V, ZES 2A-81, ZES 2A-82) for

medical implants, as well as all of above listed product quality requirements.

ZES 4L-02 Electron Beam Welding (EBW) Acetabular Shell specification covers the

placement and electron beam welding (EBW) of Ti-6Al-4V spikes into Ti-6Al-4V

Acetabular cups, as well as post weld processing, including the thermal cycle in thevacuum furnaces. ZES 4L-02 requires penetrant inspection be performed on all spiked

cups using ZES 4H-01 Penetrant Inspection.

4.0 Risk Assessment Analysis

Porosity and Pore size have been categorized as key quality attributes for these types of

implants (Trilogy/Acetabular Cups) by the Code of Federal Regulations " 21CFR

888.3358" enacted by law and overseen by Federal Drug Administration . Porosity and

Pore Size are indeed pivotal attributes for the market acceptability of these products.


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Similar process were comparable with (Trilogy/Acetabular Cups) with the purpose of

assigning criticality. The World cup FM shell FIP indicated that the Diffusion bondingprocess is a criticality of 5.

ZMBV has manufactured these Trilogy since 1995 and Trilogy Spike since 1997 for total

of 510,394 units in the last three years.

Nevertheless Harms Severity and Detection Levels associated with Hazard Conditionssuch as not meeting Patient/Customer Expectations, implant intended use and human

factors are rated serious, these are considered negligible since failures are not likely to

occur even in extreme conditions. As a consequence an assessment of "RPN" Risk Priority

Number = Occurrence x Severity x Detectability of Hazardous Conditions per GSOP15.903 (SOP 15.903) Process Failure Modes & Effects Analysis shows peril is reduced

and no additional risk controls are required therefore is being deemed satisfactorily to set

An Acceptance Quality Level of 1.0% comparable to the diffusion bonding process whichresembles equivalent criticality

5.0 Process/ System Description

The shells are machined from titanium alloy (Tivanium, Ti-6Al-4V) bar stock (refer to

ZES 2A-81 Wought Ti-6Al-4V). A porous surface of commercially pure (CP) titanium

fiber metal is metallurgical bonded to the outer surface of the shell, allowing for bone ingrowth or enhanced cement fixation. In some cases, hole patterns are machined on the

semi-finished cup to use bone screws as additional form of fixation. Fixation screws can

be inserted through the holes for additional fixation with the Acetabular bone. In thespiked design (where three spikes protrude from the outer surface) the spikes are impactedinto the Acetabular for adjunctive fixation. Additionally, there is a series of shells coated

with Calcicoat Ceramic Coating (HATCP) operations performed at Warsaw (not part of

ZMBV Operations) for enhanced fixation to the bone.

Diffusion Bonding Process:

The intended function of the diffusion bonding process is to adhere a fiber metal

hemisphere (porous material composed of Commercially Pure (CP) titanium interwoven

wires) to a titanium or Tivanium (Ti-6Al-4V) alloy substrate by means of a

metallurgical bond.

Thermal Cycle for HATCP/ Trilogy Spiked Cups:

The thermal cycle will encourage new grain growth to minimize the effect of electronbeam welding (EBW) on the material (Ti-6Al-4V spikes placed into Ti-6Al-4V

Acetabular cups). In addition the thermal cycle will remove the discoloration caused by

welding.


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Equipment:

Currently used Vacuum Furnaces, as well as related Ancillary Equipment used in cell

205 for the preparation of the cups prior diffusion bonding, are listed in the following

table.

Description Asset No. Model Serial No.

Vacuum FurnaceZC00196 HL34BH 2339

ZC00496 HL34 2159 (1386)

Balances

25-1050-000-62X

SIWSBBP-1-3-H

0026405791

25-1050-000-62Y 0026405788

25-1050-000-62AA 26405789

Cut & CrimpZC00167 N/A N/A

ZC01565N/A

06347

PresotechnickPress (BenchPress)

ZC00212Calibration ID:

25-1050-001-24B MC 4.8

262-90-012


25-1050-001-24C MC 9

089-90-867

Wabash Press

ZC0021425-1050-001-24A

DA 300-1818-SM8999

ZC0184825-1050-001-24D

MPI SMX 1212 300 Ton8856

Presotechnick

Press


25-1050-001-19B

MC 01.027E19007100269

9

PneumaticScrewdrivers

25-1050-001-11PLT30B-11C

H15753

25-1050-001-11S H85781


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6.0 References

The following references were consulted in the development of this document:

Qualification/ Validation Procedures, Specifications, and Related Documents

Document

NumberRev. Document Title

OCP 5.980-ZC 18 Validation Procedure

ZES 2A-44 1 Commercially Pure Titanium Wire for Fiber MetalFabrication

ZES 2A-60

(Obsolete)T Diffusion Bonding Parameters for Fiber Metal

Specification

ZES 2A-81 R Wrought or Forged Tivanium, TI-6AL-4V Alloy

ZES 2A-132 D Trabecular/ Fiber Metal Diffusion Bonding Process

Parameters

ZES 2A-156 A Quality Requirements for Diffusion Bonded Fiber Metal

Acetabular Cups

ZES 4H-01 X Penetrant Inspection Specification

ZES 4J-02 AELaser Method Spec for Fiber Metal and Trabecular Metal

Inspection

ZES 4L-02 B Electron Beam Welding (EBW) Acetabular Shell

Specification

ANSI/ASQ Z1.9Version:

2008

Sampling Procedures and Tables for inspection by

variables for percent nonconformingANSI/ASQ Z1.9-2008


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Previous Qualification/ Validation Related Documents

Document Number Document Title

VA 10-414 Installation, Operational, and Performance Qualification for

Wabash MPI SMX 1212 300 Ton Press ZC01848

VA 07-070

VA 10-027

Installation and Operational Qualification for Wabash Fiber Metal

Compaction Press ZC00214

Performance Qualification for Wabash Fiber Metal Compaction

Press ZC00214

VA 08-157 Installation and Operational Qualification for Cut & Crimp

ZC01565

VA 94-015 QV for Cut & Crimp ZC00167

VA 06-033Ti Fiber Metal Diffusion Bonding Process IQ/OQ/ PQ

VA 04-022OQ/PQ Addendum

VA 95-009 Equipment Qualification

VA 06-031Ti Fiber Metal Diffusion Bonding Process IQ/OQ/ PQ

VA 04-023OQ/PQ

VA 95-015Equipment Qualification


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7.0 Definitions and Symbols/ Acronyms

Definitions of terms, acronyms and symbols are included in the corresponding

qualification/ validation plan VA 11-116-VP. This section presents additional definitions

of terms in Table 2 and the symbols/ acronyms specific to this document in Table 3.

