Title: Operation and Cleaning of Tablet and Capsule Hand Counter
- Objective:
To define procedure for Operation and Cleaning of Tablet and Capsule Hand Counter.
- Scope:
This SOP is applicable to all Hand Counters used for counting of tablets/capsules during bulk packing in packing section.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedure for operation and cleaning of Tablet and Capsule Hand Counter.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/ rinse sample. To review and approve the SOP and Annexure.
- Quality Control Department: To analyse and report of the swab/rinse samples.
- Accountability:
Head, Production Department. Head, Q.A. Department.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
- Remove the previous batch residue.
- During end of the shift.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
- Type B Cleaning: Wet cleaning by using soap solution in the following cases.
- Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
- Change in product.
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product.
- After seven days of cleaning before use, if equipment is not in use.
- After replacement or repair of any product contact part.
- Monthly, if it is not in use after cleaning.
- Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
- Definition:
- Procedure
| Precautions: | ||
| 5.2.1 | Visually check and ensure that, the hand counter is clean. | |
| 5.2.2 | During filling of counted tablets in container, ensure that, the tablet should not miss in counter or should not drop outside the container. | |
| 5.2.3 | All the personnel involved in counting operation should wear the hand gloves and nose mask. | |
| 5.3 | Procedure | |
| 5.3.1 | Ensure that, the equipment is cleaned and line clearance is taken as per line clearance checklist on the BPR. | |
| 5.3.2 | Check that the temperature and relative humidity (25oC ± 2oC and 55% ± 5% RH) are within the limit at all stages of manufacturing and packing. | |
| 5.3.3 | Ensure that the Hand Counter is used as per product shape/ size by putting the tablets /capsules in the Hand Counter. | |
| 5.3.4 | Press the lever and ensure that the hand Counter flap is working properly. | |
| 5.3.5 | Fill the tablets /capsules in the individual cavity of the Hand Counter tray. | |
| 5.3.6 | Then shake the counter to drop the over-filled extra tablets from the Hand Counter to the tablet container. | |
| 5.3.7 | Open the flap of the Hand Counter and pour the Tablets / Capsules from the counter tray slowly to the packing container. | |
| 5.3.8 | Initially cross check the tablets/capsules manually, counted by Hand Counter to assure correctness as per number of cavities. | |
| 5.3.9 | After completion of counting activity label the Hand Counter as “To be type A cleaned” or To Be Type B cleaned” as applicable. | |
| 5.3.10 | Record the usage activity in “Equipment log book. | |
| 5.4 | Cleaning | |
| 5.4.1 | For Type A (Batch to Batch ) Cleaning: | |
| 5.4.1.1 | Remove all tablets/ documents of previous batch from the area. | |
| 5.4.1.2 | Initially, remove the dust accumulated on Hand Counter by using dry duster. | |
| 5.4.1.3 | Clean the outer, inner surface and cavity of Hand Counter by wiping with clean dry duster. | |
| 5.4.1.4 | After ensuring cleanliness, affix “Type A Cleaned” label to the Hand Counter. | |
| 5.4.2 | For Type B (Product to Product) Cleaning: | |
| 5.4.2.1 | Remove all tablets/ documents of previous batch from the area. | |
| 5.4.2.2 | Initially, remove the dust accumulated on Hand Counter by wiping with dry duster. | |
| 5.4.2.3 | Cover the Hand Counter with poly bag and transfer to wash area on trolley for cleaning. | |
| 5.4.2.4 | Wash the Hand Counter with 10-15 litres of potable water to remove the powder. | |
| 5.4.2.5 | Apply 0.1% soap (teepol) solution to the Hand Counter, and then wash with 10-15 litres of potable water to remove the traces of soap solution. Finally rinse with 10-15 litres of purified water. | |
| 5.4.2.6 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the samples. | |
| 5.4.2.7 | Record the activity in equipment log book. | |
| 5.4.2.8 | Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.4.2.4 to 5.4.2.6 | |
| 5.4.2.9 | Dry the Hand Counter with the help of clean dry duster/in tray dryer. | |
| 5.4.2.10 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.4.2.11 | Cover the Hand Counter with fresh poly bag and keep in to the spare parts room. | |
- Abbreviation:
| Abbreviation | Expansion |
| ml | Milliliter |
| BPR | Batch Packing Record |
| ± | Plus or Minus |
| oC | Degree Centigrade |
| % | Percent |
*Note – Ready to use SOP available in “DOWNLOAD” Section.