Standard Operating Procedure To Lay Down Procedure For Operation And Cleaning Of Colloidal Machine

by Pharmadocx Consultants

SCOPE :

The procedure of this SOP shall be applicable to production deptt.

RESPONSIBILITY:

Production Chemist

PROCEDURE:-

Machine Name : Colloidal Mill

The entire machine operation and cleaning is divided in three stages.

  1. Pre-operative cleaning and setting .
  2. Operation.
  3. Post-operative cleaning and equipments preparation.

STAGE-1

  1. The exterior of the machine is cleaned with dry cloth
  2. Electrical connection are restored by pulling the plug top into the socket
  3. The “machine ready for use” sticker is removed and sticker/tag showing product, batch no. etc. is put on the top cover of the machine.A plastic/S.S containers is kept below the outlet of the m/c.
  4. The container containing the material is brought near machine.

  STAGE-II

A . The colloidal with is switched on and run for few seconds to observe whether if is running normally or not.

B. If any abnormal sound is heard the machine is referred to maintenance dept. for rectification.

C. In other case the machine is started and the liquid is out the hopper slowly and gradually.

D. The colloidal liquid is collected in the s.s. Container.

E. The process is continued till the entire liquid is colloid.

F. If further colloid of the same batch is required it is continued.

G. In case of batch changes the contact parts are cleaned by water and then D.M.water.

STAGE –III.

  1. After the day’s operation or production change of composition all the contact  parts like hopper, pipe and grinding parts are thoroughly cleaned and wash water is sent to Q.C.D. for testing.
  2. Once the wash water analysis is cleaned by Q.C.D. the contact parts and other parts are moped and dried.
  3. The connection is then cut off by taking out the pug top from socket.A sticker stating “Machine ready for use” is put on the machine to render it ready for use.
  4. Logbook is kept for each machine of operation in the format given in annexure 1

                                          ANNEXURE -1

                                           Log Book

M/C: COLLOIDAL MILL Machine NO.                   

DateStart TimeFinish TimeTotal hrs. of runningBreakdown Start EndDown Time hrs.Product, Batch No, B Size, Mfg & Exp.Operator &  Checked By
Author: (Production Manager  )Checked by: (QA Manager)Authorized by: (Director Administration)
Date:Date :Date :

(Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

14 June 2023

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