Standard Operating Procedure for Uphill Deduster & Metal Detector.
1.0 Purpose
The purpose of this SOP is to establish a standard procedure for operating the Uphill Deduster & Metal Detector.
2.0 Scope
This SOP is applicable for the Uphill Deduster & metal Detector in
tablet compression area of the production section.
3.0 Responsibility
3.1 Machine Operator is responsible for operating the Uphill Deduster & Metal Detector.
3.2 Production Officer is responsible for the implementation of this SOP.
3.3 The Head Of Production is responsible for ensuring the implementation of this SOP.
3.4 Q.A. Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Production Pharmacist will ensure that the Uphill Deduster & metal Detector is properly cleaned.
4.2 Production Pharmacist will ensure that the Uphill Deduster & Metal Detector
and Area is labeled with Cleaned label status.
4.3 Before starting the operation of the Uphill Deduster & metal Detector, take line clearance from the QA officer and affix product-related labels to the Uphill Deduster & metal Detector and Area.
4.4 Attach compressed air pipes & vacuum suction pipes to the relevant points or ports of the Uphill Deduster & metal Detector.
4.5 Attach the inlet point of the Uphill Deduster & metal Detector to the discharging chute of the compression machine.
4.6 Insert the plug of wire to the compression machine port or to the external wall mounted socket.
4.7 Press the ON button and adjust the speed of vibrations and compressed air pressure.
4.8 Before starting the operation perform a challenge test of the metal detector.
4.9 If the challenge test is passed, place a tablet/product collection container below the discharging port of the Uphill Deduster & Metal Detector.
4.10 Start the compression machine and allow tablets to pass through the Uphill Deduster & Metal Detector.
4.11 Adjust the speed of vibration & air pressure if required.
4.12 When all tablets are compressed & passed through Uphill Deduster & metal Detector stop the compression machine.
4.13 Check the rejection box of the metal detector & remove any metal-containing tablets if present.
4.14 Remove the product container and transfer it to the relevant staging area.
4.15 Attach to be cleaned label to the Uphill Deduster & Metal Detector.
4.16 Record the activity in the logbook of the Uphill Deduster & Metal Detector.
and sign it.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 BMR: Batch Manufacturing Record
5.3 QA: Quality Assurance
5.4 HOP:Head Of Production
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