Inspection technology for insulin cartridges: putting safety and quality first

摘要

Nevertheless,there is also good news: new therapies have turned a once deadly disease into a chronic one and pharmaceutical companies are making insulin available across the globe.To maintain the stringently high safety and quality standards required,insulin producers need both sophisticated filling technology as well as advanced inspection systems to protect both product and patients.Human insulin is obtained from bacteria using biotech-based methods.Since 1996,modified insulins have also been approved.Referred to as insulin analogues,they work particularly quickly or uniformly.During the past few years,insulin analogue patent expirations have triggered the market entry of biosimilars in many countries,leading to different manufacturing processes and stricter inspection requirements.Insulin is delivered either as a solution or as a suspension.Whereas a solution is a homogenous mixture in which one substance is dissolved in another and cannot be separated,a suspension is a mixture of liquids with solid particles that may not dissolve in the liquid.The latter presents a challenge during visual inspection.In the treatment of diabetes,pen systems that can be equipped with insulin cartridges and injection needles have long surpassed all other delivery systems,mainly because of their ease of use and relatively inexpensive production.The insulin pens are loaded with cartridges-a glass cylinder that is closed on the top end by an aluminium cap with a puncture membrane and,at the bottom end,with a rubber stopper.Although easy and safe handling are the most important criteria for patients,insulin manufacturers must pay particular attention to sterile filling and to the integrity of both the product and the packaging materials used.