Performance Qualification of Automatic Capsule Filling Machine

Published on: April 16, 2024 by Naresh Bhakar

Performance Qualification of Automatic Capsule Filling Machine defines the test procedures,
documentation, references, and acceptance criteria to establish that the performance of the
equipment shall meet the predetermined acceptance criteria.

SERIAL NO. ITEM DESCRIPTION

1.0 PROTOCOL APPROVAL

2.0 OVERVIEW:

2.1 Objective

2.2 Purpose

2.3 Scope

2.4 Responsibility
2.5 Execution Team

3.0 GENERAL CONSIDERATION/PREREQUISITE

4.0 REVALIDATION CRITERIA

5.0 PERFORMANCE QUALIFICATION PROCEDURE

5.1 Methodology

6.0 ENVIRONMENTAL CONDITION

7.0 CAPSULES PARAMETERS

7.1 In-process checks

7.2 Uniformity of weight

8.0 DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S)

9.0 Annexure (s)

10.0 PERFORMANCE QUALIFICATION FINAL REPORT

10.1 Summary

10.2 Conclusion

10.3 Final report approval

1.0 PROTOCOL APPROVAL:

This performance qualification protocol for the Automatic capsule filling machine has been
reviewed and approved by the following persons:

FUNCTION NAME DEPARTMENT SIGNATURE DATE

PREPARED BY QUALITY ASSURANCE

REVIEWED BY PRODUCTION
REVIEWED BY QUALITY CONTROL

APPROVED BY QUALITY ASSURANCE

2.0 OVERVIEW :

2.
OBJECTIVE:
1

The objective of Automatic filling capsules PQ is to develop and execute, the document verification of all aspects of
the equipment that can affect product quality. To make an impact assessment of the critical components of the
equipment on the material To establish, check, and document the performance of equipment in the
established/predetermined operating ranges.

2.2 PURPOSE:

The purpose of this protocol is to verify that the equipment produces the desired output. Performance qualification of
the equipment is planned after successfully completing the installation Qualification and operational qualification of
the automatic capsule-filling machine. The performance of the Automatic capsule-filling machine is verified by
charging the hopper with the blend and verification of physical parameters of the tablets. The filled capsule was
collected at different stocks and varying other parameters.
2.3 SCOPE:

The protocol shall define the test procedures, documentation, references, and acceptance criteria to establish that the
performance of the equipment shall meet the predetermined acceptance criteria. The Scope of this protocol is limited
to the performance qualification of the Automatic capsule filling machine at XYZ Pharmaceuticals, and the Capsule
filling area. Once the performance qualification of the Automatic capsule filling machine has been completed
successfully, the equipment shall be released for the production trial

2.4 RESPONSIBILITY:

The following shall be responsible;

Quality assurance officer/Executive – For Preparation of Protocol /Execution.
Production Head – For execution support.
Quality Control head – To analyze the process.
Quality Assurance Head – For adequacy and final approval.

2.5 EXECUTION TEAM:

The execution team is responsible for the execution of performance qualification of Automatic capsule filling
machine. The execution team comprises of:

DEPARTMENT DESIGNATION NAME SIGNATURE DATE

PRODUCTION

QUALITY CONTROL

QUALITY ASSURANCE

3.0 GENERAL CONSIDERATION/PREREQUISITE:

3.1 Approved SOP of the equipment shall be available.

3.2 The impact analysis of the equipment shall be recorded in the summary sheet.

The installation and operational qualification of the equipment shall be successfully completed before the execution
3.3
of the performance qualification.

All the deficiencies and discrepancies related to the equipment that affect the product quality and corrective action
3.4
taken shall be recorded in the appropriate section of the protocol.

The analytical test results and other reports related to the equipment shall be attached to the performance qualification
3.5
of the equipment and finally verified.
 After completion of PQ activities, equipment shall be cleaned as per respective cleaning SOPs and released for
3.6
manufacturing.

4.0 REVALIDATION CRITERIA:

The machine shall be revalidated if:

There are any major changes, which affect the performance of the equipment. After major changes in the
components of the equipment.

