Equipment Validation Protocol TIQG106WLV-ROS / Technical Services / Engineering

FOR: The Installation Qualification of the Autopack Vertical Collation

Sleeve Wrapping system.

Equipment Plant No:

PREPARED BY: Autopack Co. Ltd. / SIGNATURE & DATE
REFERENCE: TIQG106WLV-ROS
PAGE 1 OF 4
Authorised:
Technical
Services/Manufacturing / Authorised:
Engineering / Authorised:
QA
Name: / Name: / Name:
Position: / Position: / Position:
Signature: / Signature: / Signature:
Date: / Date: / Date:

 Autopack Co Pty Ltd

Installation Qualification of the Autopack UnitTIQG106WLV-ROS

1. Purpose.

The purpose of this qualification is to verify theinstallation aspects of the Autopack Unit ______at ______.

This protocol defines the work required to provide documented evidence that the Autopack Unit installed in accordance with the manufacturer’s instructions and as per Customer’s standards, requirements and intended use and that the recommendations of the supplier of the equipment are suitably considered. The operation aspects of the Autopack Unit are covered in the operation qualification protocol TOQG106WLV-ROS

Performing this protocol will ensure that:

1.a.The operation of the equipment complies with the GAMP 4 and any legal or in-house standards in excess of the above.

1.b.The equipment operates as required by the equipment manufacturers (Autopack) and Ross Cosmetics Pty. Ltd.

1.c.All the necessary documentation and software discs are included in the equipment file and stored within the maintenance department together with the systems calibration and ancillary equipment.

This qualification forms part of the validation programme for the plant equipment and computer systems.

2. Scope.

The Autopack Unit being qualified consists of the following items:

2.a.Autopack 45WLV20FP Sleeve Wrapper S/N 15C4410

The qualification procedures within this document are to be carried out on the above items, located in the packing suite of the manufacturing facility at ______.

When this qualification is complete the equipment will be considered IQ validated and ready to use.

3. Equipment Description.

Cartons from ______Line are fed onto a side feeding conveyor of the Autopack Sleeve Wrapper. The cartonsgrouped into desired collation by means of successive strokes of lifter (selectable & adjustable within machine capacity).

Once ready the group is pushed forward and wrapped in a sleeve of polyethylene film. The now sleeved collation is transferred onto the tunnel conveyor. The bundle is then conveyed through the heated chamber of the Shrink Tunnel where the polyethylene sleeve shrinks to conform to the shape of the contents. Upon emerging from the heat chamber the film is cooled and shrinks further and binds containers firmly. The bundles are then convey onto the next process station towards to ______.

4. Installation Qualification Procedure.

This protocol defines the test procedures, documentation, references and acceptance criteria to be used to establish that the Autopack Unit has been installed properly, in accordance with manufacturer’s and Ross Cosmetics Pty. Ltd. specifications and intended use.

To verify the installation of the unit the following verifications must be carried out.

  • Identification Log: To register the names, signatures and initials of those people executing and reviewing this protocol.
  • Equipment Specification Verification To document the equipment details and installation quality.
  • Control System Installation Verification :(Hardware and Software).
  • Electrical Installation Verification: To verify the electrical aspects of the unit.
  • Pneumatic Installation Verification: To verify the pneumatic aspects of the unit.
  • Safety Audit: To ensure that the unit is safe to operate in its surrounding environment.
  • Training: To ensure that members of Ross Cosmetics Pty. Ltd. have been trained in the operation and maintenance of the unit.
  • Instrument Calibration: To verify that all critical instruments are calibrated / certified.
  • Documentation Verification: To verify that the relevant documents, drawings, manuals and SOPs are available for the unit.

The executed protocol will verify that the defined installation criteria have been satisfactorily addressed.

5. Acceptance Criteria

The acceptance criteria serve to insure that the information gathered during the execution of the Installation Qualification verifies the unit.

Each test/inspection has specific acceptance criteria that appear on each sheet where results are recorded.

The acceptance criteria for this protocol are as follows.

  1. All tests listed in the installation qualification procedure have been executed.
  2. The acceptance criteria for each individual test/inspection are met.
  3. All entries of data have been signed and dated by the person(s) carrying out the work.
  4. Each completed test sheet has been reviewed and signed.
  5. Any deviations that may have occurred during the qualification have been satisfactorily resolved.

The Installation Qualification Checksheets (Appendixes) will be completed in the field and will address the static aspects of the equipment with regard to GAMP, safety and documentation.

6. Responsibilities

Responsibility of the validation Department is as follows:

  • prepare this protocol for approval
  • compile a report summarizing the execution of the protocol and the results of testing that show the validation of this equipment to be complete

Responsibility of the Engineering Department is as follows:

  • review the protocol and the report
  • ensure protocol contain the necessary technical content required for the validation
  • approve the protocol and the report
  • provide the test equipment necessary to execute the protocol
  • execute the protocol and review executed protocol

Responsibility of the Technical Department is as follows:

  • review the protocol and the report
  • ensure protocol and report conform to GMP and GAMP guidelines
  • approve the protocol and the report

7. References.

The following are the references used in the preparation and execution of this validation protocol,

Validation Master Plan for The ______Packing Line.

Code of GAMP

Autopack’s OM and TM documents.

Document End

 Autopack Co Pty LtdPage 1 of 4

Installation Qualification of the Autopack UnitTIQG106WLV-ROS

Appendix

Appendix 1 / Identification Log
Appendix 2 / Equipment Specification Verification
Appendix 3 / Control System Installation Verification (Hardware and Software)
Appendix 4 / Electrical Installation Verification
Appendix 5 / Pneumatic Installation Verification
Appendix 6 / Safety Audit
Appendix 7 / Training
Appendix 8 / Documentation Verification
Appendix 9 / Instrument Calibration
Appendix 10 / Deviations and comments sheet.

