Overview on new USP <382> and its impact on parenteral product packaging and delivery systems

Vikrant Chadawar, Sr Technical Account Specialist, West Pharma India, began his presentation with an introduction to USP <1382> and <382>, that was released in December 2020 with a five-year implementation grace period. He said that according to USP, the quality of medicine and how it is delivered to patients is fundamental to treating illness and maintaining health. He also shed some light on the difference between USP <381> and USP <382>.

“While <381> focusses more on penetrability, fragmentation and self sealing capacity, <382> focusses more on penetration force, needle self sealing capacity, plunge seal integrity, etc,” he informed. He also emphasised that needle self-sealing capacity is important, so that any random particle doesn’t enter into the product.

Apart from it, he mentioned that testing standards help in discovering risks, closing knowledge gaps, and packaging specifications will continue to evolve with advancing therapies and novel delivery systems. Later on, he mentioned about a PFS device and cartridge pen injector which assesses risks, knowledge gaps and essential performance requirements.

Focus additions beyond USP <382> include fill finish (system deliverable volume, head space and plunger placement, septum/stopper crimping quality, tip cap placement and security and particle contamination), environmental conditioning (distribution environment conditions, performance over time in conditions, pre-conditioning: cold, standard, warm) and shipping simulation (altitude simulation and transit distribution cycle simulation), he noted.