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SOP for operation of Metal Detector for automatic capsule filling machine

SOP for operation of Metal Detector for automatic capsule filling machine

Objective:

To lay down a procedure for operation of metal detector.

Scope:

This SOP is applicable for the operation of metal detector to the formulation plant of  PHARMACEUTICAL Company.

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:       

Equipment Details:

  • Name of the equipment :       Metal Detector
  • Manufactured by :       Pam Pharmaceutical & Allied machinery.
  • Equipment Specification:
Equipment No. Capacity Electric Supply Location
80,000 to 1,20,000 capsules/hr 220 V, Single Phase, 50Hz

Pre-startup:

Visually inspect the machine and room for cleanliness.

Check the temperature and relative humidity of the area and record it in the environmental control record . 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.

Connect the electrical switch of the metal detector to the socket of the automatic capsule filling machine. Ensure the solenoid valve is connected to the system.

Put ON the power supply of the machine.

Operation:

  • Remove the “CLEANED” label from the machine.
  • Switch on the main supply, ‘PAM PHARMACEUTICAL & ALLIED MACHINARY CO. *MD 2000* displayed on the screen.
  • Pass metal embedded ferrous and non ferrous blocks through test coil.
  • Confirm detection of these metal blocks.
  • Check sensitivity setting, if required.
  • If rejection system operates after block reaches to rejection point, operate delay has to be increased.
  • If rejection system operates after block passing means operate delay has to be reduced.
  • Increase hold timing, if blocks do not gets rejected properly.
  • Ensure rejection of metal block after adjustment.

Adjust this delay optimum to ensure minimum rejection time since more products may get rejected for large hold delay setting.

  • Ensure repeatability of the system.
  • During operation, if contaminated product is observed, reconfirm its rejection by passing it once again through test coil.
  • Check its signal level on L.E.D. barograph.
  • Ensure proper functioning of the metal detector during operation.
  • Record the operation time of the machine in “Equipment Operation, cleaning & Maintenance Log Book”.
  • Affix “TO BE CLEANED” label to the machine.
    • Shutdown:
    • Put OFF the mains and affix “TO BE CLEANED” label on the machine.
    • Dry clean the machine with lint free duster.
    • Destroy the rejected capsules as per SOP. Record the same in BMR.

List of Annexure / Format:

Not Applicable

References (if any) :

Instruction Manual

Reason for revision:

Periodic revision.

Abbreviations:

SOP: Standard Operating Procedure.

No.: Number

BMR:Batch Manufacturing Record

QA.:Quality Assurance

E.D.:Light Emitting Diode

 

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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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