Hospital preparations : towards the automation of their packaging

N. Kervella, A. Bourges, M. Bernard, S. Vrignaud, V. Lebreton
CHU d’Angers, France

Introduction
In order to optimize the mass packaging of some hospital preparations, the use of the Baxa Repeater® peristaltic pump is interesting, in particular to allow : an improvement in productivity, a reduction in musculoskeletal disorders, as well as the accuracy and the precision of the delivered volumes. Although this pump is selled qualified, it is essential to evaluate the factors that can affect volumetric pumping, such as the pressure exerted by the presence of a device (filter, needle…) at the end of the transfer tubing, in order to validate the entire process.

Objective
To qualify various packaging processes in order to integrate them into our routine.

Methods
The accuracy of the delivered volumes was evaluated by gravimetry using a precision balance (98-102%). Repeatability was assessed by performing these tests over 3 days with the calculation of the coefficient of variation (<5%). Three speeds were tested and two processes were qualified :
* Aseptic Reconditioning (AR) (3 x 10 measurements) from a 0.9% NaCl bag – 10.6 ml : a filter (maximum filtration = 100 ml) was placed at the end of the tubing. It was changed every 9 vials.
* Eyes drops packaging (EDP) (3 x 6 measurements) – 5 and 10 ml : the inlet of the tubing (2 diameters tested) is plunged into the receiving bottle of a Stericup® (vacuum filtration system) of 250 and 1000 ml, with or without needle. The latter was used to try to recover a maximum of volume. A comparison between manual and semi-automatic methods was performed.

Results
* AR : repeatability conforms, accuracy does not conform at high speed (e.g. 104,8 %). During the first use of the filter, a decrease of the desired volume is observed (dead volume), but remains in conformity (10.6 ml +/- 5%), except for a measurement at high speed (9.3 ml).
* EDP : without needle the precision is in conformity, but the accuracy is not in conformity for 1 measurement at high speed (93.5%). With needle, the accuracy is not in conformity when the small diameter tubing and the Stericup® 1000 ml are used ; and the accuracy is almost never in conformity.

Discussion/Conclusion
* AR : at high speed, the use of a filter does not allow to obtain compliant results.
* EDP : the use of a needle leads to a non-conformity of the delivered volumes and a risk of injury (jumping out of the vial). The large diameter tubing has a better hold in the receiving vial.
A minimum threshold of vials to be produced should be established in order to observe a time saving, or even an economic saving once the purchase of the pump has been amortized, because the number of syringes used increases with the number of vials to be packaged, contrary to the number of tubings (always = 1).
The results were obtained on a lab bench, a qualification of performance in real conditions will have to be realized.

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