ValidationProtocolfo.. - Van der Stahl Scientific Inc

Transcript ValidationProtocolfo.. - Van der Stahl Scientific Inc

Important Notice

Van der Stahl Scientific, Inc. does not make any claims regarding the completeness or accuracy of the medical device packaging validation samples shared on our website. The scope of these shared validation documents is to show one customers approach to validation with our equipment. In no way are these documents shared as a ready made framework for your validation. This information is in place in order to add to the shared community of information surrounding sterile device packaging. If you are new to the medical device packaging process we urge you to work with a packaging consultant in order to be certain that your medical device packaging program is complete and compliant. Again, these are not ready made templates for your validation, they are only a sample of one customers approach to ISO 11607 and FDA compliance. Do not use any of these documents as a template, it is your responsibility to develop your own medical device packaging program with all of your unique product and manufacturing attributes. If you need further clarity regarding the limited scope please contact customer service at 800-550-3854.

Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process Validation # xxxx

Validation Protocol for Van Der Stahl OPL 300 Heat Sealer & Sterile Seal Forming Process Validation Management Team Approval

_________________________________________ _________________________________________ _________________________________________ Date: _____________________ Date: _____________________ Date: _____________________

C o n t e n t s

Validation Protocol…………………………………………………………………….…… Appendix A – IQ Requirements / Data Form…………………………………….….….

Appendix B – OQ Data Form….………………………………………………………….

Appendix C – PQ Data Form………………………………………………………..…….

Appendix D – Notebook Study Data……………………………….…………….……..

Appendix E – OPL 300-10 Operating Instructions.…………………………………..

Appendix F – Van Der Stahl Viu Criteria Board………………………………….…..

Appendix G – Package Data…………………………………………………………… Page Number 2 7 9 11 13 E-1 F-1 G-1

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Validation Protocol for Van Der Stahl Heat Sealer & Sterile Seal Forming Process 1.

Purpose & Scope

This document describes the validation protocol for the Van Der Stahl Heat Sealer, Model OPL-300-10, and sterile seal forming process for all preformed sterile packaging components used for terminally sterilized medical products produced at ABC Devices. The validation protocol is designed to comply with requirements of ISO 11607-2 and applicable portions of other standards as listed in section 2.

A notebook study was conducted prior to finalizing this protocol in an effort to approximate optimal conditions. Notebook study data is included in Appendix D. Based on the results the presumed optimal setting and target of this validation is 260 ° F, 1.5 seconds dwell, and cool temperature of 170 ° F. The target minimum peel test strength is 2.5 lb f /in.

References

2.1 ASTM F1886; 2009, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection – Appendix, Visual Seal Appearance Characteristics and Probable Causes 2.2

2.3

2.4

ASTM F88/F88m-09, Standard Test Method for Seal Strength of Flexible Barrier Materials ISO 11607-1; 2006, Packaging for Terminally Sterilized Medical Devices -- Requirements for Materials, Sterile Barrier Systems And Packaging Systems ISO 11607-2; 2006, Packaging for Terminally Sterilized Medical Devices – Validation Requirements for Forming, Sealing and Assembly Processes 2.5

2.6

2.7

ISO 13485; 2003, Section 7.5.2, Medical devices - Quality Management Systems - Requirements for Regulatory Purposes Van Der Stahl OPL 300-10 Operating Instructions Van Der Stahl Criteria Board for Heat Sealed Closure Systems

Responsibility

3.1

The Director of Quality Assurance shall be responsible for development and implementation of this protocol.

3.2

The validation management team shall be responsible for review and approval of this protocol and qualifications listed therein.

Equipment and Materials

4.1

Equipment: 4.1.1

Test samples will be inspected and tested with Van Der Stahl Peel Tester - Model PTT 100V Serial Number 11162012-0000021/096002B. The PTT-100V has been validated ) and is capable visual inspection per ASTM F1886 and peel testing per ASTM F88.

4.1.1.1 Peel Tester Settings: • Grip distance (Peel Org) = 1” • Peel Speed = 11.8 in/min • Test Mode = Auto

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process 4.2

4.3

4.4

4.1.2

4.1.3

4.1.4

• • Limit = Max Inspection Mode 1 Test samples will be prepared with Van Der Stahl Specimen Template Cutter in accordance with ASTM F88.

Test Samples will be inserted for testing with Van Der Stahl Specimen Setting Gauge.

Temperature and Humidity gauge used to record sample conditioning: XYZ Gauge.

Test Selection & Rationale 4.2.1

Tests selected include visual inspection per criteria in ASTM F1886, and peel testing per ASTM F88. These tests are listed as appropriate test methods for seal inspection and strength per ISO 11607-1, which is an FDA recognized consensus standard.

Materials: 4.3.1 Preformed pouches used in this validation consists of 48 gauge PET/.002 LDPE and Dupont Tyvek 1073B. Raw material for these pouches is supplied by XYZ Company, and by ABC Industries, Inc. These vendors are approved and monitored in accordance with SOP X.X, Purchasing and Supplier Monitoring Controls. Conformance of these materials to the requirements of ISO 11607-1 is listed in Appendix G. Material Selection & Rationale 4.4.1

Packaging component number P-024 (6 x 12 pouches) will be utilized for all testing. During the notebook study, lower peel strength values were recorded for the 6x12 pouch. Furthermore, the 6x12 pouch has the largest sealing area and represents greatest challenge for consistent seals. 4.4.2

Part Number 123 packaged in 6x12 pouches will be used for performance qualification testing. The pins shall be packaged at 4 pins per pouch in a loose manner allowing some limited movement within the pack. They represent the largest mass, weight, and package quantity of all sterile products. As such they have the greatest potential impact on seal integrity.

Sample Size and Preparation

5.1

5.2

5.3

5.4

For operational qualification, the experimental design requires a sample size of 13 for each treatment.

For pilot testing during the operational qualification 30 samples will be packaged, sealed, and tested as described in sections 6.3.2 - 6.3.6. For each performance qualification run 30 samples of part number 123 will be packaged, sealed, and tested as noted in section 6.3.2 - 6.3.6. Sample sizes are based on statistical analysis of samples from the notebook study, and requirements set forth in SOP 1.2.3.

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process 5.5

Samples shall be pre-labeled in per the following format: 5.5.1 Operational Qualification Example:

OQ-1-1

Performance Qualification Example:

PQ-1-1

OQ Treatment 1, Sample 1 Performance Qualification 1, Sample 1

Procedure

6.1

The validation will be comprised of three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). All test data shall be documented and stored with the final validation report. The validation management team shall progressively review and approve each qualification prior to advancing to the next phase.

6.2 Installation Qualification (IQ) 6.2.1

Installation qualification will be performed per the checklist and requirements listed in Appendix A. The criteria listed are based off manufacturer’s installation requirements.

6.2.2

The sealer control unit will be functionally tested during this phase. Output of OQ and PQ phases will demonstrate consistent and accurate controller functionality.

6.3 Operational Qualification (OQ) 6.3.1

The operational qualification designed experiment will be conducted using a 2ˆ See “Operating Instructions” page 9 for details on pressure.

3 full factorial with three factors: heating temperature, heat dwell, and cooling temperature. The pressure is determined by the thickness of the material used and is considered a constant. 4 5 6 7 8 1

Trials

(Randomized) H,L,L 2 3 L,L,L H,H,H L,H,L L,L,H L,H,H H,H,L H,L,H

Factor

Temperature Heat Dwell Cool Temp

Units

°F Seconds °F

Levels High Medium Low

260 2.0

200 235 1.5

175 210 1.0

150

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process 6.4

6.3.2

6.3.3

6.3.4

6.3.5

6.3.6

6.3.7

Sealer settings shall be adjusted as required and pre-labeled samples shall be sealed randomly along the heat sealing surface. Sealed samples shall be conditioned at: 72-75 ° F and 48-52% relative humidity for a minimum of 24 hours prior to testing (per ISO 11607-2).

Pre-sealed and conditioned samples shall be visually inspected with the VIU (PTT-100V) per the criteria listed in ASTM F1886. Van Der Stahl Viu Criteria Board shall be utilized for visual reference (Appendix F). Any seal defects will be recorded using the PTT-100V Visual Inspection Unit (VIU). Following each visual inspection, each sample shall be peel tested using the PTT-100V. Data shall be recorded.

6.3.5.1

All cut samples (per ASTM F-88) shall be sourced randomly along the length of the sealed edge of the pouch.

6.3.5.2

Tyvek side shall be inserted in the left pulling grip with the clear side in the right fixed grip.

6.3.5.3

Samples shall be tested using Technique A (unsupported tail) per ASTM F88.

Following each peel test, sample components shall be visually inspected for seal separation modes and interferences per ASTM F-88. Data shall be recorded.

6.3.6.1 Separation modes include: adhesive peel, cohesive peel, and de-lamination 6.3.6.2 Interferences include: material break, material break (remote), material elongation, and peel with elongation. 6.3.6.3 Interferences primarily impact strength readings for peel-able applications. This process is designed to weld seal the package. Therefore interferences shall be recorded but shall not be considered a defect.

Data from peel testing shall be statistically analyzed.

