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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

Matrix

Section

Supersedes -

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)

Test Plans (TP-01

Prepared by department no.: XXX

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


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


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.


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.


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 XXX

Author Validation Specialist

FGL QC Microbiology dept. Number XXX

Executor Validation specialist

XXX QC Microbiology dept. Number XXX

Review and Approval QC Manager

XXXXX Validation Manager dept. number Y

Review Approval Validation Manager

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.


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.


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.


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

Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00

Enclosure

Test Plans (TP-01) Training requirements The 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 to perform 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. no.

C/Q

Acceptance criteria

Acceptance criteria met: Yes / No

Attachment number (if applicable)*

Date/Init

1. N/A Q The person who carries through the tests have been trained/read in Validation Plan for Bag Sealer document number: 3245.Ed.1.

2. N/A Q The person who carries through the tests have been trained/read in Validation Master Plan document number: 3245.Ed.1.

3. N/A Q The person who carries through the tests have been trained/read in Qualification of Equipment and Facili-ties document number: 3245.Ed.1.

4. N/A Q

The person who carries through the tests have been trained in training courses Root causes analyses , non –conformities reports, good test and documenta-tion practice.

Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00 Enclosure

Test Plan (TP-02) Pre requisites

Test no.

Req. no.

C/Q

Acceptance criteria



Date/Init

5. N/A Q

Copy of Qualification Documents supplied by the Manufacturer to be attached to the executed Proto-col (Manual first page only).

6. N/A Q

Verify if the bag sealer is installed according to Sup-plier Installation Instructions in the Wash & Steriliza-tion Area.

7. N/A Q

Verify the status of calibration of bag sealer instru-ments. Calibration Certificate must be supplied by the Manufacturer and attached to the executed Proto-col.

8. N/A Q

Log book for the Bag sealer present during the instal-lation activities. Log book ( copy of first page ) at-tached to the executed Protocol.


Test Plan (TP-02) Pre requisites

Test no.

Req. no.

C/Q

Acceptance criteria



Date/Init

9. N/A Q

User Requirement specification for the Bag sealer reviewed and approved (copy of URS first page only attached to the executed Protocol).

10. N/A Q

Validation Plan for the Bag sealer reviewed and ap-proved (copy of VP first page only attached to the executed Protocol).

11. N/A Q Operation and Maintenance Instructions for the Bag sealer (draft only) to be attached to the executed Protocol.

Company Name IQ/OQ Qualification Protocol of Bag Sealer Tests Plans. Edition: 1.00

Enclosure

Test Plan (TP-03) Installation Qualification Tests.

Test no.

Req. no.

C/Q

Acceptance criteria



Date/Init

1. URS1 Q Equipment is marked with brand, model, ID- and TAG number.

Equipment ID/serial number:__________________________

Equipment TAG number:__________________________

Equipment Brand:_______________________________

Equipment Fabrication date:____________

2. URS2 Q System can function with AC 100-127V or AC 220-240V at 60 Hertz.

3. URS3 Q Display turns on when power is switch on.

4. URS4 Q

After power failure it must be possible to continue operating the bag sealer, without have to do a reinstallation of the pro-gram.

5. URS5 Q Printer and keyboard are plugging in to the bag sealer.

6. URS6 Q

Print quality: Bag sealer can switch between colour- and letter code.


Test Plan (TP-03) Installation Qualification tests.

Test no.

Req. no.

C/Q

Acceptance criteria



Date/Init

7. URS7 Q Keyboard works and the typed text is displayed cor-rectly on the display

8. URS8 Q Bag sealer complies with current local requirements concerning health and safety.

9. URS9 Q Temperature range of the Bag sealer: 80 – 220

o C.

10. URS10 Q

Copy of the calibration certificate must be attached to executed protocol (Refer to Test Plan (TP-02) Pre requisites).

Last calibration date________


Test Plan (TP-03) Installation Qualification tests.

Test no.

Req. no.

C/Q

Acceptance criteria



Date/Init

1. URS11 Q Calibration sticker of the temperature elements at-tached to the Bag sealer.

2. URS12 Q

Provide documented evidence that is possible to calibrate the temperature elements on the bag seal-ers.

3. URS13 Q

Give documented evidence that the design of the Bag Sealers comply with the general specification requirements.


Test Plan (TP-04) Operational Qualification tests.

Test no.

Req. no.

C/Q

Acceptance criteria



Date/Init

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.

3. URS16 Q Keyboard is working and the typed text is displayed correctly on the display.

4. URS17 Q Sealing quality: Bag sealer must produce a visual regularly weld, without damaging bag.

5. URS18 Q

The text typed in Bag sealer is printed on autoclave bag, and text include:

Date of sterilization;

Date of expiration;

Lot number;

User ID.

Date is stated in the correct format YYYY-MM-DD (YYYY= Year, MM= Month, DD= Day).

Company Name Qualification Protocol of Bag Sealer XXX Edition: 1.00 Page 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:


Conclusion:

Signed by:

Date: Init:

QA Approved by:

Date: Init:


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 number :

Description

Number of pages Initial & date

Signed by:

Date: Initial:

Company name

Qualification Protocol of Bag Sealer Edition: 1.00 Page 1 of 1

Change History

Edition Effective date Description of change Revised without changes

Date / Sign.

1.0 January 2011 Initial version

qualificationofbagsealerfinalpdf-1300522881089-phpapp02

Documents

bag sealer bag sealer

user requirements

gmp requirements

equipment number

system functional requirements

validation plan vpl

sterilization document

test plans tp