PFS Application
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作者:pmo90dc87
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发布时间 :2018-08-15
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2170 次浏览:
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Non-destructive vacuum decay method for pre-filled syringes closure integrity testing
Pharmaceutical Pre-Filled Syringes (PFSs) are currently used across a wide range of sectors such as biopharmaceuticals and vaccines; the market has moved in this direction for a number of reasons, including ease of drug administration, additional safety, lower risks of contamination and mix-up. One key aspects of PFS quality control is the assurance of closure integrity after fi lling and terminal sterilization. Leaking through the PFS may expose its drug product to the lack of sterility assurance. This article, serves to explore the validation of a non-destructive Container Closure Integrity (CCI) testing technique applicable to PFSs, fi lled in with vaccines manufactured by a global leading pharmaceutical company. Data and fi ndings of a challenge test performed as stated in ASTM F2338, a FDA Recognized Consensus Standard referred to pharmaceutical package integrity, are provided. All CCI tests employed the equipment model “LF-S”, manufactured by Bonfi glioli Engineering, located in Vigarano Pieve, Ferrara, Italy. The study demonstrates that LF-S is effective in detecting PFS leakages less than 5.0 μm in diameter by using the Vacuum Decay Method (VDM). A suitable test samples set was employed to determine the detection capability, the process sigma level and test effi ciency indicators. Besides, an innovative system preventing possible PFS plunger movement during CCI testing execution is presented.
