SOP Title: Operation and Cleaning of Multimill
- Objective:
To define the procedure for Operation, Cleaning and Preventive Maintenance of Multimill.
- Scope:
This SOP is applicable to Multimill, used for milling of granules installed at the granulation section.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation, cleaning and preventive maintenance of Multimill.
- Quality Assurance Department: To review and approve the SOP and Annexure
- Engineering Department: To follow the procedures laid down for the operation and cleaning of Multimill wherever applicable.
- Accountability:
Head, Production.
Head, Engineering.
Head, QA.
- Procedure:
- Definition:
- Production Associate: Executive or operator of Production Department trained to perform duties as per this SOP.
- QA Associate: Personnel of QA Department trained to perform duties as per this SOP.
- QC Associate: Personnel of QC Department trained to perform duties as per this SOP.
- Engineering Associate: Personnel or operator of Engineering Department 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.
- Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
- Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
- Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Switch “OFF” the electrical mains during cleaning / setting of the Multimill. | |
| 5.2.2 | Inch the Multimill and ensure that, the screen is properly fitted and it is not touching the blade. | |
| 5.2.3 | Do not touch any moving parts during operation. | |
| 5.3 Operation of Multimill | ||
| 5.3.1 | Check the cleanliness of the Multimill, Screen, Hopper and blades before fixing the parts. | |
| 5.3.2 | Insert the blades in grooves provided on the rotor. Then insert SS rod into the slot to hold the blades. | |
| 5.3.3 | Insert the rotor assembly into the shaft of the Multimill. | |
| 5.3.4 | Then tighten the Allen key bolt from bottom. | |
| 5.3.5 | Then fix the required size of screen as per the BMR by holding plate and tight the screw provided. | |
| 5.3.6 | Rotate the shaft by inching to make sure that the blade is not touching the screen. | |
| 5.3.7 | Fix the hopper with gasket by tightening the wing nuts provided on both the sides of the plate. | |
| 5.3.8 | Fix the outlet hopper to Multimill, by inserting the holding nuts into the slots provided in the milling chamber. | |
| 5.3.9 | Check the fitting of all parts physically before switch ‘ON’ | |
| 5.3.10 | Check the proper fitting of parts, then switch ‘ON’ the main power supply. | |
| 5.3.11 | Keep the cleaned container lined with poly bag (if required tie the poly bag to the hopper) below the outlet of the hopper to collect the milled or sized granules. | |
| 5.3.12 | Now switch ‘ON’ the starter of the Multimill and put the material to be milled slowly in to the hopper. | |
| 5.3.13 | Flow of material should be controlled by plate to avoid clogging. | |
| 5.3.14 | Collect the Milled granules through the outlet hopper into the clean container. | |
| 5.3.15 | Record the usage activity of Multimill in the “Equipment Log book’ as per attached Annexure. | |
| 5.3.16 | Record usage and cleaning activity of screens in “Usage and Cleaning log for screens” as per Annexure. | |
| 5.3.17 | After completion of milling label the Multimill as “Type A or Type B cleaning” as per the requirement. | |
| 5.4 TYPE A Cleaning of Multimill (at the end of shift or During Batch Change Over ) | ||
| 5.4.1 | Affix “To Be Cleaned” label to the Multimill. | |
| 5.4.2 | Remove, if any previous batch granules present inside the Multimill. | |
| 5.4.3 | Dismantle and dry clean the screen, screen holding plate and hopper. | |
| 5.4.4 | Dry clean the outer surface, lid of the Multimill with clean duster. | |
| 5.5 TYPE B Cleaning of Multimill (During Product Change Over) | ||
| 5.5.1 | Remove the status label. Affix “To Be Cleaned” label. | |
| 5.5.2 | Dismantle the feed hopper, outlet hopper, Screen along with the screen holder plate by losing the wing nuts. | |
| 5.5.3 | Blades and scraper should be disassembled from beater by pulling out the retaining pins and pulling down the blades and scraper from the gaps provided in beaters. | |
| 5.5.4 | Transfer all parts to the wash area with “To Be Cleaned “label and wash these parts with 20 litres of potable to remove the powder. | |
| 5.5.5 | Then scrub all the parts with nylon scrubber using 0.1% soap (teepol) solution. Then clean all the dismantled parts with 25-30 litres of potable water to remove the traces of soap solution. Finally rinse with 15-20 litres of purified water. | |
| 5.5.6 | Roof of milling chamber to be wiped with clean moist duster then dry with dry clean duster. Care should be taken to avoid water entering in the electric motor. | |
| 5.5.7 | All the loose gaskets are cleaned and examined to confirm that these are not cracked or likely to shred any particles. | |
| 5.5.8 | The exterior parts of the machine such as the base, the motor and the pulley drive chamber covers are wiped with dry clean duster. | |
| 5.5.9 | Intimate to QA department to collect the rinse sample of the cleaned parts and equipment as per SOP “Procedure for residual sample collection and analysis of equipment or machine” to confirm the absence of previous product. | |
| 5.5.10 | Ensure the cleanliness and dry the parts with dry clean cloth / tray dryer. | |
| 5.5.11 | Cover the cleaned equipments with a Poly bag affix “Cleaned” status label. | |
| 5.5.12 | Record the cleaning activity in the equipment log. | |
| 5.6 | Action plan in-case of Breakdown | |
| 5.6.1 | Inform to the Head Production, Head QA, and Head Engineering regarding breakdown. | |
| 5.6.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.6.3 | Fill the “Incident Report “and submit to Quality Assurance Department. | |
| 5.6.4 | Collect the Milled granules from the outlet hopper, label and keep it separately. | |
| 5.6.5 | Collect the un-milled granules from the hopper, inside the sieves if any, label and keep it separately. | |
| 5.6.6 | After rectification, clean the mill and check the working condition before proceeding for milling operation. | |
| 5.6.7 | Record breakdown activity in Equipment log book . | |
| 5.6.8 | After completion of repairs, the operations can be resumed. If break down is major perform Type A or Type B cleaning as per the requirement. | |
| 5.7 | Maintain the “Inventory Record for Screens” as per Annexure. | |
- Abbreviation:
| Abbreviation | Expansion |
| TAB | Tablet |
| SS | Stainless Steel |
| BMR | Batch Manufacturing Record |
| IPA | Iso Propyl Alcohol |
| ml | Milliliter |
| % | Percent |
| v/v | Volume by Volume |
*Note – Ready to use SOP available in “DOWNLOAD” Section.