Sunday, 25 October 2020

Zherox® b-pack - new portable biodecontamination system

 

Zherox® b-pack is the new portable biodecontamination system by AM Instruments, indicated explicitly for preventing contamination in pharmaceutical contamination controlled areas.

In “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing” – June 2020, FDA offers guidance describing the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.

The document focuses on manufacturing controls to prevent contamination of drugs. To help prevent transmission among employees and contamination of drugs/materials by a COVID-19-infected employee engaged in drug manufacturing at the workplace, drug manufacturers should:

• Clean and sanitise non-production areas (such as offices, elevators, break rooms, changing rooms, and restrooms) more frequently

•Update existing procedures to institute more frequent cleaning, sanitisation, and/or sterilisation of surfaces in the production areas, mainly surfaces that are contacted frequently, such as door handles, equipment latches, bench/countertops, and control panels. Particular attention should be paid to sanitising/sterilising 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 guidance 18 and standard practice, to limit the possibility of contamination.

If a potential or actual viral contamination event is identified, drug manufacturers should promptly clean, disinfect, sanitise, and if necessary, sterilise affected equipment, surfaces, production areas, and facilities, before resuming manufacturing.


Zherox® b-pack represents the ultimate solution for efficacy, rapidity, compatibility, safeness and quality. The state-of-the-art technology based on a powerful electromagnetic field creates micro-droplets that will reach even the most challenging areas, ensuring complete coverage of all surfaces.

Innovative Zherox® technology applied to a lightweight, portable system, allows maximum ease of operation in total safety for the operator and with proven effectiveness. Zherox b-pack is a battery-powered portable device with ergonomic shoulder straps and back. The backpack contains the tank of Pharmaclean Solution, a blend based on hydrogen peroxide, which ensures maximum compatibility with all type of materials.

The control electronics permit optimum battery management. The status LED on the diffuser indicates the charge level and the operating phase.

The aluminium alloy frame and the ABS body make the unit lightweight and ideal for frequent use. The ergonomic TLP diffuser permits continuous use avoiding operator fatigue. 


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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