Table 2: Terms Definitions

Term Definition

Confidence

Level

The confidence or risk level is based on ideas encompassed under the

Central Limit Theorem. The key idea encompassed in the Central

Limit Theorem is that when a population is repeatedly sampled, the

average value of the attribute obtained by those samples is equal to thetrue population value. Furthermore, the values obtained by these

samples are distributed normally about the true value, with somesamples having a higher value and some obtaining a lower score thanthe true population value.

Indication A region of fiber metal which fails to completely bond to the surfaceof an implant. Indications for holography are depicted as solid black

regions on holography monitor.

ToleranceLimits

A set of limits between which we can expect to find any givenproportion of the population.

Diffusion

Bonding

A process by which metallurgical bonds are created at metal-to-metal

contact sites under heat and pressure.

Electron Beam

Welding

A process that produces coalescence of metals by heat obtained from aconcentrated beam of high velocity electrons impinging upon thesurfaces to be joined.

Fiber MetalA predetermined amount of formed wire compacted into a pre-determined volume of specified shape.

Holography

Holography is a technique for recording and reconstructing the

amplitude and phase distributions of a wave disturbance. It is widelyused as a method for three-dimensional optical image formation by

recording the pattern of interference between two mutually coherent

light beams (Laser Method).

The technique is accomplished by recording the pattern of interference

between coherent light reflected from the object of interest (object

beam), and light that comes directly from the same source (referencebeam).

Product Family A grouping of products based on similar design.

Tivanium Ti-6Al-4V Alloy


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Table 3: Acronyms and Symbols

Acronym/

SymbolAssociated Term

CP Commercially Pure

DB Diffusion Bonding

EBW Electron Beam Welding

GSOP Global Standard Operation Procedure

MIS Manufacturing/ Measuring Instruction Sheet

OCP Operating Control Procedure

SOP Standard Operation Procedure

ZES Zimmer Engineering Specification

ZMBV Zimmer Manufacturing BV, Ponce, PR

ZWI Zimmer Work Instruction

8.0 Verification Strategy

Product families manufactured in HIP BU cells 201/ 205 have been evaluated to identify

representative part numbers to be used for verification purposes. Evaluation process

included the list of product part numbers and design characteristics. Key aspects aredetailed below:

All product families have the same geometry at the diffusion bonding furnace cycle step.

Although different part numbers have different quantity of holes, such holes are made

after the diffusion bonding process. Therefore, its not considered as a variable.

Likewise, spiked shells includes three (3) spikes at the thermal furnace cycle. Therefore,

its not considered as a variable. Same materials and surface finish apply to all product

families.


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Sampling Size and Acceptance Cri teri a Determination and Justif ication

Samples will be withdrawn from available inventory of lots processed through all

currently approved router steps, as defined on production work orders, up to lastmachining operation after processing in the vacuum furnace.

NOTE: Sample/ test lots traceability must be clearly noted including lot number, part

number, and protocol and ITP number.

Specification limits for product cycles are established on ZES 2A-132:

Pore size and porosity, per ZES 2A-132:

The porous coating shall have an average volume porosity of 30-70%.

The porous coating shall have an average pore size between 100 and 1000microns.

NOTE: Product samples will be sent to the Analytical Testing Services (ATS) Laboratory

(ATS) in Warsaw, Indiana pore size, and porosity testing, using F-00517, Analytical

Testing ServicesMetals/Spec Test Request form.

Additional quality program requirements, not covered under this verification protocol,

include:

O2N2 monitoring coupons are analyzed at ZMBV, as per OCP 14.406-ZC.o Oxygen content plus nitrogen content shall not exceed 0.35 weight

percent, per ZES 2A-132.

Bonding integrity is evaluated on all diffusion bonded fiber metal coated

products using holography per ZES 4J-02, as required in ZES 2A-132. Penetrant inspection is performed on all spiked cups using ZES 4H-01, as

required in ZES 4L-02.

All products subjected to this qualification protocol meet requirements above specified.

8.1. Verification Execution and Sampling Strategy

For verification purposes, samples will be withdrawn from inventory lots manufactured at

ZMBV and collected from our Distribution Center at Warsaw. These samples were

processed under normal (nominal) operating conditions, as detailed in applicableproduction routers, MIS and operating procedures.

As per ANSI Z1.9 "Acceptance Variable Sampling Plan", Table A-2 below for a Total lotsize of 8342 ( available size of cup sizes) with general inspection Level II code letter L is

applied from Table B-3 with an AQL 1.0% , 75 parts must be sampled from Total

Population. (Refer to Appendix 5 for Instructions/Flowchart for proper use of ANSI Z1.9-2008)


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These parts will be sampled and tested per available cup size, for pore size and porosity.

Sample Selection Strategy consisted of grouping lots within families (Refer to Table 4

Inventory Lots Manufactured). ANSI 1.9 was applied per lot families and samplesdetermined to be pulled out from a random selected lot of each family (Pulled Qty by Part

Size).

The (75) seventy size parts were then selected from pulled samples. Refer to Table 6below (Sample size by Lot).

Table A-2: ANSI Z1.9 Variable Acceptance Sampling Strategy


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Table B-3: ANSI Z1.9 Variable Acceptance Sampling Strategy (Cont.)


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The following is a list of all part numbers and respective parts in stock. The total amount of parts

adds up to 8356 an this is considered the total lot size. In case the lot of 8356 parts is rejected anexamination of part numbers that resulted in outliers will be performed and further sampling with

individual lot numbers/work orders carried out as per ANSI Z1.9.

