Verification Protocol for Tablet counting machine

This article contains information about, Performance Verification protocol for Tablet counting machine

Performance Verification Protocol for Tablet counting machine

Objective :

• To ensure that the target number of tablet / capsule should be filled into the container without any damage.
• To ensure that sensor should count each individual tablet / capsule falling into the container.
• To ensure that gate movement shall be smooth to allow bottle positioning and discharging after dosing.

Scope:

 Applicable for counting of tablet / capsule by using counting machine in container packing line.

Principle of Tablet counting Machine :

 12 lane of feeding tray feed the tablet and capsule by means of vibrators. Vibrator feed tablets / capsules continuously without stopping the tablets / capsules drop from each channel to tablets / capsules guide. When the tablet / capsule drop through guide, the optical system count each individual tablet and capsule.

Site of the Study 

Packing Department

Location : To be Recorded in the Report

Responsibility while 

 Representatives from:

Packing:

Engineering:

Quality Assurance:

Description of the Equipment to be used:

 Tablet / Capsule Counting Machine

Code No. : Details to be recorded in the report

Date of tablet / capsule counting machine qualification done on to be recorded in Report.

SOPs to be followed:

 SOP for operating tablet / capsule counting machine: (SOP No. to be recorded in the report.)

 Controls:

1. Functioning of optical count sensor.
2. Functioning of no bottle sensor, bottle jamming sensor & hopper level sensor.
3. Availability of compressed air supply.
4. Functioning of rejection system.
5. Correct entry of the length, width and diameter of tablet / capsule in product edit mode for accuracy.
6. Proper adjustment of vibrator speed 1, 2, 3 and conveyor speed.

Training:–

Trained personnel details to be recorded in the report

Precautions to be taken during Performance Verification of Tablet counting Machine :

Safety aspects while operation of equipment must be ensured.

Validation Procedure for Performance Verification of Tablet counting Machine :

Enter the product details such as product name, batch number, batch size and formulation code in validation report.

Carry out the experiment and record it in validation report.

1. Clean the machine as per SOP.
2. Load the product into the hopper.
3. Operate the machine as per SOP.
4. Check the filled bottles for correct fill value at initial, after 30 minutes, 60 minutes, 90 minutes & 120 minutes and record it.
5. Continue for every 2 hours if batch exceeds more than 2 hours.

Acceptance criteria for Performance Verification of Tablet counting Machine

1.  Tablet / capsule should be fed online from vibrator tray. The speed of other related trays and gate should get adjusted to meet constant on all three trays.
2. Speed of counting should be met to required speed depend on number of target count.
3. The free flow of bottle should be on conveyor.
4. The counted tablet / capsule should fall into the bottle.
5. The gate movement should be smooth to allow bottle positioning and discharging after filling.

The following time value should entered on product specification.

1. Count sensor delay time.
2. Gate closing time.
3. Shutter closing time.
4. Correct set fill value.

Non Compliance:

 Details of Deviations (including justification of acceptance) done to successfully carry out the exercise and any OOS results obtained should be checked. (Attach the details in the validation report)

Type of validation:

Concurrent validation

 Frequency for performance Verification of Tablet counting Machine :

 One validation exercise per year.

 Results for :

 Record the observations in the validation report during the study.

Summary of Findings of experiment (Inference):

 Summary after validation to be recorded in the report.

 Recommendations (Including requirement of any additional documentation):

Any recommendations after validation to be recorded in validation report.

Team Approval for Protocol for Tablet/Capsule counting machine

 The individuals who have performed the validation study, supervised the validation, completed the records should approve the validation report.

 Review (Inclusive of follow up action, if any):

 Plant Quality Assurance and Plant Head should review the validation report. The report should include any follow up action if required.

 Approved by:

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

 Annexures:

 If any, to be attached to the Validation report.

Abbreviations:

 SOP        :         Standard operating procedure.

No.           :          Number

OOS        :         Out of specification.