SOP Title: Operation, and Calibration of Metal Detector
- Objective:
To define procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Metal Detector.
- Scope:
This SOP is applicable to Metal Detector used for detecting metal particles in final product in Production Department.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance and Calibration of Metal Detector.
- Engineering Department: To perform preventive maintenance and calibration of Metal Detector.
- Quality Control Department: To analyse and report the swab/rinse samples.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the Preventive Maintenance and Calibration reports. To review and approve the SOP and Annexure.
- Accountability:
Head, Production Department, Head, Engineering Department and Head Quality Assurance.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance department or any personnel trained to perform duties as per this SOP.
- Quality Control Associate: Executive of Quality Control department or any personnel trained to perform duties as per this SOP.
- Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.
- In-Process Checks: As per the Scope of this SOP the In-Process checks refers to, checking sensitivity of Metal Detector.
- Non Recoverable Rejects: The Tablets/Capsules which cannot be re processed, for example, Tablets/Capsules rejected during the metal detection Non Recoverable Rejects are to be discarded.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
- Remove the previous batch residue.
- During end of the shift.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
- Type B Cleaning: Wet cleaning by using soap solution in the following cases
- Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
- Change in colour.
- Monthly ,if cleaned equipment not used for production activity.
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product.
- After cleaning validity before use, if cleaned equipment is not used for production.
- After replacement or repair of any product contact part.
- Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
- Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine
- Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
- Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed during production as mentioned in product BMR and also after repair or replacement of parts coming in direct contact with product.
- Definition:
5.2 Procedure:
| Precautions | ||
| 5.2.1 | Ensure that, equipment is cleaned and line clearance is taken as per respective BMR checklist. | |
| 5.2.2 | Switch ‘OFF’ the main power supply during machine setting, cleaning and product change over activity. | |
| 5.2.3
|
Allow the Metal Detector initially to stabilise at least for 5 minutes. | |
| 5.2.4 | Metal Detector chute should not be attached to any metal body during operation. | |
| 5.2.5 | Put “OFF” the mains of Metal Detector during cleaning. | |
| 5.2.6 | Do not wash inside surface, circuit channel of Metal Detector. | |
| 5.2.7 | After completion of metal detection, clean the standard metal chips (test samples) with moist cloth then dry with soft clean cloth. | |
| 5.3 | Operation | |
| 5.3.1 | Switch “ON” the electrical mains. | |
| 5.3.2 | Initially Metal Detector LED bar graph will start blinking with opening and closing of flap with glowing green and red colour indicator. | |
| 5.3.3 | Allow the Metal Detector to stabilize, till the red blinking of bar graph disappears. | |
| 5.3.4 | After stabilizing Metal Detector, green colour two bulbs will glow and flap will close with green colour “Power ON” indicator glowing. | |
| 5.3.5 | For sensitivity checking pass the test sample chips of ferrous 0.15 mm, non ferrous 0.25 mm and S.S. 0.25 mm test chips through Metal Detector chute one by one. | |
| 5.3.6 | During passing all the test chips should deflect (rejects) by opening the rejects flap. | |
| 5.3.7 | Place the Metal Detector below the outlet chute of de-duster or out let chute of compression machine or capsule filling machine or polishing machine as per the requirement. | |
| 5.3.8 | Pass the Tablets / Capsules through Metal Detector for detecting metal particles if any, present in the product. | |
| 5.3.9 | Collect the metal detected Tablets / Capsules in the clean containers lined with double poly bag. Affix ‘In Process Label’ to the container as per SOP. | |
| 5.3.10 | Tablets / Capsules should pass in uniform quantity and should not block the passage or detecting zone. | |
| 5.3.11 | The Metal Detector channel angle should be maintained as per product shape and size to maintain the uniform flow of Tablets / Capsules by passing the product through Metal Detector. | |
| 5.3.12 | During operation, Tablets / Capsules should freely pass through the Metal Detector. | |
| 5.3.13 | Check the Tablets/Capsules ejecting out from the Metal Detector for any defects. Record the rejection details in the product BMR. | |
| 5.3.14 | At the end of the metal detection or after regular intervals, all the deflected Tablets / Capsules should be removed from the rejection collection box and should be re- passed through the Metal Detector. | |
| 5.3.15 | The finally rejected Tablets / Capsule should be labelled as ‘Non Recoverable Rejects’. | |
| 5.3.16 | Weigh the metal detected Tablets/Capsules and rejected Tablets/Capsules for yield reconciliation. Record the respective weight in the BMR | |
| 5.3.17 | These rejections should be destroyed after proper authorisation from Production Head and QA. | |