Table 4: Inventory Lots Manufactured

Part Number Lot # QTY SIZE Total per Family

00620003620 62001975 40 36

40

00620004220 62099620 20 42

20

00620004420 62099618 36 44

36

00620004620 62094940 36 46

00620004620 62099619 36 46

00620004620 62105171 36 46

108

00620004820 62105169 36 48

00620004820 62105170 36 48

00620004822 62091853 36 48

00620004822 62050952 35 48

00620004822 62091854 32 48

00620004822 62091855 36 48

00620004822 62094949 36 48

00620004822 62096961 33 48

00620004822 62096964 35 48

40640004822 62094937 18 48

40640004822 62099617 36 48

369

00620005020 62063920 33 50

00620005020 62063921 23 50

00620005020 62063922 35 50

00620005020 62076906 35 50

00620005020 62076905 13 50

00620005020 62096970 36 50

00620005020 62096972 36 50

00620005021 62094941 29 50

00620005022 62086036 63 50

00620005022 62086035 65 50

00620005022 62086032 67 50


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00620005022 62043448 32 50

00620005022 62050954 30 50

00620005022 62050955 29 5000620005022 62096965 35 50

00620005022 62096968 29 50

00620005022 62096966 33 50

00620005022 62096967 31 50

00620005022 62043449 29 50

00620005022 62065243 24 50

00620005022 62059673 36 50

00620005022 62099622 72 50

00620005022 62113212 72 50

00620005022 62114827 72 5000620005023 62076910 35 50

40620005020 62086026 50 50

40620005020 62113202 36 50

40620005022 62073487 36 50

40620005022 62113204 72 50

40620005023 62038312 35 50

40640005022 62072481 14 50

40640005022 62079953 36 50

1273

00620005220 62076902 67 52

00620005220 62010599 66 52

00620005220 62091842 71 52

00620005220 62043430 34 52

00620005220 62105161 72 52

00620005220 62105160 72 52

00620005222 62099623 68 52

00620005222 62086039 69 52

00620005222 62043451 70 52

00620005222 62086040 72 52

00620005222 62086041 68 52

00620005222 62099624 72 52

00620005222 62094944 72 52

00620005222 62091846 72 52

00620005222 62094945 72 52

00620005222 62096988 72 52

00620005222 62096989 72 52


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00620005222 62114822 72 52

00620005222 62114823 72 52

00620005222 62114824 72 5200620005223 62096993 36 52

00620005223 62052791 36 52

40620005220 62094933 72 52

40620005222 62050959 68 52

40620005223 62038316 36 52

40640005222 62070116 36 52

40640005222 62079951 36 52

1697

00620005420 62076899 67 54

00620005420 62079954 67 5400620005420 62105165 72 54

00620005420 62105166 72 54

00620005421 62043437 35 54

00620005422 62079962 70 54

00620005422 62079964 63 54

00620005422 62091844 70 54

00620005422 62094942 71 54

00620005422 62099649 71 54

00620005422 62099650 63 54

00620005422 62102516 68 5400620005422 62065248 60 54

00620005422 62094943 69 54

00620005422 62096987 72 54

00620005422 62096996 72 54

00620005422 62102514 72 54

00620005422 62102517 72 54

00620005422 62113213 72 54

00620005422 62118980 72 54

00620005423 62105176 36 54

00620005423 62001308 20 54

40620005422 62094935 72 54

40640005422 62070117 36 54

1514

00620005620 62094939 69 56

00620005620 62043432 67 56

00620005620 62043433 72 56


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00620005620 62105155 70 56

00620005620 62105156 72 56

00620005620 62113209 72 5600620005621 62043438 36 56

00620005622 62073492 66 56

00620005622 62091850 71 56

00620005622 62094946 72 56

00620005622 62094948 68 56

00620005622 62096990 60 56

00620005622 62091848 69 56

00620005622 62091849 66 56

00620005622 62099652 72 56

00620005622 62096999 72 5600620005622 62099651 72 56

00620005622 62113211 72 56

40620005622 62043443 72 56

40640005622 62070118 36 56

40640005622 62079950 36 56

40640005622 62079952 36 56

1398

00620005820 62076897 34 58

00620005820 62050960 32 58

00620005820 62102505 72 5800620005820 62105163 72 58

00620005820 62105162 72 58

00620005822 62060664 64 58

00620005822 62086031 68 58

00620005822 62046436 34 58

00620005822 62060663 57 58

00620005822 62091851 62 58

00620005822 62091852 70 58

00620005822 62086029 69 58

00620005822 62086030 67 58

00620005822 62113210 72 58

00620005822 62114818 72 58

40620005823 62038320 27 58

40640005822 62073488 36 58

00620005823 62105179 36 58

1016


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00620006020 62076904 35 60

00620006020 62076903 29 60

00620006020 62105158 36 6000620006020 62105159 36 60

00620006022 62086038 35 60

00620006022 62096991 34 60

00620006022 62102513 34 60

00620006022 62059676 32 60

00620006022 62065256 29 60

00620006022 62098945 35 60

00620006022 62046435 36 60

00620006022 62086037 36 60

00620006022 62098944 36 6000620006022 62098946 36 60

00620006022 62099621 36 60

00620006022 62102511 36 60

00620006022 62102512 36 60

587

00620006220 62076901 34 62

00620006220 62105157 36 62

00620006222 62094950 34 62

00620006222 62096992 36 62

00620006222 62109945 36 62176

00620006420 62102509 36 64

00620006420 62113207 36 64

00620006422 62103685 36 64

108

Totals 8342


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Table 5: Pulled Quantities by Part Size

PART SIZE Pulled Quantity**

36 4042 20

44 36

46 108

48 369

50 1273

52 1697

54 1514

56 1398

58 1016

60 58762 176

64 108

36 40

36 40

42 20

**Collected from a random lot selected in each family. Lot Number information will be documented

as part of the validation exercise.


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Table 6: Samples by Lot

QTY Part SIZE SAMPLE SIZE

Testing

Recommended

40 36 6 6

20 42 4 4

36 44 5 5

108 46 10 6

369 48 20 6

1273 50 50 6

1697 52 50 6

1514 54 50 61398 56 50 6

1016 58 35 6

587 60 35 6

176 62 15 6

108 64 10 6

40 36 6 6

8342 N/A 340 75

8.2. Change Management System and Product Disposition

HOLD Notification form (ZC-533) will be issued for each affected work order.Disposition of production lots on HOLD will be handled as per OCP 17.034-ZC

Nonconforming Material Report System, OCP 7.819-ZC Corrective and Preventive

Actions, and/ or OCP 17.147-ZC Planned Deviation Report System, as applicable.


