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Qualification Of Bag Sealer.Finalpdf.

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Installation and operational qualification for a bag sealer device.

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Qualification Of Bag Sealer.Finalpdf.

  1. 1. Company Name IQ/OQ Qualification Protocol of Bag Sealer Edition: 1.00 Page 1 of 13 IQ/OQ Qualification Protocol for Bag sealer Bag Sealer XXX Equipment Number:01234 Applies to Supersedes - Matrix Section Copy no. - References : User Requirement for Bags sealers used in Washing and Sterilization areas. Doc. Number XXX. Validation Plan (VPL) – Washing and Sterilization Document number: XXXX. Monthly calibration check on Bag Sealer. Doc. Number: XXXXX Operational & Maintenance Instructions Bag Sealer. Doc. Number : XXXX Enclosures : Tests Plan (PT01) – Training Requirements (page 1 0f 3) Tests Plan (PT01) –Installation Requirements (page 1,2 and 3 0f 4) Tests Plan (PT03) – Operational Requirements (page 4 0f 4) Prepared by department no.: XXXTP-01 Validation Improvement Specialist (date) Fatima Grangeiro Landim (FGL) Reviewed and Approved by: Quality Control Labs Manager (date) QC Manager Validation Manager (dato) Validation Manager Quality Assurance Manager (date) Quality Assurance Officer
  2. 2. Company NameIQ/OQ Qualification Protocol of Bag SealerEdition: 1.00Page 2 of 13 Table of Contents 1 Purpose and Scope..............................................................................3 1.1 Out of Scope .................................................................................3 2 Responsibilities ....................................................................................3 3 Definitions and Abbreviations ............................................................... 5 4 Equipment Description .........................................................................5 4.1 System Functional Requirements..................................................6 4.2 Autoclaves bags ............................................................................7 4.3 System technical data ...................................................................7 5 Test Plans Order ..................................................................................7 6 Conclusion ........................................................................................... 8 7 Test Plans ............................................................................................ 8 8 Deviation (non-conformance) Report....................................................1 9 Attachments .........................................................................................3
  3. 3. Company NameIQ/OQ Qualification Protocol of Bag SealerEdition: 1.00Page 3 of 13 1 Purpose and Scope The purpose of this Qualification protocol is establishing documented evidence that the Bag sealer is installed and operated in accordance with User Requirements and GMP requirements. This Qualification Protocol includes compilation of data and defines the test plans/checks to be performed to verify that the Bag Sealer is installed and operates as specified. The highest goal of the Bag sealer qualification activities is to make sure that all the packaging materials (bags/barrier system integrity) is attained and will remain so until opened by the users of sterile materials (e.g. loads such as: utensils, gowning, glassware etc.) The scope of this document covers all areas of the IQ/OQ qualification to be accom- plished to ensure functionality of the Bag Sealer. 1.1 Out of Scope The scope of work upon which the testing and inspection for the Bag sealer docu- mented in this qualification protocol, will not cover any performance verification test- ing. Performance verification tests for the system will be covered in a independent Performance Qualification Protocol.  Calibration of temperature element on the bag sealer (attach calibration cer- tificate of the vendor);  Calibration of force for the Bag sealer (performed each time the device is turned on);  Calibration date and results will be document in a Test plan;  Checking whether sealing of many bags in a row will affect the quality of the sealing;  2 Responsibilities It is the responsibility of the author of this Protocol  That the contents of the Qualification protocol are complete and unambiguous;  To ensure consistency between the objective of the protocol and the actual con- tents.  That the technical contents and methods are correct so that the protocol is ade- quate for the specified validation.
