Mitigating Particulate Risk In Injectables

By Tibor Hlobik, senior director, product technology services, and Ravi Patel, director, quality engineering and metrology

The rising prevalence of chronic diseases has driven the global injectable market up from $148bn to $581bn (2018-2022), mainly brought about by sterile injectable biologic drug products.¹ Illnesses driving this growth are predominantly cancer, diabetes, and cardiovascular and other auto-immune conditions.¹ Commercial treatments are delivered to patients primarily in a sealed vial, prefilled syringe with/without an auto-injector, or pre-filled cartridge in a device.

Drug manufacturers face increased pressure to minimize patient risk, which requires a robust, holistic control plan and a continuous improvement mindset, to achieve the highest quality and safety. One important aspect is the control of visible particulates in injectable drug products. Having visible particulates in a parenteral product can cause patient harm, but removing them can be challenging. FDA draft guidance, titled ‘Inspection of Injectable Products for Visible Particulates’, which is undergoing industry review, along with the latest European Good Manufacturing Practice (EU GMP) Annex I revisions, must be taken into account.²

Choosing high quality, elastomeric components is an essential part of an effective contamination control strategy, and elastomer manufacturers are leading the industry’s efforts to develop innovative solutions for addressing particulate testing needs with new products.