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9.0 Roles and Responsibilities

Roles and Responsibilities

Deliverables Roles Responsibilities

Product

Disposition

Documentation

Project Owner:

Manufacturing (HIP BU

Manager or designee)QC Manager

Issue Hold Notice and planneddeviation forms, and include with work

orders affected by this study, as

applicable.

Protocol,Execution and

Report

Technical Support Services Issue protocol(s) and route for reviewand approval.

Assure all protocol discrepancies areproperly investigated and documented.

Issue report(s) and route for review andapproval.

Reviewers/ Approvers:

Manufacturing, IT, QC Lab,and QA Technical Services

Managers or designees

Review and approve protocol(s),discrepancy/ deviation forms, andsummary report(s).

Assure availability of requiredresources to complete the qualification/

validation study.

Assure applicable regulatory and

procedural requirements are covered.ATS, Biomechanical TestLab

Process samples and provide testresults report per applicable testmethods and procedures.

10.0 General Execution Procedure

10.1. Training Verification

Protocol execution and review should be performed by trained and qualified

individuals. Personnel executing ITPs should be trained in the applicable protocolsection(s) prior execution.

Verification of training/ certification of personnel involved in the execution of thisprotocol is documented in Pre-Requisite ITP-003.

10.2. Procedure

Objective evidence related to the execution of this qualification/ validation study isprovided by completing the data collection (ITPs/ test) forms included in this

protocol. Each data collection form includes:


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Test Number and Title: Unique identifiers for each ITP/ test form.

Requirement Specification: A space to document source for requirement/specification covered by the specific ITP/ test form.

Test Objective: A statement on the objective/ purpose of the specific ITP/ test.

Test Procedure: The actions and/or methodology required to execute thespecific ITP/ test to meet the objective.

Execution: A section (usually in table format) to document executioninformation. Expected and actual/ observed results columns are providedwhere applicable. For each ITP/ test step, actual/ observed results should

match the corresponding expected results.

Attachments: A space to indicate if attachments are included, and documentthe actual attachment number. Document N/A if no attachment is included.

Acceptance Criteria: Each ITP/ test specific acceptance criteria is included inthis section. NOTE: In case the ITP/ test is performed for baseline

information purposes, it will be indicated in this section. Discrepancy/ Deviation Report (DR No.): A space to document any

discrepancy/ deviation report related to the specific ITP/ test. DocumentN/A if no DR is included.

Comments: A space provided to document any pertinent additionalinformation specific to the ITP/ test form. Document N/A ifno comment is

needed.

ITP/ Test execution is completed by the executor(s) who sign/ date theRecorded By, Performed By or Verified By space(s) in the form.

Reviewed By and Date: A space provided to document test completion,including referenced attachments and DR forms, have been reviewed and are

satisfactorily documented and completed. The reviewer(s) must be a persondifferent than the executor.

10.3. Tests Acceptance Criteria

If all test steps within the ITP/ test form are satisfactorily completed, the ITP/ test is

accepted (Pass). If the result of any test step does not meet the expected result and/or testacceptance criteria, the ITP/ test is evaluated in order to determine whether the complete

ITP/ test pass or fails, and whether qualification activities should be suspended until

corrective actions are taken or not.

If qualification activities are suspended, the entire ITP/ test is failed and must be repeated

in its entirety. Refer to the Discrepancies/ Deviation Reports section below for detailedinstructions.

If the actual/ observed results do not match the expected results or acceptance criteria andthe test step can be immediately corrected, the corrective action is recorded in the

Comments section of the test case form. This action may be used only when there is an

explainable error in the test procedure, in the expected results or the acceptance criteria(e.g., sequencing of procedure, formatting, grammar, typographical errors, etc.).


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10.4. Discrepancies/ Deviation Reports (DR)

If any discrepancy or deviation to protocol requirements are found (e.g., actual/ observedresults do not match the expected results, and/or test acceptance criteria is not met) and

immediate corrective action cannot be taken as mentioned in the previous section,document the actual result, document Fail in the applicable Pass/Fail section for the

ITP/ test step. Initiate a Discrepancy/ Deviation Report (DR) describing the situation andinclude the DR No. in the DR Log, in sequential order.

An individual Discrepancy/ Deviation Report form should be completed for each protocol

related discrepancy or deviation. The failed ITP/ test or step should cross-reference to thecorresponding DR. Each section of the DR report form should be completed, including:

DR No.

ITP/ Test Number and Step

Description of the Incident

Whether suspension of qualification/ validation is required or not

Investigation and Corrective/ Preventive Actions

Conclusions

Whether DR is closed or not

Required signatures and dates in each section

In case additional space is required, a memo including the DR form sections may beissued, attached, and referenced in the actual DR form. Original DR forms, and any

supporting documentation, should be attached to the executed protocol.

Any needed changes to the equipment/ system/ process should be documented, as well as

required re-execution of the ITP/ test or step(s) affected by the discrepancy/ deviation.The extent of testing to be repeated will depend on the error and should be justified within

the DR report.In case a failed ITP/ test step is not required to be corrected and/or repeated, the decisionmust be justified in the DR report. In such case, the investigation/ conclusion should

clearly state whether the original failed ITP/ test is considered as satisfactorily completed

and accepted, including an appropriate rationale.After completion and review of the Investigation and Corrective/ Preventive Actions, and

Conclusions sections, the DR report should be submitted to QA/ TS Management for final

approval and disposition/ closure of the DR.

Upon satisfactory completion of the protocol tests, any open DRs are summarized,evaluated, and resolved prior to completing the corresponding qualification/ validation

report. In case, any DR needs to be kept open, it will be evaluated by QA/ TS

Management in order to determine whether the DR affects or not the outcome of thequalification/ validation. Final resolution should be included in this protocol Dispositionsection(s), as applicable.


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10.5. Attachments

All supporting documents and objective evidence pertaining to the execution of this

protocol should be included in an attachment, and logged in the Attachments Log.Attachments should be properly identified, including at least: protocol number, ITP/ test

number, quantity of pages, sign and date.


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11.0 Individual Test Protocols (ITPs)/ Tests Checklist

Verification TestingITP/

Test No.

