OPERATING PROCEDURE FOR METAL DETECTOR

OBJECTIVE:

To lay down a Procedure for Metal detector.

SCOPE:

The scope of this SOP is procedure for operation of Metal detector.  

RESPONSIBILITY:

Initiator Executive/Designee: Production shall ensure the compliance of the SOP

Initiator Officer/Designee: Production shall perform the operation activity as per SOP.

ACCOUNTABILITY:

QA Head shall be Accountable for implementation of SOP.

ABOUT METAL DETECTOR:

Metal detectors are crucial in the pharmaceutical industry to ensure product safety and quality. These devices utilize electromagnetic fields to detect the presence of metallic contaminants, such as fragments of machinery or foreign objects, within pharmaceutical products like tablets, capsules, and powders. If a metal particle is detected, the system automatically rejects the contaminated product, preventing it from reaching consumers. This rigorous quality control measure is essential to maintain the integrity and safety of pharmaceutical products.

OPERATION:

For the Existing Product:

• For the product which have recipe stored already, go in “set up” function, Display will show “product library.”
• Press the “enter key”. From the product library select the product by pressing arrow keys.
• After selecting the product, press “enter”. Display will show select as a “New Active Product”.
• Then press “enter”. Now the machine is ready to run the selected product.

For a New Product:

• For a new product go in “set up” function with the help of arrow keys, then go in “product settings,” then press Enter. Display will show “product name” on first line and “Select, Edit, and Delete” option on second line.
• Select “Edit” operation and press “Enter”. Then Enter “Login ID” and “Password” of supervisor level.
• Now Display will show “Enter the product name”. 
• Enter the product name by using arrow keys. Press “enter”.
• Now enter the “Batch No.” by using the arrow keys.
• Go in “Set up” function by using arrow keys. Then go in “auto “setting”.
• Select the product from product library. Press “Enter” , Display will show “want to verify dry product phase?”, then press “enter”.
• Pass the blank sample, press “enter”, Display will shows “Please wait processing data” Followed by “Auto setting starts, Pass the product within 20 seconds”.
• Pass the capsules within 20 seconds.
• After 20 seconds display will show “auto setting completed, loading parameters”. Depending upon product shape / size, conveying speed, and reject collection system adjusts delays.

Challenge Test for Metal Detector:

• Pass the standard test blocks of Ferrous, Non Ferrous and Nonmagnetic steel one by one.
• Metal detector shall reject all three blocks.
• Note: If any standard block is not rejected, PNC shall be initiated and investigated as per the SOPand send job work orders to the engineering department for rectification.
• Adjust the height and angle of the metal detector such that the inlet chute of the metal detector is adjusted below the outlet chute of capsule discharge chute.

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• Allow the product to pass through metal detector.
• Whenever metal contamination is detected in Capsule metal detector gives test head annunciations in the form of audio buzzer and capsule get collected in reject bowl attached below the discharge chute.
• In case any metal contamination is found inform to QA department, PNC shall be initiated and investigated as per the SOP. 
• Restart the operation only after closing of PNC. 
• Ensure that no overloading of the capsules occurs.
• After completion of the metal detector challenge test wipe all the blocks of Ferrous, Non Ferrous, Non Magnetic Steel and Blank sample with lint free cloth, followed by wiping with wet lint free cloth dipped in purified water. Finally wipe with lint free cloth dipped in 70 % Iso Propyl Alcohol.

Frequency of Challenge Test:

• Challenge test shall be performed during every start.
• At the frequency of every eight hours of continuous operation.
• After completion of batch.
• If any breakdown or power interruptions in-betweens.

REFERENCES:

Not Applicable

ANNEXURES: 

Not Applicable

ENCLOSURES: SOP Training Record.

DISTRIBUTION:

Controlled Copy No. 01  :          Head Quality Assurance

Controlled Copy No. 02  :         Head Production

Master Copy                    :          Quality Assurance Department

ABBREVIATIONS:

REVISION HISTORY:             

CHANGE HISTORY LOG

Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/operating-procedure-for-metal-detector/