Capping machine-Performance Verification protocol

This article contains about Performance Verification protocol for capping machine

Performance Verification protocol for capping machine

Objective:

To ensure that the Container Capping machine is functioning as it is supposed to pass the capped containers to Induction sealing machine.

 Scope:

Applicable to Container Capping by using container capping machine.

Principle:

Capping of Containers by container capping machine by means of pressure spindles.

Site of study:

Packing Department

Location:

To be recorded in Report.

Validation Team:

Representatives from:

Production              :

Quality Assurance  :

Engineering             :

Description of the machine to be Validated / used:

Machine                        : To be recorded in Report.

Make                             : To be recorded in Report.

Code No.                       : To be recorded in Report.

Qualification Date          : To be recorded in Report.

Standard Operating Procedure (SOP) to be followed:

SOP for Operating Capping Machine: Details to be recorded in Report.

 Controls:

Requirements:

1. Container Capped by rotating pressure spindles.
2. Container without cap should be rejected by rejection system of capping machine.
3. Container with tilted cap should be rejected by rejection system of capping machine.

Training :

Trained personnel (details to be recorded in the Report).

 Validation Procedure:

1. Ensure that the machine is cleaned as per reference SOP.
2. Adjust the capping machine conveyor so that the filled containers should flow freely.
3. The caps from cap hopper pass from the chute channel onto container.
4. The spindle should apply sufficient pressure on the cap over the container so as to have efficient torque.
5. Check five capped containers for capping quality at initial, middle and end of the batch.
6. Challenge the sensors for No cap and titled cap at initial, middle and end of the batch.
7. Record type of Cap in validation Report. (e.g. One touch Cap, Screw Cap, CRC Cap)

 Acceptance criteria:

1. 1. The Capping should be effective and uniform throughout the batch run.
   2. Machine should reject the container with No cap and Titled cap.

Non Compliance:

Details of deviations (including justification of acceptance) done to successfully carried out the validation exercise and any OOS results obtained should be checked and recorded in the Report.

 Type of Validation:

Concurrent Validation.

 Frequency

One Validation exercise per equipment every two years.

Results:

Record the observations during the study.

 Summary of finding of experiments (inference):

To be recorded in the Report.

Recommendation:

To be recorded in the Report.

 Team Approval:

The individuals who have performed the Validation study, Supervised the Validation, completed the records, performed the testing of the product should approve the validation report.

 Review:

(Inclusive of follow up action, if any). To be recorded in the Report.

 Approved by:

Validation Report should be finally approved by plant Quality Assurance and plant Head.

 Annexures:

Annexures (if any) attached to the validation report should be recorded.

 Abbreviations:

SOP         : Standard Operating Procedure

OOS        : Out Of Specification

No.           : Number