(ITP-

XXX)

Item Description

Required

Test

(Y/N)

Comments

(If No selected, document

rationale)

ITP-001 Verification Sampling/ Monitoring Y

ITP-002Lot Acceptability/Rejection

Verification Test ResultsY


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Page ___ of ___

ITP-001 Verification Sampling/ Monitoring

Test Objective

Provide objective evidence that product manufactured (Trylogy cups)

manufactured as per current processes at ZMBV meet specifications, as

outlined in ZES 2A-132 per OCP 17.008-ZC Rev 19 for Pore size and

Porosity.

Test Procedure

Sample the required quantity of parts as established in this protocol.

Document the information required in below tables.

Send product samples to the Analytical Testing Services (ATS)Laboratory (ATS) in Warsaw, Indiana pore size, and porosity testing,

using F-00517, Analytical Testing ServicesMetals/Spec Test Request

form. Attach a copy of the filled form(s).

NOTE:Sample/ test lots traceability must be clearly noted including lot

number, part number, protocol, and ITP number.

Attachments Yes No If Yes, list attachment number[s]:

Comments:

Performed By/ Date Reviewed By/ Date

Make copies of this page as needed.


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Page 30 of 47

Page ___ of ___

ITP-001 Verification Sampling/ Monitoring

Product Type:

Lot No. Lot Size Cup

Size

P/Ns QTY Performed by: Date:

Total Quantity of Sampling/ Testing Parts:


Comments:

Performed By/ Date Reviewed By/ Date



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Page 31 of 47

Page ___ of ___

ITP-001 Verification Sampling/ Monitoring (CONT)

Acceptance

Criteria

Required Samples per Cup Size per Type were withdrawn: See Table 6

Samples are properly identified, including lot number, part number,protocol, and ITP number.

Samples were submitted to the Analytical Testing Services (ATS)Laboratory (ATS) in Warsaw, Indiana for pore size, and porosity

testing, and a copy of the corresponding form is attached F-00517,

Analytical Testing ServicesMetals/Spec Test Request form.

Information required in above tables was properly documented.

Acceptance

Criteria Met Pass FailIf Fail, refer to the corresponding Discrepancy/

Deviation Report (DR No.):


Comments:

Performed By/ Date Tables are Complete Reviewed By/ Date

Yes No



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Page ___ of ___

ITP-002 Lot Acceptance Criteria Verification Test Results

Test ObjectiveDocument and evaluate actual test results to provide objective evidencethat product manufactured at target (nominal) process parameters for theproduct cycles/ recipes meet required specifications for pore size and

porosity and access acceptability / rejection of lots per ANSI Z1.9

Test Procedure

Document and evaluate test results, calculate the required statistics, and

evaluate against acceptance criteria. Attach the corresponding Lab reports,

as well as verified/ signed print-outs of any spreadsheet used to record the

data and/or used for calculation purposes.


Comments:

Performed By/ Date Tables are Complete Reviewed By/ Date

Yes NoMake copies of this page as needed.


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Page 33 of 47

Page ___ of ___

ITP-002 Lot Acceptance Criteria Verification Test Results

Lot Acceptance

Criteria

Pore size and porosity lot evaluated as per Acceptance/RejectionCriteria ANSI Z1.9 Flowchart on page 19 of 48 on protocol.

AQL% Lot Size

Code- Letter &

Sample Size

(Inspection level

II)

M %

Nonconformance as

per ANSI Z1.9

(Accept P


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12.0 Verification Disposition

Item Yes or No Performed By / Date

All tests were completed?

Acceptance criteria met?

Any test still open?

If yes, explain below.

All discrepancies wereresolved satisfactorily,

approved and closed?

If not, explain below.


Comments:

________________________________________________________________________________________________________________________________________________

________________________________________________________________________

________________________________________________________________________________________________________________________________________________

________________________________________________________________________________________________________________________________________________

________________________________________________________________________

_________________________________ ______________________System Owner Date

_________________________________ ______________________

QA/ TS Date


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13.0 Protocol Attachments and Appendixes

Appendix 1: Protocol Signature Identification Sheet

Appendix 2a: Protocol Discrepancy/ Deviation Log

Appendix 2b: Protocol Discrepancy/ Deviation Report Form

Appendix 3a: Protocol Attachment Log

Appendix 3b: Protocol Attachment Identification Sheet

Appendix 4: Trilogy/ Acetabular Cup Product Families (Manufactured in Cell 201/205)

Appendix 5: ANSI Z 1.9 Instruction/Flowchart for Double Side Test.


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Page 36 of 47

Appendix 1

Protocol Signature Identification Sheet

The following is a record of each individual who signs or initials any page of this document in the

process of system validation.Page ___ of ___

Name (Print) Title Signature Initials Date


Reviewed by: ______________________________________Date: _____/_____/______


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Page 37 of 47

Appendix 2a

Protocol Discrepancy/ Deviation Log

Log all discrepancies/ deviations created during the execution of this protocol, and recorded on a

Discrepancy/ Deviation Report Form (DR).Page ____ of ____

Protocol

Discrepancy/

Deviation

Report No.

IncidentITP No.

and Step

Satisfactorily

Investigated

and Closed?

(Y/N)

Verified by/

Date


Reviewed by: _________________________ Date: _______


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Page 38 of 47

Appendix 2b

Protocol Discrepancy/ Deviation Report Form

DR No._____001___ Page __1_ of _1__

Section 1 Test Number and Step: ITP-002

Description of Incident:

VA-12-187-ST established that 75 samples of Trylogy cups would be tested for pore size andporosity to determine if they meet specifications as per ZES 2A-132. Two samples of cup size

048mm showed results below of the specification limits of 30% (29.2% and 29.5%) for porosity

and one for size 046mm (29.4%) porosity.

Performed By: Date:

Section 2 DR requires suspension of qualification/ validation: Yes / No: ___No__Investigation and Corrective/ Preventive Actions:

Based on ANSI Z1.9 (Variable Acceptance Plan) an X bar and s Chart were ran in Minitab for

porosity and pore size to assess outliers reflecting unsatisfactorily levels of porosity and pore(Refer to attachment 001 to Final Report for nonconformance of lots 048mm and 046mm). The

other 63 parts showed adherence to protocol requirements, Porosity and Pore size were then

assess to meet specification and all other lots released based on this results. Lots 62094940 size

46mm and lot 62094949 size 048mm that failed porosity criteria will be handled per OCP17.034-ZC Nonconforming Material Report system for proper disposition as per 62094949 NCR

2012-1048 and 62094940 NCR 2012-1047.

