1.0 Purpose:To lay down the cleaning and operation procedure of Comminuting mill.
2.0 Scope:This procedure is applicable to
3.1. References:3.1.1. Equipment manual
3.2.1. Attachment- 1 Status label
3.2.2. Attachment -2 Sequential Logsheet
4.1. Production4.1.1. Cleaning of equipment
4.1.2. Operation of equipment
4.1.3. Maintenance of equipment sequential log.
4.2. Quality Assurance:4.2.1. To ensure cleaning of equipment as per defined procedure
4.2.2. To provide equipment clearance in case of product change-over
4.2.3. To ensure maintenance of records
4.2.4. To ensure preventive maintenance schedule is followed.
5.0 Distribution:5.1. Manager Quality (Master Copy)
5.2. Manager Production
5.3. Production Shop Floor (Display Copy)
6.0 Definitions of terms:6.1. BMR: Batch Manufacturing Record
7.1 Cleaning procedure:
7.1.1. Batch to batch cleaning procedure:Following procedure is applicable for the same product between the two batches
22.214.171.124. Switch ‘OFF’ the mains of the Comminuting mill and remove the plug.
126.96.36.199. Remove all the adhering material from the body of the Comminuting mill using lint free dry cloth.
188.8.131.52. Wipe the Comminuting mill body with a clean moist lint free cloth followed by dry lint free cloth.
184.108.40.206. Label the status of equipment (Attachment-1).
Note: The cleaning of the clean equipment remains valid for 48 hours, if the equipment is not used within 48 hours, then it should be cleaned once again as per procedure 220.127.116.11.
7.1.2. Product change over cleaning procedureFollow the cleaning procedure given below for change over to another product or for the same product after every fifth batch.
18.104.22.168. Switch ‘OFF’ the mains of the Comminuting mill.
22.214.171.124. Remove ‘In process’ label and affix ‘To be cleaned’ label.
126.96.36.199. Remove dust from the body using lint free dry cloth.
188.8.131.52. Loosen lock screw and rotate electrical control panel by 90° and cover it with polybag.
184.108.40.206. Loosen the wing nuts at the four corners of the feed chamber and remove.
220.127.116.11. Loosen locking knob and rotate flat for locking by 90° to remove front wall for chamber.
18.104.22.168. Remove screen and side plate of comminuting chamber.
22.214.171.124. Wash all above parts with running potable water till free from the adhered material followed by scrubbing with 1 liter of 2% non-ionic detergent solution using nylon scrubber.
126.96.36.199. Rinse it with 40 liters potable water to remove the detergent.
188.8.131.52. Finally rinse all above parts with 60 liters of purified water.
184.108.40.206. Wipe external parts using dry lint free cloth.
220.127.116.11. Ensure that the equipment is visually clean.
18.104.22.168. Ensure that the area surrounding the machine is properly cleaned.
22.214.171.124. Remove ‘To be cleaned’ label and affix duly signed ‘Cleaned’ label on the equipment.
126.96.36.199. Intimate QA department to collect the wash water sample and wait for the approval.
188.8.131.52. On receipt of wash water approval, dry all parts using filtered compressed air.
184.108.40.206. Assemble the equipment.
Note: The cleaning of the cleaned equipment remains valid for 48 hours if the equipment is not used within 48 hours, then it should be cleaned once again as per procedure ‘220.127.116.11’
7.2. Operating procedure
7.2.1. Checks and precautions.18.104.22.168. During the milling operation, operator must wear gloves and nose mask.
22.214.171.124. During setting of the machine power supply to the mill must be disconnected.
126.96.36.199. Check the integrity of the sieve before fixing and also after completion of milling.
188.8.131.52. Ensure that the edges of the blades are not touching the screen by inching the blades.
184.108.40.206. Maintain the equipment sequential log.
7.2.2. Procedure:220.127.116.11. Remove ‘Cleaned’ label and affix it in the BMR.
18.104.22.168. Affix ‘Under Process’ label on the equipment.
22.214.171.124. Put the blade assembly either in knives forward or impact forward position depending on the product requirement as mentioned in the BMR.
126.96.36.199. Assemble all dismantled parts of comminuting chamber and screw feeder.
188.8.131.52. Put the required screen in the comminuting chamber as per BMR, ensure that the screen lie back onto the chamber end spacers.
184.108.40.206. Place a duly labeled container lined with polybag at the discharge outlet of the mill.
220.127.116.11. If specified in the BMR, connect all inlet and outlet water points. Turn ‘ON’ water, if required; ensure there are no leaks in the hose connections.
18.104.22.168. Switch ‘ON’ the mains.
22.214.171.124. Check free movement of the beater blade in inching mode.
126.96.36.199. Set the speed of the beater blade as required wit the help of regulator.
188.8.131.52. Load the material into the screw feeder and control the feed rate by adjusting the speed of feed screw with the help of regulator.
184.108.40.206. After completion of the operation switch ‘OFF’ the main and turn OFF water.
220.127.116.11. Tie the poly bag properly and close the container.
18.104.22.168. Affix ‘To be Cleaned’ label on the equipment after completion of the operation.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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