Fumigation Within A Pharmaceutical Aseptic Filling Line

The Challenge:

A pharmaceutical production facility required Bioquell's Room Bio-Decontamination Service (RBDS) to remove  Staphylococcus epidermidis contamination of an aseptic filling suite (c.1000m³). The target area consisted of an aseptic zone (c.300m³) and a clean zone (c.700m³) with areas ranging from European GMP Grade A to Grade D. The key criteria used to select the method employed were: (i) proven efficacy against S. epidermidis; (ii) ability to
meet FDA regulatory requirements; (iii) in situ fumigation of intricate filling, capping, washing and freeze-drying machinery; (iv) residue-free technology to ensure that no toxic residues contaminated the product; (v) minimization of lost production time; and (vi) documented verification of the biological efficacy of the process.

The Solution:

Bioquell's RBDS, as the only solution to fulfill all the above criteria, was selected to treat the area. The aseptic and clean zones were fumigated sequentially. Six Clarus 'R' Hydrogen Peroxide Vapor (HPV) generators were strategically placed in the zones to ensure even vapor distribution, eight Clarus R2 aeration units were also
included to remove the HPV at the end of the cycle and an instrumentation module was located in each zone to monitor the key parameters in real time.

Each zone was then sealed before fumigation commenced and remained sealed until the HPV had been removed at the end of the process via catalytic conversion to water vapour and oxygen (the air-handling unit (AHU) within the building was also used to accelerate the aeration process). The entire process was monitored and controlled from outside the room via the control computer and the perimeter of each zone was monitored for leakage using hand-held HPV sensors.