Performed By: Date:

Reviewed By: Date:

Section 3 Conclusions:

ANSI Z1.9 Acceptance for Variable Percent Non-Conforming was then applied to the 63 parts

samples (representing all cup sizes except 46mm and 48mm) resulting in acceptable levels forporosity and pore size. Therefore it is concluded that all lots from cup sizes except 46mm and

48mm meet porosity and pore size requirements as per ZES 2A-132 and will be disposed for

release.

Performed By: Date:

Reviewed By: Date:

Section 4 Is the DR closed? Yes/ No: ________

Quality Assurance Signature: Date:



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Page 39 of 47

Appendix 3a

Protocol Attachment Log

List all the documents used as objective evidence for the execution, specify number of pages and

related ITP(s). Each sheet of the attached documentation must be properly identified withvalidation document number, ITP number, and attachment page number.

Page ____ of ____

Attachment

NumberAttachment Title

Number of

Pages

Related

ITP(s)


Reviewed by: Date:


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Page 40 of 47

Appendix 3b

Protocol Attachment Identification Sheet

Attachment No: _____

No. of Pages: _____

Attachment for:

_______________________________________

_______________________________________

Compiled and Stamped/ Identified by: _____

Date: _______


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Page 41 of 47

Appendix 4

Trilogy/ Acetabular Cup Product Families (Manufactured in Cell 201/ 205)

CF CF Name Part Number CF CF Name Part Number SIZE

(mm)

DIAMETER

(inches)

FM

Compaction

Target

(grams)

FM

Compaction

Range (grams) DF Fixture

Fixture

Base Size

(inches)

40-6200-036-20 00-6200-036-20 36 1.388 5. 34 5. 04- 5. 54 25- 3500- 243- 36 3.0" x 3.0"

40-6200-038-20 00-6200-038-20 38 1.466 6. 02 5. 68- 6. 24 25- 3500- 243- 38 3.0" x 3.0"40-6200-040-20 00-6200-040-20 40 1.544 6. 74 6. 36- 6. 99 25- 3500- 243- 40 3.0" x 3.0"

40-6200-042-20 00-6200-042-20 42 1.624 7. 52 7. 10- 7. 81 25- 3500- 243- 42 3.0" x 3.0"

40-6200-044-20 00-6200-044-20 44 1.702 8. 32 7. 86- 8. 63 25- 3500- 243- 44 3.0" x 3.0"

40-6200-046-20 00-6200-046-20 46 1.782 9. 19 8. 67- 9. 53 25- 3500- 243- 46 3.0" x 3.0"

40-6200-048-20 00-6200-048-20 48 1.860 10.07 9.50-10.45 25-3500-243-48 3.5" x 3.5"

40-6200-050-20 00-6200-050-20 50 1.938 10.99 10.37-11.40 25-3500-243-50 3.5" x 3.5"

40-6200-052-20 00-6200-052-20 52 2.018 13.02 12.29-13.51 25-3500-243-52 3.5" x 3.5"

40-6200-054-20 00-6200-054-20 54 2.096 14.11 13.32-14.62 25-3500-243-54 3.5" x 3.5"

40-6200-056-20 00-6200-056-20 56 2.174 15.26 14.40-15.84 25-3500-243-56 3.5" x 3.5"

40-6200-058-20 00-6200-058-20 58 2.254 16.48 15.55-17.10 25-3500-243-58 3.5" x 3.5"

40-6200-060-20 00-6200-060-20 60 2.332 17.70 16.70-18.37 25-3500-243-60 4.0" x 4.0"

40-6200-062-20 00-6200-062-20 62 2.410 18.97 17.90-19.69 25-3500-243-62 4.0" x 4.0"

40-6200-064-20 00-6200-064-20 64 2.490 20.32 19.17-21.08 25-3500-243-64 4.0" x 4.0"

40-6200-066-20 00-6200-066-20 66 2.568 21.67 20.45-22.49 25-3500-243-66 4.0" x 4.0"

40-6200-068-20 00-6200-068-20 68 2.648 23.10 21.80-23.90 25-3500-243-68 4.0" x 4.0"

40-6200-070-20 00-6200-070-20 70 2.726 24.54 23.16-25.47 25-3500-243-70 4.0" x 4.0"

40-6200-072-20 00-6200-072-20 72 2.804 26.04 24.57-27.02 25-3500-243-72 4.0" x 4.0"

40-6200-074-20 00-6200-074-20 74 2.884 27.61 26.05-28.65 25-3500-243-74 4.0" x 4.0"

40-6200-076-20 00-6200-076-20 76 2.962 29.19 27.53-30.29 25-3500-243-76 4.0" x 4.0"

40-6200-078-20 00-6200-078-20 78 3.040 30.80 29.06-31.97 25-3500-243-78 4.0" x 4.0"

40-6200-080-20 00-6200-080-20 80 3.120 32.51 30.67-33.74 25-3500-243-80 4.0" x 4.0"

E31 HATCP Trilogy Mult i (-20) G04 Tr ilogy Mult i (-20)


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Page 42 of 47


(mm)

DIAMETER

(inches)

FM

Compaction

Target

(grams)

FM

Compaction


Fixture

Base Size

(inches)

00-6200-038-21 38 1.466 6.02 5.68- 6.24 25- 3500- 243-38 3.0" x 3.0"

40-6200-040-21 00-6200-040-21 40 1.544 6.74 6.36- 6.99 25- 3500- 243-40 3.0" x 3.0"

40-6200-042-21 00-6200-042-21 42 1.624 7.52 7.10- 7.81 25- 3500- 243-42 3.0" x 3.0"

40-6200-044-21 00-6200-044-21 44 1.702 8.32 7.86- 8.63 25- 3500- 243-44 3.0" x 3.0"

40-6200-046-21 00-6200-046-21 46 1.782 9.19 8.67- 9.53 25- 3500- 243-46 3.0" x 3.0"

40-6200-048-21 00-6200-048-21 48 1.860 10.07 9.50-10.45 25-3500-243-48 3.5" x 3.5"

40-6200-050-21 00-6200-050-21 50 1.938 10.99 10.37-11.40 25-3500-243-50 3.5" x 3.5"

40-6200-052-21 00-6200-052-21 52 2.018 13.02 12.29-13.51 25-3500-243-52 3.5" x 3.5"

