Benefit of operational quality in hospital preparation production performance within a new technical platform

Bourtal Imane[1], Martelin Anthony[1], Marilly Elisa[1], Lafont Malo[1], Fulco Baptiste[1], Filali Samira[1][2], Salmon Damien[1][2], Merienne Camille[1], Pivot Christine[1], Pirot Fabrice[1][2]
[1] Pharmacy, Edouard-Herriot Hospital, Lyon, France.
[2] Laboratory of Industrial Galenic Pharmacy, ISPB, Lyon, France.
[*] Coordinates: firstname.lastname@chu-lyon.fr except for damien.salmon01@chu-lyon.fr

Introduction
In a context of resumption of sterile hospital preparations activities, various manufacturing processes were re-analyzed taking into account the organization of new premises and equipment. In addition to a complete restructuring of the quality system for ISO 9001 certification, operational quality management has been applied to control manufacturing processes by eradicating the causes of malfunctions (errors or non-conformities). The aim of this summary is to report a concrete example of the application of an optimization of the manufacturing process of a sterile hospital preparation initially packaged in 1000 mL flasks.

Materials and methods
In bonds of rapid recovery of activity, the use of short-time tools has been favored: (i) problem-solving methods showing concrete nonconformities (in this case the generation of particles and filaments detected (performance indicator) including the cause-effect diagram, brainstorming, QQOQCP method and comparative tests, and (ii) the AMDEC method for analyzing risks at all stages of the manufacturing process.

Results
The investigation showed that process of preparing a sterile solution in glass vials is long and complex. This preparation involved many risk steps for particulate contamination; i.e., washing-disinfection, depyrogenation, double-pack and autoclave sterilization step. In addition, the 1000 mL flasks very bulky did not allow an optimal organization in the production room and required the presence of at least 3 pharmacy technicians. The replacement of the vials with sterile bags appeared to be a good alternative to reduce this risk. The use of the bags in place of the vials, in a closed system, considerably limited the particulate contamination (yield candling bags 100% vs. vials 43%). This new manufacturing process, simplified and mastered by the pharmacy technician, presented economic advantages (pocket € 3.44 vs. vials € 6.23), production delays (bag 3h vs. bottle 18h) and human resources (2 pharmacy technician). Nevertheless, the autoclave terminal sterilization is not possible. So, a sterilizing filtration has been used.

Discussion & Conclusion
Quality, production times and costs, and more generally, production performance depend on the level of operational quality which has been put in place. A stability study is currently underway to determine the expiry date (according to 3 months) in order to optimize the manufacture management. In addition, a new range of autoclavable polypropylene bags (awaiting CE marking) will be used soon.

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