Supplying pharmaceutical glass vials in hospital pharmacy : A glance over the fence and the new world
The production of sterile pharmaceutical preparations by specialized hospital pharmacy requires miscellaneous sterile, particle free and apyrogenic type I or II glass vials, rubber stoppers and flip-off aluminium crimp (FAC) seals suitable for proper parenteral administration in various clinical situations and for insuring adequate compound stability. The particularism of hospital pharmaceutical production including small batches (< 300 units) and packaging is a fence for supply from manufacturers providing usually large quantities. In the present work, we report a journey over the new (pharmaceutical) world for the quest of ready-to-use pharmaceutical glass vials, and finally the feasibility analysis evaluating the complexity and cost implications for a home-made production of sterile, particle free and apyrogenic type I or II glass vials.
Materials and methods
French, US and Chinese pharmaceutical glass suppliers were solicited to meet hospital pharmaceutical specifications including the supply of 5-mL, 10-mL, 20-mL, 50-mL, 100-mL transparent and yellowed type I/II sterile, particle free and apyrogenic (uncapped) glass vials, rubber stoppers and FAC seals packaged separately in 50-100 unit boxes. Certificate of analysis and release certificate were mandatory with the shipment of samples for analysis. “At the same time”, a feasibility analysis was conducted for evaluating the effectiveness and costs of disinfection, cleaning, depyrogenation (dry heat), sterilization (autoclaving and -irradiation) of pharmaceutical glass vials, rubber stoppers and FAC seals by hospital pharmacy.
Results and discussion
One supplier did not meet pharmaceutical specifications (no certificate of pharmaceutical analysis), one supplier offered 20,000 sterile, particle free and apyrogenic units (5-mL to 100-mL, rubber stopper and FAC seals) for 400 k€ corresponding to one-year production, while one supplier was not able to respond to the request. The providing of unsterilized, no-pyrogen free, uncleaned pharmaceutical glass vials, rubber stoppers and FAC seals from industrial was 9 k€ for one-year production. The feasibility analysis of home-made disinfection-cleaning (in ISO 8 environment) of materials, followed by double-wrapping then depyrogenation (180°C for 3 h)1 in oven, and finally sterilization by autoclaving (121°C for 20 min) or by -irradiation (i.e, rubber stoppers) showed safe and cost-saving approach.
The supply of ready-to-use pharmaceutical glass vials, rubber stoppers and FAC seals in small packages from international industrials is either unfeasible or so expensive that home-made production of sterile and apyrogen pharmaceutical materials from raw supplies constitute the most appropriate method for the (old but advanced) hospital world.
1 AFNOR. Stérilisation des produits de santé - Chaleur sèche - Exigences pour l’élaboration, la validation et le contrôle de routine d’un processus de stérilisation pour dispositifs médicaux. NF EN ISO 20857, Juillet 2013 : indice de classement S98-104. 60 p.