Process flow of granulation process

First, the total process flow : picking → material removal → processing → feeding → soft materials (called adhesive) → wet particles → drying → whole grain → weighing mixed (plus strawberry powder flavor) → store a raw material Smash and sieve.

1. Related process: budget receiving materials> report to the statistician to take the picking list> warehouse picking to the net point (check whether the outer bag is damaged, if there is damage should promptly explain with the warehouse staff) > unpacking Disinfect the original auxiliary material storage room> sifting the preparation material room. (Do a good job and fill in the production record and management record)

2. The cefixime granules are sieved with raw materials: cefixime is over 100 mesh, mannitol is over 60 mesh, and crospovidone is over 60 mesh.

3. How to get the amount of material received in advance.

To ensure sufficient stock preparation, it is necessary to determine the quantity of materials received in advance based on the weekly production plan and the record of the original raw materials used in the post.

4. What do you need to do in the warehouse?

Check the lot number, product name, quantity, and bank lot number of the material, and take the corresponding material inspection report.

5. When dismantling the packaging, check whether the packaging at the material is damaged, whether the color of the material is abnormal or not, and promptly feedback to the quality inspector or technician. 6. Remove the outer packaging material with 3% hydrogen peroxide to sterilize the outer surface of the material, and affix the material card to the original auxiliary material storage room.

7. If the raw and auxiliary materials are crushed and sieved, the screen mesh number, material name, batch number and quantity of the required materials must be checked.

8. The yield of the material after sieving should not be lower than 99.5%.

9. The processed material should be reported to the craftsman with the original batch number, the batch number and the total weight of the material.

10. For unqualified materials, return them to the original packaging or raw material barrels and seal and mark them.

two. Feed weighing

11. (1) Preparation before production.

12. 1. Check that there are no residues or production records in the work area that are not related to this production, and have been cleaned and disinfected.

Within the validity period.

13. 2. Check the pressure difference, temperature and temperature in the production area within the specified range.

14. 3. At the craftsman, pick up the order and the required records for this production. (remember to review the order)

15. 4. According to the instruction sheet, hang the production status card at the production door and fill in the corresponding product name, batch number, specification, and production date.

16. 5. Before the production, calibrate the required weighing instrument with the standard weight.

17. 6. In the production equipment, the scale is replaced with the production status card (running)

18. 7. Receive the required production equipment, tools, containers, etc., and confirm that the cleaning and disinfection is within the validity period.

19. 8. According to the instruction sheet, collect the processed raw materials and check the product name and batch number. 20. (2) Operation

21. 1. Start the weighing cover for 5 minutes, open the scale, and when it is displayed as 0.00, push the 600L IBC onto the scale and remove the skin (ie, display 0.00), turn up the bridge and fix it.

22. 2. According to the instruction sheet, check the item name, batch number, and then use the hoist to feed the 600L IBC. According to the net weight of the order, accurately weigh it, that is, 100% of the material, and all the materials are put in the peeling manner.

23. 3. All weighing operations must be double-checked (such as checking the item name, batch number, checking the value displayed on each scale of the material on the scale or electronic scale, must be consistent with the value on the order)

24. 4. The container used in the weighing process shall be one for each material and shall not be mixed to avoid cross-contamination.

25. 5. Batch records and management records must be filled in time (no memo or memoirs must be written)

26. 6. After each pot is weighed, mark the 600L IBC status card with the clear information, product name, specification, lot number (time) and quantity, and finally move to the next step.

27. After the weighing is completed, the remaining materials should be inspected in time, and the material card information should be updated to fill in the actual material information. 28. 8. Place the sunset yellow aluminum lake, aspartame and other 40 mesh sieves into the 600L hopper for use.

29. 9. Electronic use.

30. (3) Preparation of adhesives

31. 1. Calculate the number of binders required. (25% povidone solution), povidone number = 25% povidone solution * 25% (0.25)

32. 2. Weigh the calculated number of povidone, and mark the foam with the material card and move it to the pulping room to calculate the amount of purified water required. Purified water weight = 25% povidone solution weight - povidone weight

33. 3. Weigh the amount of purified water required, then place the povidone in it and stir it to a uniform state with a stirrer.

34. 4. Mark the information of the adhesive to clean the outer surface of the container.

three. Wet granulation drying

35. 1. Process parameters of wet granulator (premixing > shotcreting > soft material)

36. 2. The boiling temperature of the boiling dryer is controlled at 60 to 80 degrees during the preheating process, and the inlet air temperature should be controlled at 80 degrees. When the material temperature reaches (50 degrees) after the suction is completed, the inlet air temperature is set. For (55 degrees), after the material temperature reaches (50 degrees), it needs to be dried (25 to 30 minutes), and the material is dried and dried.

37. 3. Wet granulation After the addition of the binder, the process of making the soft material is required, sampling observation (viscosity of the soft material), judging whether it is necessary to add (adhesive), the time for making the soft material is controlled at 8 10 minutes, if you find that the humidity of the soft material is too large, you should try to (short) the time of the material.

38. 4. Check the screen (integrity) after the swing machine is finished.

39. 5. When the material is dried and shaken to sift the whole grain, it is necessary to control (the material is even) into the vibrating screen. After the material in each pot is vibrated, it is necessary to check (whether or not the wire is attached to the magnet) to judge whether there is a bad screen. Observe whether the pure particles are uniform and the particles are too fine. It should be communicated with the soft material personnel in time. After the last pot of the batch is shaken, all the materials (fine powder, head, pure particles) of the batch should be cleaned up.

Fourth, the total mix

40. 1. Transfer the sieved pure granules and residual material (fine powder), transfer them to the weighing room and weigh them. The remaining material is 200L IBC device and the intermediate product card is attached. The remaining material information (product name, batch number) , quantity), pure particles on the 600L IBC status card to indicate product information.

41. 2. Calculate the amount of fragrance based on the net weight of the pure particles and the net weight of the remaining material, and the theoretical number of flavors. (Flavour amount = theoretical flavor amount * pure particle weight / (pure particle number + residual material amount)

42. 3. Weigh the calculated essence and add it to the pure granules after passing through a 60 mesh screen. Move all the pure granules (+ flavor) of this batch to the 2500 mixing room.

43. 4. Install the vacuum feeding device, then put all the pure particles into the 2500 mixing hopper, mix for 5 minutes (10 rpm), and then weigh and weigh the intermediate weight. (calculate material balance, and sampling).

OEM SERVICE: Tablet/Capsule/Micro/Premix

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