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

14 October 2019

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: except for

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.

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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