Induction Cap Sealing Machine Performance Qualification Report - Pharmaceutical Updates

This document provides a performance qualification report for an induction cap sealing machine. The objective is to verify the performance of the machine under normal operating conditions. Tests were conducted using different bottle and cap sizes at various conveyor speeds. All tests showed proper sealing quality with no defects, and leak tests were negative. A challenge test was also performed and the machine correctly detected and rejected a bottle missing a sealing foil. The report concludes the machine performance meets all acceptance criteria.

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Induction Cap Sealing Machine Performance Qualification Report - Pharmaceutical Updates

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Chetan Ganesh Raut

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Pharmaceutical Updates was started to share knowledge among the pharma professionals & it will

become helpful to the pharma Professionals. The author of pharmaceutical updates is Chandrasekhar
panda who is having more than 13 years of Experience in Pharmaceutical Quality Assurance
department and he has worked in Pharma Companies like Cipla, USV & Aurobindo Pharma Limited.

Pharmaceutical Updates

Induction Cap Sealing Machine Performance

Qualification Report

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Equipment
Induction Cap Sealing Machine
Name :
Equipment
Sigma – II
Model No.:



Equipment Sr.
213/11/-12
No.:
Equipment ID
XYZ
No.:
Equipment Area
XYZ
:
Equipment
Manufacturer Electronic Devices, Mumbai
Name :
Equipment To seal aluminium foil (sealing wad) retained in head space of cap with lip of
Application : HDPE bottles (containing product) online by induction sealing method.
Report Date :

REPORT APPROVAL:

Prepared
Checked by Checked by Checked by Approved by
by
Signature
Date
Name
Head- Quality Head - Head – Quality
Department Production
Production Assurance Engineering Assurance

1. OBJECTIVE:
1. Objective is to record the findings of performance qualification (PQ) of Induction Cap Sealing
Machine.

2.0 SCOPE:

The scope of this exercise is limited to Induction Cap Sealing Machine having ID No. XYZ.

3.0 RESPONSIBILITIES:

Quality Assurance Officer/Executive: To prepare qualification report and co-ordinate the entire
qualification activity.
Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the
study is conducted as per the protocol.
Production Officer/Executive: To execute qualification study in co-ordination with other
departments.
Head Maintenance: To review the qualification documents.
Head Quality Assurance: To review and approve the qualification protocol and report.

4.0 EQUIPMENT DESCRIPTION:

Refer installation qualification protocol No.: XYZ.
5.0 PROCEDURE:

5.1 Performance Verification Report:

5.1.1 Performance of the equipment shall be verified by simulating the normal operation i.e.
sealing of aluminium foil (sealing wad) retained in head space of cap with lip of HDPE bottles
(containing product) online. While doing this exercise consideration shall give to the operating
range of the equipments i.e. size of bottle (40 cc and 1300 cc bottles), size of cap (33 mm and 53
mm caps) and speed of conveyor.
5.1.2 The generated data during performance of equipment are recorded in a following table.
5.1.3 Acceptance Criteria:
5.1.3.1 There shall be no single bottle found with improper sealing and burned sealing wad and
inside surface of cap.
5.1.3.2 Leak test shall be negative i.e. tablets, silica gel canister and cotton shall not be moistened.

5.1.1 Observations of sealing of 33mm Caps on 40cc HDPE bottles at different speed

Product Name
Bottle Size
Cap type
Cap size
Distance between coil and Cap surface

Set
Actual
Power Observations Observations Checked
Sr. Speed of Power Observations
Level of Sealing of Burned by
No Conveyor Level in of Leak test
Range Quality Wad sign/date
%
in %
1.0 20 Hertz 92-98%

Set
Actual
Power Observations Checked
Sr. Speed of Power Observations Observations
Level Sealing by
No Conveyor Level in Burned Wad of Leak test
Range in Quality sign/date
%
%
3.0 40 Hertz 92-98%

5.1.2 Challenge test report

Checked
Sr. Simulation
Acceptance Criteria Observations by
No. Operation
Sign/Date
Message ‘No Foil’ shall appear on LCD
Foil (sealing wad)
screen.Red colour lamp shall glow
missing cap bottle
1.0 on.Buzzer shall off.Reject cylinder shall
detect sensor
reject foil (sealing wad) missing cap bottle
challenge test
online.

Remarks / Comments:

5.1.3 Observations of sealing of 53mm Caps on 1300cc HDPE bottles at different speed

Product Name
Bottle Size
Cap type
Cap size
Distance between coil and Cap surface
Set
Actual
Power Observations Observations Checked
Sr. Speed of Power Observations
Level of Sealing of Burned by
No Conveyor Level in of Leak test
Range Quality Wad sign/date
%
in %
1.0 20 Hertz 60-70%

5.1.4 Challenge test report

Remarks / Comments:

5.0 DEVIATION REPORT:

Sr. Deviation Justification for acceptance Impact on installation, operation and

No. (s) criteria performance

6.0 CHANGE CONTROL:

7.0 LIST OF ANNEXURE:

8.0 SUMMARY AND CONCLUSION OF PERFORMANCE QUALIFICATION:

9.0 CERTIFICATION OF PERFORMANCE QUALIFICATION:

Performance Qualification is satisfactory. Yes/No

Hence equipment can be used for routine use. Yes/No

Head- Q.A.

For PQ Protocol can Refer https://pharmaceuticalupdates.com/2021/07/07/induction-cap-sealing-

machine-performance-qualification-protocol/
(https://pharmaceuticalupdates.com/2021/07/07/induction-cap-sealing-machine-performance-
qualification-protocol/)