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Tuesday, February 7, 2023

Metal detector for tablet and capsule Validation and 21 CFR Part 11 requirements

How to remove a tablet or capsule with metal fragment accidently incorporated in to it?
If proper care is not taken to eliminate metal particles from the tablet dosage form it can lead to serious health issues, also it can lead to serious FDA regulatory actions against manufacturers. It is important to incorporate metal detectors for pharmaceutical use at point of compression, and at any suitable point as per requirement. 

How can a metal particle get into the capsule or tablet dosage form
Metal particles may have originated during processing of raw materials API or excipients used in tablets, or due to wear and tear of compression machines or accidental breakdown of punches or machine parts.
Metals are used during synthesis as catalysts, and metal mesh screens are used for sieving the material, in event of load or pressure these metal wires of screen may get broken and can get into the product. To eliminate the metal particles from the product, metal detectors are used. Metal detectors have become an integral and important part of tablet dosage form manufacturing.

Metal detector: Neutralizing signal due to vibration, and false detection. Vibration and inverter noise signals get super imposed on the foreign particle signal and lead to false detection, and error of false metal detection. Metal detectors should attenuate the signal from vibration. High stability device is required. 

False detection due to static charge build up on chute: The tablet guide chute gets static electric charge developed over the chute which can lead to false detection signal over the pharma metal detector

Sensitivity of metal detector: It should be highly sensitive to nonferrous and ferrous metal particles even in vibration of devices, it should be able to detect minute metal particles in the tablet and capsule dosage form. Size of metal particles which can be detected by a metal detector used for tablets dosage form and capsules is 0.1 micrometer for ferrous and 0.2 micrometer for nonferrous metal particles.

Validation of Metal detector: Samples of known metal particle size and both ferrous and nonferrous metal particles of size 0.1 micron and increasing up to 0.5 micron are taken for making a tablet sample for challenging the metal detector.

Data should be recorded for the particle size which the metal detector detected and rejected successfully. Invent of non-rejection of a rejected sample it should be verified for the cause of non-rejection, and a correction should be done so that metal detector does not pass the metal particle containing sample tablet in repeated challenging. 

Various speeds of operation should be studied during validation of metal detector and an optimum speed at which the metal detector gives perfect operation should be selected for routine production. There should be a mechanism in the metal detector for identifying the tablet with metal particles in event the rejection arm does not capture the sample, there should be an additional detector placed at the dropping point for good tablets, which verifies the accidental entry of the rejected tablet into good tablets.
21 CFR Part 11 compliance requirements for metal detector:  Important aspects of 21 CFR part 11 computerized systems are applicable to metal detectors, the HMI should be provided with three levels of password protection system. Operator should be allowed to do operations, the supervisor should be allowed to do only observations and the manager is allowed to do entries. The data should be available with audit trial and logs. Data should be protected so that it cannot be modified by any one. 
Metal detector should be able to log all the events of a metal particle containing a tablet or capsule. 
Metal detectors should be able to display which kind of metal particle it has detected, nonferrous or ferrous, this completely depends on magnetic properties of the metal, metal detectors can detect even aluminum and bronze and SS 316 metal particles along with ferrous metal particles.
Which metal detectors are best.
Aneritsu's metal detector is a good in performance and compliance aspect.

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