Metal detector system to eliminate metal particle containing tablets during manufacturing.
Question: How to remove metal particles if any which might be getting generated during manufacturing due to wear and tear of machines.
Answer: Source for Metal particles in a tablet dosage form may be one of following.
Raw material, Defective equipment, like broken sieve mesh, compression machine wear and tear.
Following care can be taken to eliminate the risk of metal particles getting entrapped in the tablet.
Addition of a test of magnet on raw material sample during testing and sampling, a magnet can be hovered over the sample or inside the raw material container during sampling, if there are any metal particles they will get attracted over magnet and can be detected, such raw material will get failed during sampling itself, same can be done during testing of sampled raw material. Visual inspection of sampled raw material for nonmagnetic metal particles is and black particle other contaminant is required to do.
Some sieves come with magnetic ring at periphery of the sieve by virtue of which the ferromagnetic metal particles can be removed during sieving or shifting of the raw material before addition in to the blender.
What to do even after this metal particle goes in to tablet unnoticed.
There are metal detectors available in pharmaceutical machinery manufacturers, these metal detectors are capable of identifying nonferrous or stainless steel particle of 0.5 mm and ferrous metal particle of size 0.3 mm. This metal detector equipment’s when placed below the compression machine chute, collecting the tablets, tablets when run through the metal detector a tablet with nonmagnetic or nonferrous metal particle are detected and removed away in the rejection bin, these can be destroyed later on. The speed of the metal detector depends up on the size of tablet, for smaller tablets it can process about 5000 to 6000 tablets in a minute for tablet of weight up to 350 mg 10000 tablets for tablets below 250mg, while for bigger tablets it will be 3000 to 5000 tablets, one can add additional metal detector for higher output. Manufacturer can enhance the capacity.
Why alarm system is put on the metal detectors systems.
Alarm system get activated when a tablet with metal is detected and removed away from the good tablets, the alarm is for alert for the supervisors and pharmacists working for taking further precautions if required.
Validation Verification Challenge test of metal detector system:
Before starting of the operation on daily basis a test is designed to challenge the metal detector by sending a tablet with metal particles of ferrous 0.3 mm size, nonferrous 0.5 mm size.
System can be validated by adding known number of samples of tablets in the tablets being inspected and crosschecking if the metal detector can remove the added tablets, if the metal detector removes all tablets with metal particle successfully is verified, up on successful run on three consecutive batches the equipment can be said to be validated to remove metal particles in the tablets.