40-6200-054-21 00-6200-054-21 54 2.096 14.11 13.32-14.62 25-3500-243-54 3.5" x 3.5"

40-6200-056-21 00-6200-056-21 56 2.174 15.26 14.40-15.84 25-3500-243-56 3.5" x 3.5"

40-6200-058-21 00-6200-058-21 58 2.254 16.48 15.55-17.10 25-3500-243-58 3.5" x 3.5"

40-6200-060-21 00-6200-060-21 60 2.332 17.70 16.70-18.37 25-3500-243-60 4.0" x 4.0"

40-6200-062-21 00-6200-062-21 62 2.410 18.97 17.90-19.69 25-3500-243-62 4.0" x 4.0"

40-6200-064-21 00-6200-064-21 64 2.490 20.32 19.17-21.08 25-3500-243-64 4.0" x 4.0"

40-6200-066-21 00-6200-066-21 66 2.568 21.67 20.45-22.49 25-3500-243-66 4.0" x 4.0"

40-6200-068-21 00-6200-068-21 68 2.648 23.10 21.80-23.90 25-3500-243-68 4.0" x 4.0"

40-6200-070-21 00-6200-070-21 70 2.726 24.54 23.16-25.47 25-3500-243-70 4.0" x 4.0"

40-6200-048-22 00-6200-048-22 48 1.860 10.07 9.50-10.45 25-3500-243-48 3.5" x 3.5"

40-6200-050-22 00-6200-050-22 50 1.938 10.99 10.37-11.40 25-3500-243-50 3.5" x 3.5"

40-6200-052-22 00-6200-052-22 52 2.018 13.02 12.29-13.51 25-3500-243-52 3.5" x 3.5"

40-6200-054-22 00-6200-054-22 54 2.096 14.11 13.32-14.62 25-3500-243-54 3.5" x 3.5"

40-6200-056-22 00-6200-056-22 56 2.174 15.26 14.40-15.84 25-3500-243-56 3.5" x 3.5"

40-6200-058-22 00-6200-058-22 58 2.254 16.48 15.55-17.10 25-3500-243-58 3.5" x 3.5"40-6200-060-22 00-6200-060-22 60 2.332 17.70 16.70-18.37 25-3500-243-60 4.0" x 4.0"

40-6200-062-22 00-6200-062-22 62 2.410 18.97 17.90-19.69 25-3500-243-62 4.0" x 4.0"

40-6200-064-22 00-6200-064-22 64 2.490 20.32 19.17-21.08 25-3500-243-64 4.0" x 4.0"

40-6200-066-22 00-6200-066-22 66 2.568 21.67 20.45-22.49 25-3500-243-66 4.0" x 4.0"

40-6200-068-22 00-6200-068-22 68 2.648 23.10 21.80-23.90 25-3500-243-68 4.0" x 4.0"

40-6200-070-22 00-6200-070-22 70 2.726 24.54 23.16-25.47 25-3500-243-70 4.0" x 4.0"

E32 HATCP Trilogy Solids (-21)

E33 HATCP Trilogy Cluster (-22) G09 Trilogy Cluster (-22)

G05 Trilogy Solids (-21)


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Page 43 of 47


(mm)

DIAMETER

(inches)

FM

Compaction

Target

(grams)

FM

Compaction


Fixture

Base Size

(inches)

40-6200-040-23 40 1.544 6.74 6.36- 6.99 25- 3500- 243-40 3.0" x 3.0"

40-6200-042-23 00-6200-042-23 42 1.624 7.52 7.10- 7.81 25- 3500- 243-42 3.0" x 3.0"

40-6200-044-23 00-6200-044-23 44 1.702 8.32 7.86- 8.63 25- 3500- 243-44 3.0" x 3.0"

40-6200-046-23 00-6200-046-23 46 1.782 9.19 8.67- 9.53 25- 3500- 243-46 3.0" x 3.0"

40-6200-048-23 00-6200-048-23 48 1.860 10.07 9.50-10.45 25-3500-243-48 3.5" x 3.5"

40-6200-050-23 00-6200-050-23 50 1.938 10.99 10.37-11.40 25-3500-243-50 3.5" x 3.5"

40-6200-052-23 00-6200-052-23 52 2.018 13.02 12.29-13.51 25-3500-243-52 3.5" x 3.5"

40-6200-054-23 00-6200-054-23 54 2.096 14.11 13.32-14.62 25-3500-243-54 3.5" x 3.5"

40-6200-056-23 00-6200-056-23 56 2.174 15.26 14.40-15.84 25-3500-243-56 3.5" x 3.5"

40-6200-058-23 00-6200-058-23 58 2.254 16.48 15.55-17.10 25-3500-243-58 3.5" x 3.5"

40-6200-060-23 00-6200-060-23 60 2.332 17.70 16.70-18.37 25-3500-243-60 4.0" x 4.0"

40-6200-062-23 00-6200-062-23 62 2.410 18.97 17.90-19.69 25-3500-243-62 4.0" x 4.0"

40-6200-064-23 00-6200-064-23 64 2.490 20.32 19.17-21.08 25-3500-243-64 4.0" x 4.0"

40-6200-066-23 00-6200-066-23 66 2.568 21.67 20.45-22.49 25-3500-243-66 4.0" x 4.0"

40-6200-068-23 00-6200-068-23 68 2.648 23.10 21.80-23.90 25-3500-243-68 4.0" x 4.0"

40-6200-070-23 00-6200-070-23 70 2.726 24.54 23.16-25.47 25-3500-243-70 4.0" x 4.0"

E34 HATCP Trilogy Spiked (-23)G07 Trilogy Spiked (-23)


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Page 44 of 47


(mm)

DIAMETER

(inches)

FM

Compaction

Target

(grams)

FM

Compaction


Fixture

Base Size

(inches)

40-6200-038-24 00-6200-038-24 6.02 5.68- 6.24 25- 3500- 243-38 3.0" x 3.0"

40-6200-040-24 00-6200-040-24 40 1.544 6.74 6.36- 6.99 25- 3500- 243-40 3.0" x 3.0"

40-6200-042-24 00-6200-042-24 42 1.624 7.52 7.10- 7.81 25- 3500- 243-42 3.0" x 3.0"

