FDA Reccomendations | Zherox® b-pack

In the document: “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing” (June 2020), FDA offers guidance to address the risks of Covid-19 in pharmaceutical manufacturing.

The document focuses on activities aimed at preventing both the transmission of the Covid-19 virus among employees and the contamination of drugs and materials by a virus-positive employee.

Drug companies should:

  • Clean and sanitize nonproduction areas (such as offices, elevators, break rooms, changing rooms, and restrooms) more frequently.
  • Update existing procedures to institute more frequent cleaning, sanitization, and / or sterilization of surfaces in the production areas, particularly surfaces that are contacted frequently, such as door handles, equipment latches, bench / counter tops, and control panels. Special attention should be paid to sanitizing / sterilizing equipment and product-contact surfaces.
  • Consider expanding existing procedures to include using gloves, face masks, and / or gowning where such measures were not previously required.
  • Consider further restrictions on employee access to any manufacturing area, beyond that required by CGMP regulations and recommended by Agency guidance18 and normal practice, to limit the possibility of contamination.
  • If a potential or actual viral contamination event is identified, drug manufacturers should promptly clean, disinfect, sanitize, and if necessary, sterilize affected equipment, surfaces, production areas, and facilities, before resuming manufacturing.

The Zherox® b-pack system is the ultimate solution for FDA recommended biodecontamination activities.

Zherox® b-pack is in fact ideal for more frequent sanitising of non-productive areas such as offices, changing rooms, warehouses etc., with particular attention to surfaces such as door handles, worktops, control panels.

The lightness of the instrument and its autonomy make the biodecontamination cycle as agile as ever; the micro drops of ionised hydrogen peroxide are able to reach even the most difficult to reach areas, with optimal material compatibility.