Microbiological Protocol for the Integrity Testing of Syringes, 2nd Edition, April 2013 (Yellow Cover)

Kathryn DaviesSource NHS Pharmaceutical Quality Assurance CommitteePublished

Disposable syringes are regularly used as final containers for aseptic products prepared within hospital units. This protocol is intended to describe standardised and validated methods for the assessment of the integrity of individual syringe/hub combinations used in Pharmaceutical Technical Services.

The following points should be taken into account by units using disposable syringes/closure systems as containers:

  • Luer-lock closures provide a more secure and integral closure than luer slip. For this reason luer-lock syringes are preferred. Where luer-slip syringes are used, a documented risk assessment to the justify use of luer slip is advised.
  • Flexing or bending of the extended plunger after filling, for example during storage and transport, should be avoided. This is known to produce problems with pack integrity.

Syringes, therefore, should not be filled to their full extent in order to help minimise the potential for leakage due to excessive sideways pressure applied the plunger during storage or transport*.

The preparation process should include a check to ensure a firm fit of syringe and hub for each individual item.

*

A useful “rule-of-thumb” is that the syringe, when used as a storage container, should not be filled to more that 85% of its nominal capacity.

e.g. 50ml for a 60ml syringe; 25ml for a 30ml syringe; 8.5ml for a 10ml syringe; 4ml for a 5ml syringe; 1.7ml for a 2ml syringe or 0.85ml for 1ml syringe

 

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