Kreation Handicraft

Performance Qualification
Equipment
Pouch filling and Sealing machine Page Number 1 of 8
Name
Protocol Revision
KH/PQ/001 00
Number Number
Equipment ID IA

Prepared by
Name/ Designation Signature Date

Vikal Sharma/Manager Quality Assurance

Remark:

Approved by (Validation Team)

Name Department Signature Date

 Kreation Handicraft
Performance Qualification
Equipment
Pouch filling and Sealing machine Page Number 2 of 8
Name
Protocol Revision
KH/PQ/001 00
Number Number
Equipment ID IA

Table of Contents

SERIAL TITLE
NUMBER

1.0 Objective

2.0 Scope

3.0 Responsibility

4.0 Procedure

5.0 Deviations and OOS if any

6.0 Reference

7.0 Attachments

8.0 Summary

9.0 Conclusion
 Kreation Handicraft
Performance Qualification
Equipment
Pouch filling and Sealing machine Page Number 3 of 8
Name
Protocol Revision
KH/PQ/001 00
Number Number
Equipment ID IA

1.0 Objective

The Objective of this protocol is to define the criteria for Performance Qualification of
Manufacturing Pouch Filling and Sealing machine. This protocol ensures the documented
evidence that the Pouch Filling and Sealing machine is designed as per Required specification /
Functional Specification and equipment meets the current Good manufacturing practice
(cGMP) requirements.

2.0 Scope

This protocol will define the test procedures, documentation references and
acceptance criteria, which will establish Pouch Filling and Sealing machine is designed
according to the requirements of Kreation Handicraft.

3.0 Responsibility
Preparation of this protocol-Maintenance department/Production/Quality Assurance

Review & execution of this protocol-QA, Engineering, Safety & Technical

Assembling all DQ data-Maintenance department/Production/Quality Assurance

Approval-Quality Assurance
Supplier-Nidan Packaging

4.0 Equipment Description:

Equipment Make / Model Equipment I.D. Working Capacity

Name Number
Pouch filling & Nidan Packaging / 60-65 stroke/minutes
Sealing Modle-NP-800L IA
Machine
 Kreation Handicraft
Performance Qualification
Equipment
Pouch filling and Sealing machine Page Number 4 of 8
Name
Protocol Revision
KH/PQ/001 00
Number Number
Equipment ID IA

5.0 Procedure

Description Procedure Observations

A. Functional Tests
Weight variation of Found OK
filled pouch.

Leakage Found OK
Sealing Found OK

Results for Pouch Weight

Weight of filled pouch

Nozzle N1 N2 N3 N4
Average
Maximum
Minimum

Weight of filled pouch

Nozzle N5 N6 N7 N8
Average
Maximum
Minimum

6.0 Deviation & Out of Specifition(s) if any:

______________________________________________________________________________
______________
 Kreation Handicraft
Performance Qualification
Equipment
Pouch filling and Sealing machine Page Number 5 of 8
Name
Protocol Revision
KH/PQ/001 00
Number Number
Equipment ID IA

7.0 References if any:

______________________________________________________________________________
________________

8.0 Attachments:

Attachment Details
Number

9.0 Summary:

______________________________________________________________________________
________________

9.0 Conclusion:

The Pouch filling and sealing machine (IA) has been tested and verified for
performance Qualification as per the Protocol.

The equipment stands Qualified / Disqualified as per the observations made

therein.

Hence it is concluded that equipment stands Qualifed / Not Qualified for

regular use.
Performance test is carried out as per following.
 Kreation Handicraft
Performance Qualification
Equipment
Pouch filling and Sealing machine Page Number 6 of 8
Name
Protocol Revision
KH/PQ/001 00
Number Number
Equipment ID IA

Serial Weight of Filled pouch/Strip Leakage

Number ( Horizontal/ Wrinkles in
Sealing Perforation
Vertical & Pin pouch
hole )

Weight of Filled Pouch/Strip in gram

N1 N2 N3 N4
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
Average

Maximum
Minimum
 Kreation Handicraft
Performance Qualification
Equipment
Pouch filling and Sealing machine Page Number 7 of 8
Name
Protocol Revision
KH/PQ/001 00
Number Number
Equipment ID IA

Serial Weight of Filled Pouch/Strip Leakage

Number ( Horizontal/ Wrinkles in
Sealing Perforation
Vertical & Pin pouch
hole )

Weight of Filled Pouch/Strip in gram

N5 N6 N7 N8
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22

23
24
Average

Maximum
 Kreation Handicraft
Performance Qualification
Equipment
Pouch filling and Sealing machine Page Number 8 of 8
Name
Protocol Revision
KH/PQ/001 00
Number Number
Equipment ID IA

Minimum