|
Peter Austin, MSc, MRPharmS, is senior pharmacist
and Stephen Dixson, BPharm, MRPharmS, is principal pharmacist at
Southampton General Hospital.
Correspondence to: Mr Austin at Pharmacy Department, Southampton
General Hospital, Tremona Road, Southampton SO16 6YD
e-mail Peter.Austin@suht.swest.nhs.uk |
Abstract
Aim
To determine the microbiological relevance of syringe hub fluid to product
integrity during storage.
Design
Aseptic preparation of 1,002 luer-lock syringes under European Community
Good Manufacturing Practice (EC GMP) Grade A conditions with (500)
and without (502) a hub fluid reservoir subsequently stored for 28
days in
an uncontrolled environment followed by a determination of microbiological
contamination of each syringe hub and fill. Positive and negative controls
were used to ensure the specificity and selectivity of results. Outcome measures
Level of microbiological contamination of the syringe hub and syringe
fill. Results
The 500 syringes with hub fluid showed microbiological contamination
in 2 hubs and no fills. The 502 syringes without hub fluid showed microbiological
contamination in 4 hubs and no fills. No statistically significant difference
in contamination of syringe hubs (P=0.687) or syringe fills
(P>0.05)
was detected but a statistically significant difference between syringe
hubs and syringe fills was found (P=0.031). Conclusions
This study demonstrated that the presence of hub fluid did not increase
microbiological contamination of syringes stored for up to 28 days.
The microbiological contamination of syringe hubs appears greater
than syringe
fills after a storage period of 28 days (P=0.031). |
The
Pharmaceutical Journal