  4. 4. Company NameIQ/OQ Qualification Protocol of Bag SealerEdition: 1.00Page 4 of 13  Any documentation referent to the Bag sealer is correct (to eg. part numbers, batch numbers and documents). It is the responsibility of end user (or customer)  Agrees with the contents, method and acceptance criteria established in the Qualification Protocol;  Agrees that any actions chosen to remedy non-conformities are acceptable and must be fully documented;  To review drafted Protocol and to ensure consistency between the objective of the protocol and the actual contents.  To review the final Qualification Report for this Qualification Protocol; for l and report.  To review all non-conformities (if applicable) for this Qualification Protocol. It is the responsibility of the data reviewer  Verification that the data and any comments in the test plan are registered according to “Good Documentation practice”.  Verification that the test results conform to acceptance criteria and appropri- ate non-conformance reports have been generated, approved and closed (if applicable);  Signing of test plans after test completion – all testes plans being reviewed must be signed and dated by reviewer. It is the responsibility of the test executor  Executing the test following in accordance with pre-approved test plans;  Registration of observations and collection of data in accordance with “Good Documentation Practice”;  Signing of test plans after test completion (all tests must be signed and dated in the time of the execution);  Documenting all non-conformities and signing for it;  If re–test is required (after non-conformities), the non-conformities report must be signed again by the executor. It is the responsibility of Validation and QA  To ensure compliance with current procedures for validation.  That documents and data meet the requirements for validation documents, cGMP requirements and registration-related requirements.  To ensure consistency between the objective of the protocol and the actual contents.  To ensure correct transfer of requirements from the URS/FRS to test plan.  To ensure correct choice of test plans.
  5. 5. Company NameIQ/OQ Qualification Protocol of Bag SealerEdition: 1.00Page 5 of 13  To review, comment (if applicable) and approve final protocol and report;  Review and approval of all non-conformities; Initials Department Responsibility Title FGL QC Microbiology dept. Number Author Validation Specialist XXX FGL QC Microbiology dept. Number Executor Validation specialist XXX XXX QC Microbiology dept. Number Review and Approval QC Manager XXX XXXXX Validation Manager dept. Review Approval Validation Manager number Y XXX QA dept. Number XXX Review Approval QA Officer 3 Definitions and Abbreviations Abbreviation Full text/ Explanation QA Quality Assurance CR Change Request TP Qualification Test Plan Ph. Eur. European Pharmacopoeia CCA Critical Component Assessment VP Validation Plan IQ/OQ IQ and OQ Qualification PQ Performance Qualification URS User Requirement Specification USP U.S. Pharmacopoeia 4 Equipment Description The Bag sealer device is used for sealing of autoclave bags made of paper and plastic multi layer foil supplied by the Qualified supplier BVCT.S.A. The sealing device (Bag sealer) accommodates every material and its design guar- antees an optimum sealing security and seal seam strength.
  6. 6. Company NameIQ/OQ Qualification Protocol of Bag SealerEdition: 1.00Page 6 of 13 Tag Number for the Bag sealer is 968ADC.It is located in room 65, building 9. 4.1 System Functional Requirements The bag sealer (sealing device) contains two teflon-coated heating elements, which are mounted on springs. Coated heating elements converts electricity into heat through the process of joule heating. The autoclave bags are then inserted in the device with the plastic side upwards. During the sealing process, the heated sides of the autoclave bags should be pressed against each other by a small roller. Refer to picture below: Sealing of autoclave bags. After the sealing process is completed, a small printer connected to the Bag sealer has the function of printing out the following data: 1. Date of sealing; 2. Expiration date; 3. ID user; 4. Batch number of the sealed material; 5. Autoclave number (information entered before in the sealing device by operator); 6. Process parameter (temperature, contact pressure). 7. Bag sealer serial number. When the autoclave bag is inserted in bag sealer (sealing device) a conveyor belt is activated by a mechanical sensor. The sealed autoclave bag is then taken out on the right side of the bag sealer. If a new autoclave bag is not inserted within 30 seconds, the conveyor belt will automatically stop. The temperature of the heating elements is regulated by use of a microprocessor which continuously regulates the temperature up and down with respect to the set point.
  7. 7. Company NameIQ/OQ Qualification Protocol of Bag SealerEdition: 1.00Page 7 of 13 An optimum seal seam can be guaranteed if such critical parameters as sealing temperature and pressure are correctly set and adjusted to the material to be sealed. 4.2 Autoclaves bags Types Dimensions Steribag XXX Bags 30cm X 50cm Steribag YYYBags 20cm X 40cm Steribag TTT.bags 15cm X 20cm 4.3 System technical data Technical data Description Type of Device Bag sealer Process course Automatic/reproducible Sealing speed/time 10 m/min (33 ft./min) Sealing temperature Max. 220°C (max. 428°F) Seal width 12 mm Contact pressure 100 N* (1 Pa = 1 N/m²)/ Sealing distance from edge 5 - 30 mm Tolerance of sealing temperature ± 2% 5 Test Plans Order The test plans must describe all prerequisites to be executed and documented in this Quali- fication protocol. The objective of t ordering the tests plans is that some tests require, that certain prerequi- sites have been fulfilled, before the test can be performed with a valid result. One such prerequisite could be that another test plan has already been performed/ docu- mented and approved. Test plans have been ordered in the sequence in which they must be performed. A test plan with a given “Test plan order” number should not be performed before the ones with a lower numbers. Some test plans do not have any bindings to each other and can be performed simultane- ously. Such test plans have been given the same ordering number. Before starting a test, the Test Responsible must simply check this table, and verify that all test plans with a lower ordering number have been approved.
  8. 8. Company NameIQ/OQ Qualification Protocol of Bag SealerEdition: 1.00Page 8 of 13 Test plan order TP No. Title 1 TP-01 Training Requirements 2 TP-02 Prerequisites 3 TP-03 Installation Qualification tests. 4 TP-04 Operational Qualification tests. 6 Conclusion The IQ/OQ qualification Protocol is completed when all tests are carried out. Any validation non-conformity records are approved and closed by the qualified person- nel described in the Responsibility matrix section 2 of this protocol. The final Qualification Report must been prepared describing the test sequence of events its outcomes and any non-conformities (if applicable).The qualification report must include a comprehensive explanation of all test results and a final conclusion certifying that the device it is ready for production use. 7 Test Plans
  9. 9. Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00 EnclosureTest Plans (TP-01) Training requirementsThe purpose of the test is to verify that each person who will perform the IQ/OQ tests has received training to have enough knowledge and skills toperform all the tests approved in this Qualification Protocol.* Copy of the training record for the person executing this Protocol must be attached to the executed Protocol. Test no. Req. C/Q Acceptance criteria Acceptance Attachment Date/Init no. criteria met: number (if Yes / No applicable)* The person who carries through the tests have been 1. N/A Q trained/read in Validation Plan for Bag Sealer document number: 3245.Ed.1. The person who carries through the tests have been 2. N/A Q trained/read in Validation Master Plan document number: 3245.Ed.1. The person who carries through the tests have been 3. N/A Q trained/read in Qualification of Equipment and Facili- ties document number: 3245.Ed.1. The person who carries through the tests have been trained in training courses Root causes analyses , 4. N/A Q non –conformities reports, good test and documenta- tion practice.
  10. 10. Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00 EnclosureTest Plan (TP-02) Pre requisitesTest no. Req. C/Q Acceptance criteria Acceptance Attachment Date/Init no. criteria met: number (if Yes / No applicable)* Copy of Qualification Documents supplied by the 5. N/A Q Manufacturer to be attached to the executed Proto- col (Manual first page only). Verify if the bag sealer is installed according to Sup- 6. N/A Q plier Installation Instructions in the Wash & Steriliza- tion Area. Verify the status of calibration of bag sealer instru- ments. Calibration Certificate must be supplied by the 7. N/A Q Manufacturer and attached to the executed Proto- col. Log book for the Bag sealer present during the instal- 8. N/A Q lation activities. Log book ( copy of first page ) at- tached to the executed Protocol.
  11. 11. Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00 EnclosureTest Plan (TP-02) Pre requisites Test no. Req. C/Q Acceptance criteria Acceptance Attachment Date/Init no. criteria met: number (if Yes / No applicable)* User Requirement specification for the Bag sealer 9. N/A Q reviewed and approved (copy of URS first page only attached to the executed Protocol). Validation Plan for the Bag sealer reviewed and ap- 10. N/A Q proved (copy of VP first page only attached to the executed Protocol). Operation and Maintenance Instructions for the Bag 11. N/A Q sealer (draft only) to be attached to the executed Protocol.
