This document specifies the method principle, test instrument, test process, result calculation and test report for the determination of particulate contamination of disposable sterile syringes by photoresist method. This document is applicable to the use of photoresist method to determine particle contamination of single-use sterile syringes with particle sizes of 10 μm and above.
T/AHPPA 1-2023 history
2023T/AHPPA 1-2023 Determination of particulate contamination for disposable sterile syringe— Light obscuration method