Performance Verification of Tablet counting machine
This article contains about , Performance Verification report for Tablet counting machine which is used in bottle packing lines for tablet and capsule filling.
Performance Verification report for Tablet counting machine.
1) Objective:
- To ensure that the target number of tablet / capsule should be filled into container without any damage.
- To ensure that the 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.
2) Scope:
- Applicable for counting of tablet / capsule using tablet counting machine in container packing line.
3) Principle:
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 tablet / capsule guide. When the tablets / capsules drop through tablet / capsule guide, the optical system count the each individual tablet / capsule.
4) Site of the Study:
Packing Department
Location:- ______________
5) Responsibility:
Representatives from:
Packing : _____________________
Engineering : ______________________
Quality Assurance : _____________________
6) Description of the Equipment to be validated / used:
Tablet Counting Machine
Code No: ____________________
Make: _______________________
Tablet counting machine Qualification done on. __________________
7) SOPs to be followed:
SOP for operating tablet counting machine POP: _____________________
8) Controls:
- Functioning of optical count sensor.
- Functioning of no bottle sensor, bottle jamming sensor & hopper level sensor.
- Availability of compressed air supply.
- Functioning of rejection system.
- Correct entry of the length, width and diameter of tablet / capsule in product edit mode for accuracy.
- Proper adjustment of vibrator speed 1, 2, 3 and conveyor speed.
Training:
Training details of personnel involved in validation
| Name | Training Status | Training reports availability | Checked by |
Precautions:
Safety aspects while operation of equipment and process must be ensured.
9) Validation procedure:
Product : ________________ Batch No : _______________
Batch Size : ________________ Formulation Code : _______________
Pack size : ________________ Type of Pack : _______________
Date of study : ________________
10) Acceptance criteria:
- Tablets should be fed online from vibrator tray. The speed of other related trays and gate should be adjusted to meet constant on all three trays.
- Speed of counting should be met to required speed depend on number of target count.
- The free flow of bottle should be on conveyor.
- The counted tablets / capsule should fall into the bottle.
- The gate movement should be smooth to allow bottle positioning and discharging after filling.
11) Non compliance (Deviations):
Details of Deviation (if any):
| Deviation Report Number | Deviation Report Dated | Checked by |
|
|
Details of Out of Specification (if any):
OOS Report Number |
OOS Report Dated | Checked by |
|
|
12) Type of validation:
Concurrent validation
13) Frequency:
One validation exercise per year.
14) Results:
|
TABLET/CAPSULE COUNTING MACHINE CODE NO: |
|
| Product: | |
| Batch number: | |
| Bottle fill value: | |
| Time | Filled quantity |
| Initial | |
| Half an hour | |
| 1 hour | |
| 1 hour 30 minutes | |
| 2 hours | |
| 4 hours | |
| 6 hours | |
| 8 hours | |
| 10 hours | |
| 12 hours | |
| 14 hours | |
| 16 hours | |
| 18 hours | |
| 20 hours | |
15) Summary of findings of experiment (Inference):
16) Recommendations:
17) Team Approval:
___________ _____________ ________________
Packing Engineering Quality Assurance
Date: Date: Date:
18) Review (Inclusive of follow up action, if any):
19) Approved by:
___________________ __________
Plant Quality Assurance GM-Operation
Date: Date:
