Fumigation and Sanitization in Secondary Pharmaceutical Facilities

Fumigation is a process used for rooms, safety cabinets or enclosed spaces (e.g. isolators, tents) using gases or finely dispersed sprays. The objective may be decontamination of the room or machinery/equipment within the space or both. Generally fumigation has been used for sterile product or other clean product environments although there are other applications such as animal houses. In the past Formaldehyde was very commonly used but the hazards of the material (toxicity, safety of handling etc) has led to its use now being very restricted.

The modern approach to rooms and large equipment has been the use of surface agents or sprays and management to reduce contamination and the need for fumigation. The commonest use of fumigation is now restricted to small totally closed environments such as isolators where a variety of agents are used. Formaldehyde is used here but is being superseded by more effective agents such as Vapour Phase Hydrogen Peroxide (VHP), although the generators for VHP are still very expensive. In these closed environments it is usual to use a proprietary generator, to generate and circulate the vapour or gas, matched to the isolator. Other agents used include peracetic acid (very aggressive on surfaces) and combinations of Formaldehyde, hydrogen peroxide and peracetic acid. Recently the use of VHP for rooms has been introduced and references to other agents such as Chlorine Dioxide are also available.

Sanitization is a widely used term with a variety of definitions but IT is essentially used to describe a process to reduce, but not necessarily eliminate, microbiological contamination. In its widest sense it may involve uses of sterilizers or irradiation at sub-compendial levels but in the context of cleaning and disinfection may be seen as a process to reduce microbial contamination with chemical agents. This may be a process similar to fumigation (for rooms/close environments) or surface treatment using sprays for equipment, tools or components. The agents used are the same as those for fumigation or disinfection.