In this post Standard Operating Procedure of Operation of Strip Pack machine in Pharmaceuticals is describe.
Purpose: To lay down operating procedure for the Operation of Strip pack machine.
Scope: This procedure is applicable for ...........
Responsibility: Production Chemist
To supervise the activity
Pre-operating Check: Check no material or residue should be there.
Equipment used: Gension strip pack machine
Operating procedure:
1. Check the cleaning of strip pack machine and their surrounding area.
2. Start on the main switch.
3. Adjust the hopper with respect to Bowl Dish.
4. Set main gear and cutting gear.
5. Fit the fiddling channel and adjust in such way that the tablets comes in center of sealing roller pockets
6. Remove the Printing Drum from the Batch Code Printing unit & fix
The stereos on the drums as per the pitch marks on the drum
7. Remount the drum on to the Batch Code Printing unit.
8. The heater should be switched on and thermostat setting adjusted to provide heating condition predetermine for particular strip packing product.
9. Wait for10 to 15 minutes for heaters to attain the temperature
10. Placed printed aluminum foil and plain aluminum foil on to the strip machine.
11. Set the speed of the machine to the minimum.
12. Pass the printed and plain aluminum foil over the rollers and check the cutting and sealing of strips.
13. Take out one sample of over printed foil for the approval of the over printed matter, which must cover the impression of all stereo on the over-printing drum.
14. Check the following details
Batch number
Manufacturing date
Expiry date
Retail price
It thoroughly against the BMR
15. If all the details meet the Quality standards then only send the overprinted foil to the QA department for their approval
16. Mean while bring the bulk for packing from the inspection area bring the bulk to be packed.
17. While brining the bulk check the following details from the label
A Product
B Batch number
C manufacturing date
D Expiry date
18. Check the empty strips for the setting parameters like sealing, pocket centering, cutting etc.
19. Wear gloves and pour the tablets in to the hopper and ensure that the tablet are coming through channel with ease; if not set the vibrator and channel.
20. Then check the sealing roller and forming roller temperature should lie within the normal limit.
21. Check the quality of the printing and add if necessary ink and thinner and adjust the printing as in the overprinted approved foil or better than that.
22. Start the machine record the start time in BMR and collect strips as per BMR and keep those for the leak-seal test.
23. If the Leak seal test passes then start the striping.
24. Monitor the over all quality of the final strips/blister through out the stripping operation.