Qualification Of Bag Sealer.Finalpdf.

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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.: XXX
TP-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

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Edition: 1.00
Page 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

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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.

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 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.

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 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.

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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.

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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.

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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

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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. 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.
2. N/A Q trained/read in Validation Master Plan document
number: 3245.Ed.1.
3. N/A Q trained/read in Qualification of Equipment and Facili-
ties document number: 3245.Ed.1.
trained in training courses Root causes analyses ,
4. N/A Q
non –conformities reports, good test and documenta-
tion practice.

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Enclosure

Test Plan (TP-02) Pre requisites

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.

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Enclosure

Test Plan (TP-02) Pre requisites

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.

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Enclosure

Test 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.

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Enclosure

Test Plan (TP-03) Installation Qualification tests.

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________

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Enclosure

Test Plan (TP-03) Installation Qualification tests.

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.

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Enclosure

Test Plan (TP-04) Operational Qualification tests.

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).

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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:


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Conclusion:


QA Approved by: Date: Init:

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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:

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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

Qualification Of Bag Sealer.Finalpdf.

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