Blog

Standard Operating Procedure (SOP) for cleaning and operation of Mechanical Stirrer used in granulation at drug product manufacturing in pharmaceuticals.

SOP for Cleaning and Operation of Mechanical Stirrer

1.0   PURPOSE:

• • The purpose of this SOP is to lay down the cleaning and operation procedure for Mechanical Stirrer.

2.0   SCOPE:

• • This SOP is applicable for the cleaning and operation of the Mechanical Stirrer installed in the granulation section of the production department at the drug manufacturing plant.

3.0   REFERENCES:

• • Instruction Manual

• • SOP  for “ Type A & Type B Cleaning

• • SOP  for “Line Clearance of Area and Equipment”

4.0   RESPONSIBILITY:

• • The operator shall be responsible for the operation and cleaning of the machine as per the defined procedure.

• • Production Supervisor shall ensure cleaning and operation as per defined procedure, provide training to the new operators before involving in operation and maintain all necessary records.

• • Department Head or Designee shall be responsible for the follow-up and review of the SOP.

• • Quality Assurance shall be responsible for the Compliance and approval of the SOP.

5.0   ABBREVIATIONS USED IN SOP FOR MECHANICAL STIRRER:

• • BMR: Batch Manufacturing Record (Click here for SOP)

• • Dept: Department

• • IPA: Isopropyl Alcohol

• • NA: Not Applicable

• • NLT: Not Less Than

• • QA: Quality Assurance

• • SOP: Standard Operating Procedure

7.0   PROCEDURE – OPERATION AND CLEANING OF MECHANICAL STIRRER:

• • Checks & Precautions – SOP for Mechanical Stirrer:

• • Wear hand gloves and mask while working.

• • Maintain the equipment sequential log.

• • Cleaning Procedure of Mechanical Stirrer :

• • Product to Product Cleaning Procedure:

• • Ensure that ‘To be Cleaned’ label is affix on the equipment.

• • Switch ‘OFF’ the mains of the Stirrer.

• • Remove the stirrer shaft from stirrer and then clean with NLT 2 liters of potable water.

• • Then scrub the stirrer shaft with half liters of 2% non-ionic detergent solution using the scrubber to remove the adhering materials.

• • Wash the stirrer shaft with NLT 2 liters of potable water to remove adhered materials and non-ionic detergent solution.

• • Finally, rinse the stirrer with NLT 2 liters of Purified Water.

• • Wipe out the Stirrer body and regulator with dry cloth or dry with compressed air.

• • After ensuring the satisfactory cleanliness production personnel Intimate to QA, for line clearance.

Note:    The cleaning of the equipment remains valid for 48 hours. If the equipment is not     used within 48 hours, then it should be re-cleaned thoroughly before use.

• • Batch to Batch cleaning procedure:

  • Ensure that the ‘To be Cleaned’ label is affix on the equipment.

• • Switch ‘OFF’ the main of the stirrer.

• • Remove the stirrer shaft from stirrer and then clean with NLT 2 liters of purified water.

• • Wipe the body with the dry cloth or dry with compressed air.

• • Check for the cleanliness of the Stirrer.

• • After completion of the cleaning of Area and Equipment as per defined procedure, fill the details in Line clearance record / Sequential log.

Note:    The cleaning of the equipment remains valid for 48 hours. If the equipment is not used within 48 hours, then it should be re-cleaned.

• • Operating procedure of Mechanical Stirrer:

• • Affix ‘Under Process’ label on the Mechanical Stirrer equipment.

• • Switch ‘ON’ the main of the Mechanical Stirrer.

• • Ensure the proper fix of the dismantled stirrer shaft into the Mechanical Stirrer.

• • Place the container in which solution to be prepared, below the Mechanical Stirrer.

• • Adjust the stirrer blade in such a way that the blade deep in the Liquid materials/Solvent.

• • Ensure the stirrer shaft should not friction with the solution container.

• • Switch ON the Stirrer and regulator to start the rotation of Mechanical stirrer shaft.

• • Adjust the RPM of stirrer shaft as per requirement by adjusting the knob on the regulator if available.

• • Start solution preparation as per BMR.

• • Switch ‘OFF’ the Stirrer after completion of solution preparation.

• • Switch ‘OFF’ the main electric supply.

Note:    Clean the stirrer shaft and motor after processing of each lot/ operation with purified water to remove all deposited binder material.

• • Remove the ‘Under Process’ label.

• • Affix ‘To be cleaned’ label on the equipment.

• DISTRIBUTION:

• • Production

• • Quality Assurance

• ANNEXURES: NA