Validation of a visual inspection table with training and accreditation of operators for the control of sterile injectable preparations of curares
6 October 2021Zamani N.1, Albaut V.1, Maillard F.1, Delannoy V.1, Soulairol I1, 2.
1 Pharmacie, Centre Hospitalier Universitaire Caremeau, Nîmes France
2 ICGM, Université de Montpellier, CNRS, ENSCM, Montpellier, France
Faced with supply tensions linked to the COVID-19 crisis, the production of curare in batch preparations packaged in polypropylene (PP) syringes was considered. Sterile injectable preparations are tested, among others, to a control of the visible particle contamination using a visual inspection table (VIT). Considering the emergency context, the cost of an industrial VIT, the space constraints and the simplicity of the equipment, the manufacturing of a VIT by our technical team was chosen.
This work consisted in the validation of the VIT, and in the training and accreditation of the operators (OP) for the visual inspection of the syringes produced.
Materials and methods
In accordance with the European Pharmacopeia (EP) (2.9.20), the VIT consists of a matt black panel, a non-glare white panel and a lighting ramp. The EP does not describe any light intensity specifications for plastic containers. Therefore, the recommendations of the Japanese Pharmacopeia (JP) were followed: i.e. between 8000 to 10000 lux (6.06). A luxmeter was used to perform the validation of the VIT. The studied area had 3 vertical planes at a distance of 25, 30 and 35 cm from the light ramp, each including 3 horizontal planes of 5 squares (64 cm2). A defect library was created according to the physical and particulate defects potentially found on the PP syringes of curares.
At 25, 30 and 35 cm the light intensity intervals were [930; 15900], [1490; 10400] and [1840; 8300] lux respectively. On the horizontal plane in the three central squares, the light intensity was between 7900 and 10400 lux at 30 cm; between 7100 and 15900 lux at 25 cm and between 5800 and 8300 lux at 35 cm. For the training library, 11 control syringes were prepared. The accreditation library consisted of 60 syringes, among which 11 (18%) had a defect. Eight OP were trained and evaluated with an average success rate of 87.5%. Unidentified defects were : presence of compress fibers (n=5), presence of solution in the plunger seal (n=4), lack of labeling on the syringe (n=1) and presence of glass particles (n=1).
The optimum viewing area is therefore located in the central zone of the horizontal plane at a distance of 30 cm from the light ramp. The success rate is satisfactory but 62.5 % of the OP did not detect the presence of compress fibers and 50% the presence of solution in the plunger seal. The training thus needs to be focused on these defects. On the other hand, the manufacturing process includes 2 filtrations and an aseptic distribution in syringe in closed system allowing to limit the risk of particulate contamination. So the VIT was validated and was able to meet a need in an emergency situation while respecting the specifications of the Pharmacopeias.