5.0 PERFORMANCE QUALIFICATION PROCEDURE:

5.1 METHODOLOGY:

The principle of the Automatic capsule-filling machine is to fill the capsule with a blend within the capsule
specification limit and at a specified speed.
This machine can be used for filling of capsules at the desired weight so as to achieve post-filled capsule tests such as
locking length, Appearance, and weight variation within permissible limits. Blend shall be charged to the hopper of
the Automatic capsule filling machine with the help of a lifting & posting device. Filled capsules are collected in the
SS IPC. The samples shall be collected at 60, 80, and 106 SPM.

6.0 ENVIRONMENTAL CONDITION:

Temperature(Limit: 25 ± 20 C) Humidity (RH) (Limit: NMT 50 ± 5%)

MAX MIN MAX MIN

INFERENCE:

————————————————————————————————————————————-

————————————————————————————————————————————-

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Checked by:

Date:

7.0 CAPSULE PARAMETERS:

 Sr. No. of Capsules
Parameters In-Process Specifications
No. Req.

Scarlet / Scarlet cap/body Empty hard gelatin capsules of

1 Appearance 100
size ‘2’

Weight of 20 filled
2 7.10 g ± 2 %(6.96 to 7.24 g) 20
Capsules

Weight of 20 Empty
3 1.20 g ± 2 %(1.18 to 1.22 g)
capsules

4 Uniformity of weight 355 mg + 5.0 % 30

5 Locking length (17.2 to 18.0 mm) 04

7.1 IN-PROCESS CHECKS:

At 60 SPM

Dat Time Appearance Locking length (17.2 to 18.0 Average [Link] filled 20 DoneB Ckd.
e
 mm) capsules y By

At 80 SPM

Dat Locking length (17.2 to 18.0 Average [Link] filled 20 DoneB Ckd.
Time Appearance
e mm) capsules y By
 At 106 SPM

Dat Locking length (17.2 to 18.0 Average [Link] filled 20 DoneB Ckd.
Time Appearance
e mm) capsules y By

7.2 UNIFORMITY OF WEIGHT:

Limit = none of the capsules should be deviated by ±7. 5 %

NMT 2 capsules should be deviated by ±10 %

60 SPM 80 SPM 106 SPM

[Link]. Wt of Wt of Fill wt Wt of Wt of Fill wt Wt of Wt of Fill wt

 Filled empty Filled empty Filled empty
of caps. of caps. of caps.
caps. in caps. in caps. in caps. in caps. in caps. in
In mg In mg In mg
mg mg mg mg mg mg

1.

2.

3.

4.

5.

6.

7.

8.
9.

10.

11.

12.

13.

14.

15.

16

17

18
19

20

21

22

23

24

25

26

27

28
29

30

Total
wt.

Min.

Max.

Limit: ± 7.5 %—————–mg to ——————————–mg

Limit: ± 10 %—————–mg to ——————————–mg

INFERENCE:

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————————————————————————————————————————–

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Checked by:

Date:

8.0 DEFICIENCY AND CORRECTIVE ACTION(S) REPORT(S):

The following deficiency was verified and corrective actions were taken in consultation with the validation team.

Description of deficiency:
Corrective action(s) taken:
Reviewed By:

Date:

9.0 Annexure (s):

[Link]. Annexure No. Title of Annexure

10.0 PERFORMANCE QUALIFICATION FINAL REPORT:

10.1 SUMMARY:

10.2 CONCLUSION:
10.3 FINAL REPORT APPROVAL:

Trial, It has been verified that all tests required by this report are completed, reconciled, and
attached to this protocol or included in the qualification summary report. Verified that all
amendments and discrepancies are documented, approved, and attached to this protocol.

The signature in the block below indicates that all items in this qualification report of the AF – 25
(Modal Name) Automatic Capsules filling machine have been reviewed and found to be acceptable
and We have satisfactorily resolved all variations or discrepancies. The equipment can be taken for
production (✅).

NAME DESIGNATION DEPARTMENT SIGNATURE DATE

PRODUCTION

QUALITY CONTROL

QUALITY ASSURANCE