Detecting Foreign Particles in Active Pharmaceutical Ingredients
Drug manufacturing is becoming increasingly regulated, and for good reason. With more and more pharmaceutical companies using third party manufacturers for their ingredients, ensuring they adhere to countries' strict standards is more important than ever.
The need for foreign body control when inspecting APIs (Active Pharmaceutical Ingredients) is increasing as countries adopt CEFIC (European Chemical Industry Council) standards.
APIs are the part of a drug that produces the drug's 'effects', and are often manufactured overseas rather than produced by the pharmaceutical companies themselves. This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put in place.
With the majority of API manufacturers based in India and China, more and more pharmaceutical companies are outsourcing their API production. However, regardless of where the API is made, companies must adhere to strict safety and quality standards set by the country where it will be used.
Product Inspection lies at the heart of these standards and whilst pharmaceutical manufacturers must adhere to the specified weights and measures and correct labeling, appropriate contamination prevention must also be in place for APIs.
According to CEFIC guidance, effective contamination detection and removal procedures must be implemented - atypical particles such as metal pieces tend to originate from materials, which accidentally or unintentionally come into contact with the product or process stream. For example, metal may be introduced as a result of equipment breakdown or maintenance, or through accidental personal effects such as jewelry entering the production stream.
Industrial pharmaceutical metal detectors provide a good solution in fully integrated product inspection and rejection systems for tablets, capsules, powders and granules, detecting all metal contaminant types, including ferrous, non-ferrous and even the most difficult-to-detect non-magnetic stainless steels. Metal detectors can also be integrated with existing production equipment to ensure any contaminated product is detected and removed from the production line. Specialized bulk metal detectors such as METTLER TOLEDO's Pharma GF-PRO metal detectors are ideally suited for API production, detecting as little as 0.39mm pieces of metal – below the 0.5mm acceptance limit.
Achieving regulatory compliance is essential for API manufacturers, if they are to continue producing APIs for the pharmaceutical industry. Having the right metal detection solution can make the difference between passing or failing to meet legislation and standards.