Survey of microbiological sampling practices in anticancer drugs preparation equipement
For the reconstitution of anticancer drug, it is critically important to monitor microbiological (MB) environment of equipment.
Good manufacturing practices provide recommendations on the limits of MB contamination without notions of sampling frequencies. We decided to focus on the practices of MB controls from different centers.
A survey of different centers practices through an online questionnaire was developed from the litterature. It consists of 61 questions shared on 4 parts: general (equipments, cleanroom clothing, handling techniques), disinfection and cleaning of equipment, MB environmental monitoring. Participants could respond from March 27th to June 27th, 2017. Some centers got the survey by mail while others got it directly from a network professional association site.
44 french centers and 1 swiss center answered. Equipments of the different centers are allocated in : 34 with isolators, 8 with laminar flow hood, 3 with "cytobox" and one center with an automatic robotic.
All the centers carry out an environmental MB control (surfaces and / or air). 7 centers do not monitor air microbiological contamination of their equipment. Methods of cleaning and disinfection are heterogeneous. In 17 cases, the MB control samples are realised, at rest, at heterogeneous frequencies. Only 16 centers realise gloved fingertip prints sampling.
This survey shows heterogeneous practices between centers explained by an absence of recommendation but an obligation of control. MB environmental monitoring not only ensures quality assurance of production but also quality control of work.