Sterility validity period of vials after multiple sampling under vertical laminar airflow hood

Abstract

Study objectives. The aim of this study is to validate the sterility period of vials after multiple sampling under Grade A vertical laminar airflow hood.

Methods. Vials filled aseptically with a sterile culture medium have been sampled with syringes three times a week over one month under Grade A vertical laminar airflow hood and in the meanwhile, keeping the vials out of the laminar airflow hoods.

Results. No microbial growth has been observed. On the basis of these results, it has been decided to modify our standard operating procedures, to allow keeping the vials for two weeks in a box out of the laminar airflow hoods (ambient temperature Grade B) or any controlled environment (under refrigeration).

Conclusions. This study validates the multiple use of vials of small to large volumes (5-100 mL), to simplify handling and to reduce the costs in centralized cytostatic reconstitution units in hospital pharmacies, with no microbial risk.