| 5.3.18 | If any metal contaminated Tablets / Capsules rejection observed during compression / capsule filling, then stop the compression / capsule filling activity and check the metal source of the machine or friction of any metal part. | |
| 5.3.19 | After rectification, start the regular production activity. | |
| 5.3.20 | Standard limits: Metal particles should be absent in final product. | |
| 5.3.21 | At the end of operation, check the sensitivity of Metal Detector. If any discrepancy is observed, re-pass all the previously checked Tablets / Capsules through the Metal Detector. | |
| 5.3.22 | After completion of metal detection, switch “OFF” the Metal Detector. | |
| 5.3.23 | Clean the test chips and store them in the container provided. | |
| 5.3.24 | After completion of metal detection activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned” depending on use. | |
| 5.3.25 | Record the activity in equipment log book as per Annexure. | |
| 5.4 | Type A Cleaning | |
| 5.4.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.. | |
| 5.4.2 | Ensure that the electrical utilities to the Metal Detector are switched ‘OFF’ during the cleaning process. | |
| 5.4.3 | Dry clean the equipment with the help of Vacuum Cleaner or clean dry duster to remove the powder. | |
| 5.4.4 | Remove acrylic cover and wipe with clean dry duster. | |
| 5.4.5 | Dry clean the rejects collection box with dry clean duster. | |
| 5.4.6 | Ensure the cleanliness by checking visually for the presence of previous batch particles, then affix “Type A Cleaned” label. | |
| 5.4.7 | Record the activity in equipment log book as per Annexure . | |
| 5.5 | Type B Cleaning | |
| 5.5.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.5.2 | Ensure that the electrical utilities to the Metal Detector are switched ‘OFF’ during the cleaning process. | |
| 5.5.3 | Dry clean the Metal Detector with the help of Vacuum Cleaner or clean dry duster to remove the powder. | |
| 5.5.4 | Remove the Teflon Chute by pulling back and dismantle acrylic cover, dismantle the S.S. inlet chute by removing the hexagonal bolt then transfer these parts to the wash area by covering in poly bag with “To be Type B Cleaned” label. | |
| 5.5.5 | Wash the above parts with 0.1 % soap solution (teepol) prepared as per the SOP preparation of cleaning agent solution. Then wash with sufficient quantity potable water, finally rinse with purified water. | |
| 5.5.6 | Disconnect terminals of solenoid valve and disconnect the reject flap assembly and wipe its surface with soft clean moist cloth dipped in purified water then wipe with clean dry duster. | |
| 5.5.7 | After assuring cleanliness, dry the above parts with a clean dry lint free duster / compressed air. | |
| 5.5.8 | Assemble the dismantled parts in its place properly and label the equipment as “ Type B Cleaned”. | |
| 5.5.9 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department for collection of samples. | |
| 5.5.10 | Record the activity in equipment log book as per Annexure. | |
| 5.5.11 | Collect the Swab/Rinse sample result from Quality Assurance Department. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.5 to 5.5.6 | |
| 5.5.12 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.6 | Breakdown | |
| 5.6.1 | If breakdown occurs during operation, hold the dedusting and metal detection process. Inform to the Head Production. | |
| 5.6.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.6.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.6.4 | Unload the product only, if required for breakdown rectification. | |
| 5.6.5 | Store the unloaded tablets/ capsules in suitable closed container | |
| 5.6.6 | If breakdown occurs prior to start of operation, follow step 5.6.2 | |
| 5.6.7 | Record the breakdown activity in Equipment Log Book. | |
| 5.6.8 | After completion of repairs, the operations can be resumed. Perform “Type A or Type B” cleaning if the material has been unloaded from the machine. | |
| 5.6.9 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.6.10 | Record the repair completion activity in Equipment Log Book. Refer Annexure. | |
| 5.6.11 | Describe the breakdown activity in the respective product BMR. | |
| 5.7 | Preventive Maintenance | |
| 5.7.1 | Perform the Preventive Maintenance as per Annexure. | |
| 5.7.2 | If Preventive Maintenance activity is outsourced, the values are to be transcribed in the Annexure and external party certificate to be attached. | |
| 5.7.3 | Attach the Preventive Maintenance label on the equipment. | |
| 5.8 | Calibration / Sensitivity Checking: | |
| 5.8.1 | Sensitivity Checking: For sensitivity checking, pass the test chips of ferrous 0.15 mm, non ferrous 0.25 mm and S.S. 0.25 mm through metal detector chute one by one. All the test chips should get rejected by opening the reject flap. | |
| 5.8.2 | Frequency for Sensitivity Checking:
1. At the start and end of operation, in-between at regular intervals as mentioned in Batch Manufacturing Record. 2. After every switch “ON” or after resuming power. |
- Abbreviation :
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| PD | Production Department |
| TAB | Tablet |
| S.S. | Stainless Steel |
| CAP | Capsules |
| mm | Millimetre |
| BMR | Batch Manufacturing Record |
| QA | Quality Assurance |
| % | Percent |
| v/v | Volume by Volume |
| ml | Mili Litre |
| LED | Light Emitting Diode |
*Note – Ready to use SOP available in “DOWNLOAD” Section.