  12. 12. Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00 EnclosureTest Plan (TP-03) Installation Qualification Tests. Test Req. no. C/Q Acceptance criteria Acceptance criteria met: Yes / No Attachment Date/Init no. number (if applicable)* Equipment ID/serial number:__________________________ Equipment is marked with Equipment TAG number:__________________________ 1. URS1 Q brand, model, ID- and TAG number. Equipment Brand:_______________________________ Equipment Fabrication date:____________ System can function with AC 2. URS2 Q 100-127V or AC 220-240V at 60 Hertz. Display turns on when power 3. URS3 Q is switch on. After power failure it must be possible to continue operating 4. URS4 Q the bag sealer, without have to do a reinstallation of the pro- gram. Printer and keyboard are 5. URS5 Q plugging in to the bag sealer. Print quality: Bag sealer can switch between colour- and 6. URS6 Q letter code.
  13. 13. Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00 EnclosureTest Plan (TP-03) Installation Qualification tests. Test no. Req. C/Q Acceptance criteria Acceptance Attachment Date/Init no. criteria met: number (if Yes / No applicable)* Keyboard works and the typed text is displayed cor- 7. URS7 Q rectly on the display Bag sealer complies with current local requirements 8. URS8 Q concerning health and safety. o Temperature range of the Bag sealer: 80 – 220 C. 9. URS9 Q Copy of the calibration certificate must be attached to executed protocol (Refer to Test Plan (TP-02) Pre Last calibration 10. URS10 Q requisites). date________
  14. 14. Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00 EnclosureTest Plan (TP-03) Installation Qualification tests. Test no. Req. C/Q Acceptance criteria Acceptance Attachment Date/Init no. criteria met: number (if Yes / No applicable)* Calibration sticker of the temperature elements at- 1. URS11 Q tached to the Bag sealer. Provide documented evidence that is possible to 2. URS12 Q calibrate the temperature elements on the bag seal- ers. Give documented evidence that the design of the 3. URS13 Q Bag Sealers comply with the general specification requirements.
  15. 15. Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00 EnclosureTest Plan (TP-04) Operational Qualification tests. Test no. Req. C/Q Acceptance criteria Acceptance Attachment Date/Init no. criteria met: number (if Yes / No applicable)* 1. URS14 Q Display turns on when power is switch on. 2. URS15 Q Bag sealer must automatically pulls the paper bag through the device. Keyboard is working and the typed text is displayed 3. URS16 Q correctly on the display. Sealing quality: Bag sealer must produce a visual 4. URS17 Q regularly weld, without damaging bag. The text typed in Bag sealer is printed on autoclave bag, and text include:  Date of sterilization;  Date of expiration; 5. URS18 Q  Lot number;  User ID.  Date is stated in the correct format YYYY- MM-DD (YYYY= Year, MM= Month, DD= Day).
  16. 16. Company NameQualification Protocol of Bag Sealer XXXEdition: 1.00Page 1 of 3 8 Deviation (non-conformance) Report Non–conformance/Deviation Report Protocol number : Number of deviation: Deviation description : Signed by: Date: Init: Reason and proposal of corrective action: Signed by: Date: Init:
  17. 17. Company NameQualification Protocol of Bag Sealer XXXEdition: 1.00Page 2 of 3 Conclusion: Signed by: Date: Init: QA Approved by: Date: Init:
  18. 18. Company NameQualification Protocol of Bag Sealer XXXEdition: 1.00Page 3 of 3 9 Attachments Record the details of each attachment made to this executed protocol. Each attachment must be signed and dated, and the pages numbered un- der the page X of Y convention (including Protocol number): Attachment Initial & date Number of pages number : Description Signed by: Date: Initial:
  19. 19. Company nameQualification Protocol of Bag SealerEdition: 1.00Page 1 of 1 Change HistoryEdition Effective date Description of change Revised without changes Date / Sign.1.0 January 2011 Initial version

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