PDA TR 73

PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications discusses the requirements for the 1 mL long glass prefilled syringe (PFS) for biotechnology applications. Over the past decade, a large number of subcutaneously injected biotechnology drug products have been packaged in PFSs because of the benefits compared to vials or ampules. The benefits of PFSs include reduction of medical dosing errors, reduction in risk of microbial contamination by decreased manipulation prior to injection, and improved compliance due to ease of use. In addition to the patient benefits, PFSs often have lower overfill regulatory requirements than vials, thereby reducing product waste. This report provides guidance on material selection and evaluation for suitability, syringe preparation and handling (including human factors), and drug product compatibility (physical and chemical) with the syringe materials and mode of delivery. Plastic syringes and ancillary devices, such as autoinjectors, are not within scope.