New European resolutions and particle monitoring of high risk hospital preparations : moving towards GMP
The aim is to assess the performance of a new portative particle counter (PC) intended to ensure a continuous particle monitoring.
Materials and methods
The 2 PC, (A) and (B), had a flow of air sampling of 50 L/min (A) and 2.8 L/min (B), area of sampling of the isokinetic probes of 15,9 cm² (A) and 1,77 cm² (B). Four tests have been defined in the same CAA C classified (29,7 m3, renewal rate of 39 vol/h, without activity) : #1 five successive measurements of 1 minute, #2 five simultaneous measurements of 1 minute, #3 five alternative measurements of 1 minute and #4 ten alternative measurements of 1 minute.
After analysis according to a Wilcoxon-Mann-Whitney test, no significant difference of the particle monitoring rate with A and B (0.5 and 5 ìm) was found (#1 p= 0,15 and 0,14 ; #2 p = 0,83 and 0,83 ; #3 p = 0,80 and 0,83 and #4 p = 0,96 et 0,46). A significant linear relation has been shown between the particle monitoring obtained with (A) and (B) for the 0.5 ìm diameter particles y = 0,58x + 111 ; R² = 0,901 and for 5 ìm diameter y = 0,45x + 24 ; R² = 0,721.
Discussion and Conclusion
The measurements with the 2 PC have shown no significant difference (p > 0,05), despite the flow sampling difference. Furthermore, the demonstrated linear relation suggests that that the particle monitoring with (B) has a proportional performance to those of (A). The investment of (B) is planned in order to meet the needs of particle monitoring.
 Résolution CM/Res(2016)2 sur les bonnes pratiques en matière de reconstitution, dans les établissements de santé, des médicaments destinés à un usage parentéral
 Résolution CM/Res(2016)1 sur les exigences relatives à l’assurance de qualité et d’innocuité des médicaments préparés en pharmacie pour les besoins particuliers du patient