6.3.7.1 Factors having the greatest impact on seal strength will be identified and optimal settings will be established or confirmed. 6.3.7.2 If visual inspections reveal defective seals data shall be analyzed and a root cause established and recorded. For the purpose of this study, defectives shall be defined as seal defects listed in ASTM F1886.

6.3.8

A pilot test shall be conducted to confirm optimum settings.

6.3.8.1 Samples shall be tested in accordance with sections 6.3.2 - 6.3.6 above. The data will be analyzed and settings shall be confirmed and process capability index shall be calculated. 6.3.8.2 If adjustments are necessary, an additional pilot test and analysis shall be required prior to the performance testing phase.

Performance Qualification (PQ) 6.4.1

The Performance Qualification shall be conducted following successful completion of operational qualification.

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

7 8 9

6.4.2

6.4.3

Three lots part number 123 will be packaged and sealed at optimal settings established during operational qualification.

The sealing process will be challenged during the performance qualification as follows: 6.4.3.1 Multiple operators – at least two different operators shall conduct the sealing process.

6.4.4

6.4.5

6.4.3.2 Multiple shifts – Processing shall occur at morning, midday and evening.

Samples will be visually inspected and peel tested in accordance with sections 6.3.4 -6.3.6 above.

Data shall be statistically analyzed and the process performance index shall be calculated.

Acceptance Criteria

7.1

The validation shall be deemed acceptable upon successful completion of installation, operational, and performance qualifications as described herein, and conformance to applicable sections of standards referenced herein. 7.2

7.3

Successful operational and performance qualifications require a high degree of confidence that the process is capable of consistently producing continuous seals with an average max strength not less than 2.5 lb f /in with good adhesive transfer and no voids or gaps in the seal. A minimum process capability (Cpk) and performance capability (Ppk) index of 1.33 shall be required for acceptance. 7.4

7.5

A minimum 95% confidence level is required for seal strength equal to or exceeding 2.5 lb f /in. Attribute data (visual inspections) must be 100% conforming for the pilot and performance qualification runs. All acceptance requirements shall be documented in final the validation report.

7.6

Completion Activities

A final validation report is required for the completion of this study. The report shall include: • Confirmation of all requirements set forth in this protocol • Copies of test reports – IQ,OQ,PQ Data • Determination of validation acceptance based on acceptance criteria • Optimum operating settings for sealer • Summary of statistical data • Requirements for monitoring and revalidation

Records

This protocol, the associated final validation report, and all appendices therein shall be reviewed and approved per SOP 123 Control of documents. The approved copy shall be retained per SOP 123, Control of Records.

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix A Installation Qualification Data

Equipment Name

GENERAL INFORMATION

Van Der Stahl Impulse Sealer Serial Number(s) Model Number Equipment Location Equipment Description / Purpose Microcomputer-controlled impulse sealer for use in final sealing of medical packaging for terminal sterilization of medical devices.

Critical Process Parameters Process parameters include heat temperature, heat dwell time, and cool temperature. Pressure is constant based on the thickness of the material. Cool time is not adjustable. Adjustable parameters are controlled and monitored by user interface with the control unit.

INSTALLATION QUALIFICATION CHECKLIST

Inspection Damage Inspection MFG Equipment Tag Power Supply Temperature Humidity Control Unit Safety Criteria Free of dents, scratches, etc.?

Power cord free of cuts/ abrasions?

Heating element free of dents and dings?

Silicone rubber free of cuts or tears?

Teflon / Sarcon sheets cut or torn?

Visible / Legible? Verify Serial # 110 Volt Supply? On/Off Switch Operational?

41-104 ° F Humidity < 80% RH Digital Display Operational / Legible?

Temperature Adjustable?

Dwell Time Adjustable?

Auto Cycle Functional?

Abort Button Functional?

Pneumatic Switch Operational?

Circuit Breaker Installed?

Circuit Breaker Identified?

Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Yes/ No Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail Details / Comments Challenge pressure lever safety with foam block on minimal heat. Confirm lever returns to normal position. See Operators Manual. Pass Fail

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix A Installation Qualification Data (con’t)

FUNCTIONAL ASSESMENT

Seal 5 Tyvek Pouches at 260 ° F for 1.5 seconds dwell, and cool temperature of 170 ° F.

Ensure that seal width is approximately 3/8”. Pass Fail Ensure that sterile barrier system is completely formed. (Pouch is completely sealed) Ensure that seal is approximately ½” from end of pouch Pass Fail Pass Fail Ensure there are no channels, open seals, punctures, tears, de-lamination or separation.

