Prioritizing metal detector for finished pharmaceutical formulation: Manufacturing safe, quality product
1 Department of Pharmaceutics, MIT College of Pharmacy, MIT Group of Institutions, Moradabad-244001, Uttar Pradesh, India.
2 Department of Pharmaceutical Sciences, Kumaun University, Nanital-263136, Uttara Khand, India.
Research Article
World Journal of Advanced Research and Reviews, 2022, 16(03), 482-489
Article DOI: 10.30574/wjarr.2022.16.3.1339
Publication history:
Received on 01 November 2022; revised on 12 December 2022; accepted on 14 December 2022
Abstract:
Background: The pharmaceutical metal detector is a device to detect metal as well as non-metal contaminants of large size in the pharmaceutical dosage form. The detection of unwanted metal (contaminant) is important to produce a high quality of the dosage form.
Main body: Pharmaceutical dosage forms are highly sensitive to the environment to which they are surrounded. It is challenging to keep a product in its original form throughout its shelf life. These metals find entry in the pharmaceutical formulation during various phases of manufacturing while passing through pipelines, sieves, conveyors, wires, buds, error in mixing processes, through raw materials. The Food and Drug Administration Hazard Evaluation board has given that the length of 0.3 inches to 1 inch of metal is considered unacceptable. The article highlights source of the metal contamination in pharmaceutical formulation types of detectors used, FDA standard for the metal detector, the need for a metal detector with its ideal properties, effect, hazards of ingesting metal fragments through medicines, working principle, uses, separation of metal contamination, test for the metal detector go about when metal is detected. Monitoring of system in a metal detector at the Critical control points some case studies involve reputed pharmaceutical manufacturers, which were forced to recall the batches for metal fragments detected in finished product.
Conclusion: The pharmaceutical companies are bounded to produce quality safe products. One adulteration may cause recalls of products, cost loss of millions of dollar or total disruption of business as well. The selection of suitable metal detector is much needed. As the metal detector inclusively controls the contamination maintains a tough control on the quality of products.
Keywords:
Metal detector; Metal contamination; Quality; Safety; Hazards; Ferrous non-ferrous; Recall
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