New European resolutions and particle monitoring of high risk hospital preparations : moving towards GMP

J. Martin, MA. Vonesch, F. Soudi, E.H. Diouf, C. Pivot, F. Pirot Pharmacie, Hôpital Édouard Herriot, Lyon

Introduction

In order to provide high risk preparations, our Controlled Atmosphere Area (CAA) needs to be conform to Good Manufacturing practices (GMP) according to the new European resolutions. [1] [2]

Aim

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.

Results

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.

[1Résolution CM/Res(2016)2 sur les bonnes pratiques en matière de reconstitution, dans les établissements de santé, des médicaments destinés à un usage parentéral

[2Résolution 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

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