Methods for visual inspection of preparations for parenteral use: between investment, reliability and training in hospital pharmacy

5 October 2023

M. Forat1, A. Jambon1, S. Filali2, C. Morel2, C. Merienne1, C. Marchand2, F. Pirot1,2,3
1 Plateforme Fripharm, Service Pharmaceutique, Groupe Hospitalier Centre Edouard Herriot, Hospices Civils de Lyon, 5, Place d′Arsonval, F-69437 Lyon cedex 03, France
2 Service Biomédical, Groupe Hospitalier Centre Edouard Herriot, Hospices Civils de Lyon, 5, Place d′Arsonval, F-69437 Lyon cedex 03, France
3 Laboratoire de Pharmacie Galénique Industrielle, UMR 5305, ISPB-Faculté de Pharmacie, Université Claude Bernard Lyon 1, 8, avenue Rockefeller, F-69373 Lyon cedex 08, France

The COVID-19 pandemic had unsuspected and original manifestations, illustrated by the management of the drug shortage through the development of hospital production of sterile pharmaceutical preparations (P2S). Visual inspection of P2S is a liberatory control whose methods are described in the monographs of the European Pharmacopoeia (2.9.20) and the American Pharmacopoeia (1790). However, these non-automated visual methods require staff training and aptitude testing. The main objective of this study was to compare the reliability and analysis speed of two visual methods and an automated method for detecting visible particles by image analysis in P2S. In addition, these methods were used to assess the sources of particulate contamination during pre-production (washing, desinfection, depyrogenation) and production (filling, capping) processes.

Materials and Methods
By manual (IVM), semi-automatic (IVSA) and automatic (IVA) visual inspection, three pharmacy technicians examined 41 glass vials (type I, 10 and/or 50 mL) as follows: (i) 16 vials filled of water for injection (WFI) containing glass particles (224 µm or 600 µm), or fragments of stopper, or textile fibers; (ii) 5 conventional sterile injectable specialties; (iii) 20 vials filled by WFI throughout different pre-environments.

Results and Discussion
IVM and IVSA detected 100% visible particles, compared with 28% for IVA, which failed to detect textile fibers. All three methods correctly analyzed P2S exempt of visible particles. All three methods detected particles in vials maintained under ISO 9 pre-production conditions. On the other hand, detection by (i) IVM and IVSA and (ii) IVA of particles contained in flasks maintained under ISO 8 pre-production conditions were judged satisfactory and unsatisfactory respectively.

The importance of visual inspection of P2S requires fast, sensitive and reliable detection methods. In this context, IVM and IVSA have proved more effective than IVA, at a more competitive cost in terms of investment, training and implementation.

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