Induction Cap Sealing Machine Performance Qualification 

Report

  Equipment Name : Induction Cap Sealing Machine

Equipment Model
Sigma – II
No.:
Equipment Sr. No.: 213/11/-12
Equipment ID No.: XYZ
Equipment Area : XYZ
Equipment
Manufacturer Electronic Devices, Mumbai
Name :
To seal aluminium foil (sealing wad) retained in head space
Equipment
of cap with lip of HDPE bottles (containing product) online
Application :
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.
 o Quality Assurance Officer/Executive: To witness the qualification
study and ascertain that the study is conducted as per the protocol.
o Production Officer/Executive: To execute qualification study in co-
ordination with other departments.
o Head Maintenance: To review the qualification documents.
o Head Quality Assurance: To review and approve the qualification
protocol and report.

 4.0 EQUIPMENT DESCRIPTION:

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

Qualification of the equipment should meet the acceptance criteria outlined in the
following steps.

 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  
Sr. Speed of Set Actual Observations Observations Observations Checked
No Conveyor Power Power of Sealing of Burned of Leak test by
 Level
Level
Range Quality Wad sign/date
in %
in %
92-
1.0 20 Hertz          
98%
Set
Actual
Power Observations Observations Checked
Sr. Speed of Power Observations
Level of Sealing of Burned by
No Conveyor Level of Leak test
Range Quality Wad sign/date
in %
in %
92-
2.0 30 Hertz          
98%
Set
Actual
Power Observations Checked
Sr. Speed of Power Observations Observations
Level Sealing by
No Conveyor Level Burned Wad of Leak test
Range Quality sign/date
in %
in %
92-
3.0 40 Hertz          
98%

5.1.2 Challenge test report

Sr. Simulation Checked by

Acceptance Criteria Observations
No. Operation Sign/Date
Message ‘No Foil’ shall appear
Foil (sealing wad) on LCD screen.Red colour lamp
missing cap bottle shall glow on.Buzzer shall
1.0    
detect sensor off.Reject cylinder shall reject
challenge test foil (sealing wad) missing cap
bottle 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 of Leak test
Range Quality Wad sign/date
in %
in %
60-
1.0 20 Hertz          
70%
Set
Actual
Power Observations Observations Checked
Sr. Speed of Power Observations
Level of Sealing of Burned by
No Conveyor Level of Leak test
Range Quality Wad sign/date
in %
in %
70-
2.0 30 Hertz          
80%
Set
Actual
Power Observations Observations Checked
Sr. Speed of Power Observations
Level of Sealing of Burned by
No Conveyor Level of Leak test
Range Quality Wad sign/date
in %
in %
92-
3.0 40 Hertz          
98%

5.1.4 Challenge test report

Sr. Simulation Checked by

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

Remarks / Comments:

5.0 DEVIATION REPORT:

Sr. Deviation Justification for Impact on installation, operation

No. (s) acceptance criteria and 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.