Recently
released - 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.
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.
Posted by Tim Sandle
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