Background and Importance Closed system transfer devices (CSTD) were originally designed to protect operators from cytotoxic, mutagenic, and reprotoxic agents. There is increasing pressure to reduce cost burden by preserving drugs, especially in the field of oncology. One solution is drug vial optimisation, which can be accomplished by extending the practical beyond use date of drug vials, through use of CSTDs.
Aim and Objectives This study aimed to test if the ChemfortTM CSTD can maintain microbiological integrity after 10 withdrawals from vials over a period of 28 days.
Material and Methods Tests were performed in both a controlled GMP Class A environment and an uncontrolled environment (350 vials in each environment). Environmental conditions were monitored by continuous air sampling. The rubber stoppers of all vials, containing tryptic soy broth (TSB) growth medium, were disinfected prior to mounting ChemfortTMVial Adaptors (VAs) on the vials. The ChemfortTMSyringe Adaptor (SA) was attached to a 10 mL syringe and subsequently connected to the VA. The septa of both the VA and SA were disinfected prior to every connection. Ten 5 mL aliquots were withdrawn from each vial at 2-week intervals (days 0/3 syringes, 14/3 syringes, and 28/4 syringes), incubated for 7 days at 20–25°C and then 7 days at 30–35°C. After 28 days, the vial containing the remaining growth medium (50 mL) was also incubated for 7 days at 20-25°C and then 7 days at 30-35°C. Vials and syringes were inspected visually for signs of microbial growth during each incubation. Ten positive control containers were subjected to a growth promotion test.
Results No signs of microbial growth were observed in any of the 7,000 samples, nor in the growth medium remaining in the vials after transfers were performed in either an uncontrolled or controlled environment.
Conclusion and Relevance The data presented demonstrates the ability of the tested CSTD to maintain microbiological integrity and support the decision to extend the practical in-use shelf life of drug products for up to 28 days when used with ChemfortTM in either aseptic conditions or uncontrolled conditions.
References and/or Acknowledgements 1. This research was supported by Simplivia Healthcare Ltd., Israel, and B. Braun Austria GesmbH, Austria.
Conflict of Interest No conflict of interest
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.