Improving flows to limit particulate contaminants in sterile preparation areas

Context and objectives
In our unit, sterile preparations (e.g. parenteral nutrition bags) are performed in class C installations within class A1 equipment (HFLAH). Microbiological samples (agar plates) taken during the process have revealed the presence of contaminants of environmental origin (e.g. bacillus sp). The objective of this work is to improve the material flow necessary for sterile preparations by setting up just-in-time consumable carts.

Materials and methods
1. Analyze the current storage of consumables in the different areas (class C and D): raw materials (RM),
sterile medical devices (SMD).
2. Observe the material and operator flow in the laboratories (spaghetti diagram)
3. Optimize storage: rationalise and set up replenishment trolleys.
4. Evaluate the impacts (flows, contaminats)

Results
1. Storage: PM were mainly stored in class C laboratories (> 2,000 units) with immobilized stock (> 4 months depending on the references), SMD and other consumables were dispatched between laboratories (> 5,000 units) and local storage (C/D).
2. Observation of the flows in the laboratory showed crossings of operators aids, scattered movements in its environment and no use of the nearby RM stock during production.
3. Optimisation:
* Consumables were moved from the Class C laboratories to nearby storage (C/D). A reserve stock of consumables (e.g. swabs) is maintained in the laboratories. A 90% reduction in SMD stocks has been achieved.
* Daily replenishment trolleys containing the consumables needed for scheduled production have been deployed, stock lists have been established and local storage has been organised by an "intelligent" picking system
4. Impact: reduction of the operator movements limited to the replenishment trolleys, no increase in the number of room exits by operators. Growth of sedimentation agar and operators’ hands agar is reduced by 20% (all samples combined).

Discussion – Conclusion
Contaminants (particulate and microbiological) must be controlled to protect the finished product. USP2 and PIC/S3 recommend a minimum of stocks, to avoid contamination and to facilitate cleaning and disinfection. This work has led to a reduction in nearby stocks and improved microbiological sampling. The involvement of the operators is a key factor in the success of this project. It is part of a global approach to controlling contaminants in our unit and will continue with the evaluation of practices under iso 5 (opening of SMDs, introduction and disinfection of RM).

Bibliography
1- Good preparation practices – Afssaps – 03/12/2007
2- « Pharmaceutical Compounding—Sterile Preparations » - United states pharmacopeia chapter 797 - 01/09/2021
3- « Guide to good practices for the preparation of medicinal products in healthcare establishments » - PIC/S – 01/03/2014

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