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SOP for operation of de-dusting and polishing machine

SOP for operation of de-dusting and polishing machine

Standard Operating Procedure (SOP)

Objective

To lay down a procedure for operation of de-dusting and polishing machine.

Scope

This SOP is applicable for operation of de-dusting and polishing machine used to polish the Filled Capsules in Capsule Filling Area to the formulation plant.

Responsibility

  • Production Operator/ Technician – For operation of the machine.
  • Production Officer/Executive-To ensure that operation of the machine is carrying out as per procedure.

Accountability

Production Head shall be accountable for compliance of SOP.

Procedure

Pre-startup

  • The Production Executive/ Officer shall visually inspect the machine and room for Ensure that the area and equipment are free from remains of previous batch or product and the BMR of previous batch or product.
  • Remove the “CLEANED” label from the machine.
  • Affix the “EQUIPMENT STATUS” label on the machine.
  • Check the temperature and relative humidity of the area and record it in the environmental control record as per SOP. If it is within the specification as per the BMR, continue the operation. If not, do not start the operation and inform the Production Executive / Officer or Maintenance Department.
  • Put on the power supply of the Machine.
  • Ensure the Compressed air supply to the Machine.
  • Ensure the Vacuum supply is available for dust extraction unit.
  • Connect the pipe of dust extractor to the machine.
  • Switch on the dust extractor to remove the powder from the machine during operation.

Equipment Details

  • Name of the equipment :       De-Dusting and Polishing Machine
  • Manufactured by :       Pam Pharmaceutical & Allied Machinery.

Equipment Specification

Equipment No. Capacity        Location
100000Capsules/Hr. Capsule Filling-I
  • Operation
  • Switch on the mains of the machine by main switch. The main ON (Red) LED will glow indicating main supply.
  • Press the Red push button to start the motor. The motor ON (Green) LED will glow indicating supply to the motor.
  • Slowly turn the potentiometer knob clock wise and set it at required speed.
  • Start compressed air supply and set the pressure regulator at 5kg/cm² Pressure.
  • Start feeding the capsules from the inlet hopper at a uniform rate.
  • Check the polishing quality of the capsule. If the quality is not satisfactory then vary the speed of the brush.
  • The polished capsule then passes through the filled capsule sorter.
  • Record the operation time of the machine in “Equipment Operation, cleaning & Maintenance Log Book” as per SOP .
  • Affix “TO BE CLEANED” label to the machine.

Shutdown

  • Switch off the mains of the machine by Main switch.

List of Annexure / Format

  • Not Applicable

References (if any)

  • SOP on monitoring of temperature, RH and pressure differential

Reason for revision

  • New SOP

Abbreviations

  • SOP :           Standard Operating Procedure
  • LED :           Light Emitting Diode
  • BMR :                Batch Manufacturing Record
  • Kg:                Kilogram
  • Cm­2:                Centimeter square
  • Hr :                Hour

END OF SOP

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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