Environmental microbiological surface non-conformities in clean areas : 2019 retrospective analysis

Romane GUILLOTEL1, Camille MERIENNE1, Sophie HYVERT1, Anthony MARTELIN1, Samira FILALI1, , Christine PIVOT1, Fabrice PIROT1 1 : Unité de Préparation et de Contrôle des Médicaments, Plateforme de Fabrication Recherche et Innovation Pharmaceutique, FRIPHARM, Groupement Hospitalier Centre - Hospices Civils de Lyon, Pavillon X, Place d´Arsonval, 69437 Lyon cedex 03, France

Introduction
Within the drug production unit of the hospital’s pharmacy, sterile pharmaceutical preparations are produced in controlled environment. Monitoring micro-organisms ensures the absence of biocontamination. The objective of this study is to analyze microbiological non-conformities that occurred on the Sterile Production Area (SPA) in 2019.

Materials and Methods
All results of the 2019 environmental controls in SPA were collected. These data were collected: date, cleanroom concerned, number of compliant and non-compliant samples, surface area and microorganism involved and number of colony units. The proportion of non-compliant results in each room and in each surface type was analyzed to describe areas most frequently involved. The evolution of the number of these non-conformities over the year was also assessed.

Results
In 2019, 90 cleanrooms in SPA were controlled and 1264 control samples were taken. In external corridors, decontamination area (grade D), storage area (grade C) and internal corridor (grade C, B), the compliance rate varied from 94 to 100 %. However, the personal entrance and exit area (grade D, C) were more frequently contaminated: 8 non-conformities out of 77, or 10.4% (87.5% floor). In the PSA, production rooms (grade B, A) were contaminated under 0.5% (4/979 non conformities): 1/168 non-compliant sample in the innovative therapy drugs room (bench), 2/252 non conformities in microbiological lab (handle, workbenches), no contamination out of 196 samples in the vial preparation room or in sterilization and crimping room (0/48), the syringe production room (isolator) was non-compliant only once out of 315 samples (outside of isolator’s glove). Regrouping the non-conformities by month doesn’t show a gradual deterioration over the year. The germs most often found were non-pathogenic polymicrobial flora at 39%, Staphylococcus non aureus at 33% (cutaneous flore), Micrococcus spp. at 11%, sterile mycelium at 11% and Alternaria sp. at 6% (environment).

Discussion Conclusion
Biocontaminations generate a significant human risk with the administration of pharmaceutical preparations to patients. Retraining agents about appropriate hygienic practices in controlled environment (hand hygiene, dressing, etc.) would reduce this residual biocontamination rate, especially on human and environmental germs. Increasing the biocleaning and monitoring frequency in rooms mostly contaminated would be necessary. In 2019, low biocontamination in PSA provided the production unit of the pharmacy to ensure and secure the production of sterile preparations.

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