APPENDIX 1Identification Log

Signature Identification.

To be signed by all executing this protocol

Name (BLOCK CAPITALS) / Position / Signature / Initials

Equipment Identification.

Log of equipment used in executing this protocol

Make / Model / Use / Serial Number / Calibration No.
AUTOPACK 45WLV20FP / Shrink Wrapper / 15C4410 / N/A

Comments:

Reviewed By: Date:

APPENDIX 2Equipment Specification Verification

Checksheet for Autopack Sleeve Wrapper.

Aspect / Detail / Verified (Yes/No) / Verified By / Date
Manufacturer / Autopack Co Ltd.
Model / 45WLV20FP
Serial number / 15C4410
Materials of construction / Stainless Steel
Conveyor Motors / 0 .37kw D71
415 V 1330 rpm
Unit Installation quality / Physically Secure
Clean
Adequate Clear Labeling
Emergency Stop Switches Fitted And Easily Accessible
Acceptance Criteria: Installed Equipment must conform to this Specification

Comments:

Reviewed By: Date:

APPENDIX 3Control System Installation Verification (Hardware and Software)

Autopack Programmable Logic Controller (PLC) Hardware

Aspect / Detail / Verified (Yes/No) / Verified By / Date
Manufacturer / Panasonic
Model / FP0R
Power Supply
Central Processing Unit (CPU) / FP0R-C14RS
Expansion Module / FP0-E16RS-A
Installation quality / Physically Secure
Clean and Dry
Adequate Clear Labeling
Acceptance Criteria: Installed Hardware must conform to this Specification

Autopack Programmable Logic Controller (PLC) Software

Aspect / Detail / Verified (Yes/No) / Verified By / Date
Operating system / Windows 95 (and above)
Application Software / FPWIN GR. From Matsushita Electric Works
Version / 2.90
Acceptance Criteria: Installed Software must conform to this Specification

Comments:

Reviewed By : Date:

APPENDIX 4Electrical Installation Verification

Checksheet for Autopack Unit.

Aspect / Detail / Verified (Yes/No) / Verified By / Date
Earthing / Grounding / Conductive inactive metal parts are grounded.
Earthing Connections are sufficiently tight.
Cabling / Electrical cabling is clearly labelled.
Terminations are firmly made.
Wiring is tidy and adequate trunking is used.
Cable entries into panels are glanded
Fusing / MCB’s / Fuses and MCB’s are correctly rated and functional
Mains Power / Unit connects to the mains power of the packing suite.
Acceptance Criteria: Installed Equipment must conform to this Specification

Comments:

Reviewed By: Date:

APPENDIX 5Pneumatic Installation Verification

Checksheet for Autopack Unit.

Aspect / Detail / Verified (Yes/No) / Verified By / Date
Tubing / Tubing is clearly labelled.
Connections are firmly made.
Tubing is tidy and leak tested.
Pressure Regulator / Main air regulator is correctly sized and functional
Mains Air / Unit connects to the mains air of the packing suite.
Supplied air pressure is sufficient for unit to function.
Acceptance Criteria: Installed Equipment must conform to this Specification

Comments:

Reviewed By: Date:

APPENDIX 6Safety Audit

Checksheet for Autopack Unit.

Description / Verified (Yes/No) / Verified By / Date
Verify that a Safety Audit has been carried out on the Autopack Unit (Sleeve Wrapper) and any outstanding issues have been resolved
Acceptance Criteria: Safety Audit has been carried out and copy of the report is attached to this checksheet

Comments:

Reviewed By: Date:

APPENDIX 7Training

Checksheet for Autopack Unit.

Description / Verified (Yes/No) / Verified By / Date
Verify that training records exist for Ross Cosmetics Pty. Ltd. personnel on the installation and maintenance of the Autopack Unit
Acceptance Criteria: Personnel have been trained in the installation and maintenance of the Autopack Unit and the training has been documented.

Comments:

Reviewed By : Date:

APPENDIX 8Documentation Verification

Checksheet for Autopack Unit.

Verify that the following documentation exists for the Installation of the Autopack Unit

Description / Document Title / Location / Verified By / Date
Drawing of Unit Configuration / in manual
Schematic Diagrams / In TM and soft copy
Pneumatic Diagrams / In TM and soft copy
Wiring Diagrams / In TM and soft copy
Operating Manual / soft copy
Technical Manual / soft copy
Acceptance Criteria: The above documents exist for and accurately represent the unit

Comments:

Reviewed By: Date:

APPENDIX 9Instrument Calibration

Record the calibration details of all critical instruments (if used) on the following form and attach copies of relevant certificates. This must be done pre and post operational qualification

Instrument Details / Instrument Range/Units / Cal. Cert. Ref. / Verified By / Date
Pre OQ
Post OQ

Comments:

Reviewed By : Date:

APPENDIX 10

Comments / Deviations Log

Comments / Deviations Report(s)

Comments / Deviations Log

comments / Deviation Log

Protocol Name: installation Qualification for the Autopack sleeve wrapper

Protocol Reference: PAC/EV01/P

Number / Description / Logged By & Date
001
002
003
004
005
006
007
008
009
010
011
012
013
014
015

comments / Deviation Report

Protocol Name: installation Qualification for the Autopack sleeve wrapper

Protocol Reference: TIQG106WLV-ROS

comments / Deviation number:

Comment/Deviation Description:

Conclusions/Actions:

Prepared By:Position:Date: __/___/_____

Reviewed By:Position:Date: __/___/_____

 Autopack Co Pty Ltd1