Evaluating new hypodermic and intradermal injection devices.
The wicking spear gravimetric method was selected as the easier and the most consistent method for fluid leakage collection. The kit uses the glass sample collection tube to store the wicking spears before and after fluid leakage collection. It has been shown to provide reliable equipment for wicking spear intermediate storage and shipment to central laboratories for weight/mass measurements. Weighting the collection tubes with wicking spear inside, in a central laboratory in a batch fashion, before and after fluid collection, contributes to minimising operator and balance errors on method accuracy. The volume detection threshold is below 2 microL and the measurement error, even after 12 days of storage at room temperature, is below 1 microL, which is considered not to be clinically relevant.
Laurent
P E
PE
BD Medical, Pharmaceutical Systems, Medical Affairs, Le Pont-de-Claix, France. philippe_laurent@europe.db.com
Pettis
R
R
Easterbrook
W
W
Berube
J
J
D004867:Equipment Design; D004868:Equipment Failure; D007271:Injections, Intradermal / Q000295:instrumentation* / Q000379:methods; D014481:United States