SOP for Cleaning of Mini Roll Compactor : Pharmaceutical Guidelines

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SOP for Cleaning of Mini Roll Compactor

Standard operating procedure for cleaning of Mini roll compactor in pharma manufacturing.

1.0 OBJECTIVE:

To lay down the cleaning procedure for Mini roll compactor.

2.0 SCOPE:

This SCP shall be applicable for Mini roll compactor used in manufacturing area at Production department.

3.0 RESPONSIBILITY:

3.1 Execution :Operator
3.2 Checking :Pharmacist and Above

4.0 ACCOUNTABILITY:

HOD-Production

5.0 PROCEDURE:

5.1 Put “OFF” the electrical supply.
5.2 Remove the four hex bolts on the top plate.
5.3 Close the roller valve provided below the top plate at the same time open the Feed Screw (auger valve).
5.4 Close the hydraulic pump valve and pump it by the help of handle for lifting the variation assembly for removal of hopper.
Note: Do not lift beyond the danger mark, marked on the piston column.
5.5 Turn the variation plate sideways to have space for removing the Hopper.
5.6 Dismantle the hopper by loosening the wing nuts.
5.7 Dismantle the feed screw (auger) by loosing tie bolt provided on the top of reduction gearbox fixed on variation plate, while removing the tie bolt hold the feed screw (auger) otherwise, chance of feed screw falling down there.
5.8 Wipe out the residues using lint free cloth.
5.9 Clean the sides and base of the Mini roll compactor with 20 liters of Potable water and 2.5% “Teepol” solution at least two times till the residue is washed off.
5.10 Clean the rolls of the Mini roll compactor with 20 liters of Potable water and “Teepol” solution at least two times till the residue is washed off.
5.11 Clean all the removed contact parts with Potable water and 2.5% “Teepol” solution.
5.12 Clean thoroughly with Potable water to remove the detergent completely.
5.13 Apply steam to the removable parts thoroughly.

5.14 Finally rinse all the parts with about 25 liter of purified water.
5.15 Wipe the parts with clean dry lint free cloth and then with 70 % v/v solution of Isopropyl Alcohol (IPA).
5.16 Assemble the machine. Cover the hopper & delivery chute with polythene bags.
5.17 Affix “Cleaned” label and fill the “Equipment Log Book”.
5.18 Re-cleaned if not used within 72 hours.

6.0 ABBREVIATIONS:

IPA :Isopropyl Alcohol
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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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