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

PROTOCOL APPROVAL:

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

1. OBJECTIVE:
   1. To give the methodology and procedures for performing performance qualification of the newly procured Induction Cap Sealing Machine on the bottling packaging line having ID XYZ.

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 protocol 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:

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

• 5.1 Performance Verification of Equipment:
• 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 equipment’s 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 data generated during PQ study shall be recorded in the qualification report.

• 5.1.3 Sealing of 33 mm Caps with 40 cc HDPE Bottles at different speed
• 5.1.3.1 Before starting of equipment, set it as per 33 mm cap and 40 cc bottle.
• 5.1.3.2 The ‘gap between induction sealing head and bottle cap’ and ‘induction heating power in %’ shall be adjusted as per conveyer speed and cap/bottle size until the bottle is sealed properly. Same shall be recorded in the report.
• 5.1.3.3 Once the equipment set, start to supply HDPE bottles containing product on infeed conveyor with variable conveyor speed one by one.
• 5.1.3.4 Equipment shall be run at each speed.
• 5.1.3.5 Randomly collect the few sealed bottles from out feed conveyor and Check physically for improper sealing and burned sealing wad and inside surface of cap. Check for any leakage at sealed portion by Leak test as per SOP No.: XYZ.
• 5.1.3.6 While running the equipment at each speed, place foil (sealing wad) missing cap bottle on infeed conveyor as challenge to foil missing cap bottle detect sensor and at same time check whether that inferior bottle is rejected by reject cylinder automatically and alarm message is flashed on LCD screen.
• 5.1.4 Sealing of 53 mm Caps with 1300 cc HDPE Bottles at different speed
• 5.1.4.1 Steps 5.1.3.1 to 5.1.3.6 shall be followed for study with 53 mm Cap and 1300 cc HDPE Bottle.

5.1.5 Critical parameters and acceptance criteria:

Sr. No.	Critical parameter	Acceptance criteria
1.0	Check for improper sealing and burned sealing wad and inside surface of cap.	There shall be no single bottle found with improper sealing and burned sealing wad and inside surface of cap.
2.0	Leak test	Leak test shall be negative i.e. tablets, silica gel sachet and cotton shall not be moistened.
3.0	Foil (sealing wad) missing cap bottle detect sensor challenge test	Message ‘No Foil’ shall appear on LCD screen.Red colour lamp shall glow on.Buzzer shall off.Reject cylinder shall reject foil (sealing wad) missing cap bottle online.
4.0	Record the set gap between induction sealing head and bottle cap at each bottle size and speed study.	For data collection.
5.0	Record the actual heating power in % at each bottle size and speed study.	For data collection.

• 6.0 DEVIATION REPORT:
  • Any deviation occurred during the qualification study shall be documented. The impact on installation qualification of equipment by the deviation shall be evaluated and documented.
•  7.0 CHANGE CONTROL:
  • Any change occurred during the qualification study shall be documented. The impact on installation qualification of equipment by the change shall be evaluated and documented.

• 8.0 SUMMARY AND CONCLUSION OF PERFORMANCE QUALIFICATION:
  • Based on the data collected during qualification, appropriate summary and conclusion shall be made on the performance qualification.

• 9.0 REPORT APPROVAL:
  • All the data collected during qualification study shall be recorded in the qualification report along with adequate raw data. The report shall be finally approved by Head-QA.

10.0 REFERENCES:

Nil

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