Pass Fail Last Calibration

Calibration & Preventative Maintenance

Next Calibration Preventative Maintenance Documented?

Yes No Preventative Maintenance Current?

Yes No Operator Operator / Verifier Training

Operator / Verifier Information

Verifier Review of OPL-300 -10 Operating Instructions Training in use of Van Der Stahl PTT-100V Peel Tester Review of Validation Protocol

Comments CERTIFICATION

The data above has been reviewed and verified. The Installation Qualification of the OPL Heat Sealer and sterile package sealing process has been ACCEPTED (or) REJECTED Title Signature Date: Date: Date:

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix B Operational Qualification Datasheet

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix B

Con’t

Operational Qualification Results and Summary

Operator Operator / Verifier Training

Operator / Verifier Information

Verifier Review of OPL-300 -10 Operating Instructions Training in use of Van Der Stahl PTT-100V Peel Tester Review of Validation Protocol

Operational Qualification CERTIFICATION

The data above has been reviewed and verified. The Operational Qualification of the OPL Heat Sealer and sterile package seal forming process has been ACCEPTED (or) REJECTED Title Signature Date: Date: Date:

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix C Performance Qualification Datasheet

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix C

Con’t

Performance Qualification Results and Summary Operator / Verifier Information

Operator Operator Operator Operator Operator / Verifier Training Verifier Verifier Review of OPL-300 -10 Operating Instructions Training in use of Van Der Stahl PTT-100V Peel Tester Review of Validation Protocol QP-003 Training in SOP 7.5.2

Performance Qualification CERTIFICATION

The data above has been reviewed and verified. The Performance Qualification of the OPL Heat Sealer and sterile package sealing process has been ACCEPTED (or) REJECTED Director of Quality Assurance Director of Engineering Executive Vice President Date: Date: Date:

Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix D Notebook Study Data

1. Size vs. seal strength:

Validation # xxxx

Sterilized vs. unsterilized (seal strength): 3.

Sample Size Rationale: 4. Visual Inspection (ASTM F1886): 5. Minimum Peel Strength Rationale:

The target minimum peel test strength is 2.5 lbf/in. This minimum value is based on accelerated aging studies conducted by XYZ Industries which indicate initial unsterilized seal strength of 1.65 lbf/in. Peel test reports from XYZ indicate a minimum peel value of xyz lbf/in. Our xyz lbf/in minimum seal strength exceeds the preformed seal strength by approximately xyz%:

6. Attribute and Continuous Data:

Both attribute (visual) and continuous (peel strength) data are collected. The primary measureable output is seal strength. This data will be statistically analyzed. Zero defects are required for visual inspection.

7. Seal Integrity / Performance:

a. This validation is focused on equipment and seal forming process only.

Seal integrity over time and impact of product on seal integrity will be tested and validated in a separate package performance study to be conducted following this validation.

8. Seal Pressure

a. Seal pressure is constant based on the thickness of the material. Actual measured dimensions across random samples of several sizes of pouches were between .008” and .011”. Therefore the .0039-.0196 setting will be used. See page 9 of OPL Series Operating Instructions for more details.

Seal Separation Modes (ASTM F-88)

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process a.

Most samples tested separated by delamination. Some samples exhibited tearing in addition to delamination within the seal area. This is common for weld seals and will be considered common variation. See ASTM F88 section A1.1.1.

End of Notebook Study Notes

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix E Van Der Stahl OPL Series Operating Instructions

QP 10-003

Double click image above to view document.

Validation Protocol for Van Der Stahl Heat Sealer & Sealing Process Page E-1 Confidential

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix F Van Der Stahl Viu Criteria Board

QP 10-003

Double click image above to view document.

Validation Protocol for Van Der Stahl Heat Sealer & Sealing Process Page F-1 Confidential

Validation # xxxx Validation Protocol: Van Der Stahl Heat Sealer & Seal Forming Process

Appendix G Raw Material Conformance Data

QP 10-003 Validation Protocol for Van der Stahl Heat Sealer & Sealing Process Page G-1 Confidential

ValidationProtocolfo.. - Van der Stahl Scientific Inc

Transcript ValidationProtocolfo.. - Van der Stahl Scientific Inc

Important Notice

C o n t e n t s

OQ-1-1

PQ-1-1

Appendix A Installation Qualification Data

Appendix A Installation Qualification Data (con’t)

Appendix B Operational Qualification Datasheet

Appendix C Performance Qualification Datasheet

Appendix D Notebook Study Data

End of Notebook Study Notes

Appendix E Van Der Stahl OPL Series Operating Instructions

Appendix F Van Der Stahl Viu Criteria Board

Appendix G Raw Material Conformance Data

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