Sterility validity period of vials after multiple sampling under vertical laminar airflow hood.
J Oncol Pharm Pract
; 11(2): 57-62, 2005 Jun.
Article
em En
| MEDLINE
| ID: mdl-16460606
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 mean-while, 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.
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Coleções:
01-internacional
Temas:
Geral
Base de dados:
MEDLINE
Assunto principal:
Ventilação
/
Esterilização
/
Embalagem de Medicamentos
Limite:
Humans
Idioma:
En
Revista:
J Oncol Pharm Pract
Assunto da revista:
FARMACIA
Ano de publicação:
2005
Tipo de documento:
Article
País de afiliação:
Suíça