40-6200-044-24 00-6200-044-24 44 1.702 8.32 7.86- 8.63 25- 3500- 243-44 3.0" x 3.0"

40-6200-046-24 00-6200-046-24 46 1.782 9.19 8.67- 9.53 25- 3500- 243-46 3.0" x 3.0"

40-6200-048-24 00-6200-048-24 48 1.860 10.07 9.50-10.45 25-3500-243-48 3.5" x 3.5"

40-6200-050-24 00-6200-050-24 50 1.938 10.99 10.37-11.40 25-3500-243-50 3.5" x 3.5"

40-6200-052-24 00-6200-052-24 52 2.018 13.02 12.29-13.51 25-3500-243-52 3.5" x 3.5"

40-6200-054-24 00-6200-054-24 54 2.096 14.11 13.32-14.62 25-3500-243-54 3.5" x 3.5"

40-6200-056-24 00-6200-056-24 56 2.174 15.26 14.40-15.84 25-3500-243-56 3.5" x 3.5"

40-6200-058-24 00-6200-058-24 58 2.254 16.48 15.55-17.10 25-3500-243-58 3.5" x 3.5"

40-6200-060-24 00-6200-060-24 60 2.332 17.70 16.70-18.37 25-3500-243-60 4.0" x 4.0"

40-6200-062-24 00-6200-062-24 62 2.410 18.97 17.90-19.69 25-3500-243-62 4.0" x 4.0"

40-6200-064-24 00-6200-064-24 64 2.490 20.32 19.17-21.08 25-3500-243-64 4.0" x 4.0"

40-6200-066-24 00-6200-066-24 66 2.568 21.67 20.45-22.49 25-3500-243-66 4.0" x 4.0"

40-6200-068-24 00-6200-068-24 68 2.648 23.10 21.80-23.90 25-3500-243-68 4.0" x 4.0"

40-6200-070-24 00-6200-070-24 70 2.726 24.54 23.16-25.47 25-3500-243-70 4.0" x 4.0"

E35 HATCP Trilogy Uni Hole (-24) G13 Trilogy Uni Hole (-24)


45/47




Page 45 of 47


(mm)

DIAMETER

(inches)

FM

Compaction

Target

(grams)

FM

Compaction


Fixture

Base Size

(inches)

40-6400-048-20 48 1.860 10.07 9.50-10.45 25-3500-301-48 3.5" x 3.5"

40-6400-050-20 50 1.938 10.99 10.37-11.40 25-3500-301-50 3.5" x 3.5"

40-6400-052-20 52 2.018 13.02 12.29-13.51 25-3500-301-52 3.5" x 3.5"

40-6400-054-20 54 2.096 14.11 13.32-14.62 25-3500-301-54 3.5" x 3.5"

40-6400-056-20 56 2.174 15.26 14.40-15.84 25-3500-301-56 3.5" x 3.5"

40-6400-060-20 60 2.332 17.70 16.70-18.37 25-3500-301-60 4.0" x 4.0"

40-6400-062-20 62 2.410 18.97 17.90-19.69 25-3500-301-62 4.0" x 4.0"

40-6400-064-20 64 2.490 20.32 19.17-21.08 25-3500-301-64 4.0" x 4.0"

40-6400-066-20 66 2.568 21.67 20.45-22.49 25-3500-301-66 4.0" x 4.0"

40-6400-068-20 68 2.648 23.10 21.80-23.90 25-3500-301-68 4.0" x 4.0"

40-6400-070-20 70 2.726 24.54 23.16-25.47 25-3500-301-70 4.0" x 4.0"

40-6400-048-22 48 1.860 10.07 9.50-10.45 25-3500-301-48 3.5" x 3.5"

40-6400-050-22 50 1.938 10.99 10.37-11.40 25-3500-301-50 3.5" x 3.5"

40-6400-052-22 52 2.018 13.02 12.29-13.51 25-3500-301-52 3.5" x 3.5"

40-6400-054-22 54 2.096 14.11 13.32-14.62 25-3500-301-54 3.5" x 3.5"

40-6400-056-22 56 2.174 15.26 14.40-15.84 25-3500-301-56 3.5" x 3.5"

40-6400-058-22 58 2.254 16.48 15.55-17.10 25-3500-301-58 3.5" x 3.5"

40-6400-060-22 60 2.332 17.70 16.70-18.37 25-3500-301-60 4.0" x 4.0"

40-6400-062-22 62 2.410 18.97 17.90-19.69 25-3500-301-62 4.0" x 4.0"

40-6400-064-22 64 2.490 20.32 19.17-21.08 25-3500-301-64 4.0" x 4.0"

40-6400-066-22 66 2.568 21.67 20.45-22.49 25-3500-301-66 4.0" x 4.0"

40-6400-068-22 68 2.684 23.10 21.80-23.90 25-3500-301-68 4.0" x 4.0"

40-6400-070-22 70 2.726 24.54 23.16-25.47 25-3500-301-70 4.0" x 4.0"

E37 HATCP AB CUPS (40-64-20)

E38 HATCP AB CUPS (40-64-22)


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Page 46 of 47

Appendix 5

Instructions/Flowchart ANSI Z1.9-2008 (Double Sided Test)

B7. SUMMARY FOR OPERATION OFSAMPLING PLAN WHEN FORM 2 IS USED

The following steps summarize the procedures to be followed:

(1) Determine the sample size code letter from Table A-2by using the lot size and the inspection

level.

(2) Obtain plan from Master Table B-3 or B-4 by selecting the sampling size n and the

maximum allowable per-cent nonconforming M.

(3) Select at random the sample of n units from the lot inspect and record the measurement ofthe quality characteristic on each unit of the sample.

(4) Compute the sample mean Xand the estimate of lot standard deviation s.

(5) Compute the quality index (QU= (UX)/s) if an upper specification limit U is specified

for (QL= (XL)/s) if a lower specification limit L is specified

(6) Determine the estimated lot percent nonconforming PU or PL from Table B-5.

(7) If the estimated lot percent nonconforming PU or PL is equal to or less than the maximum

allowable percent non-conforming M, the lot meets the acceptability criterion; if PU or PL is

greater than M or if QU or QL is negative ,then the lot does not meet the acceptability criterion.


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Appendix 5

Instructions/Flowchart ANSI Z1.9-2008 (Double Sided Test)-Continued