As companies look for better premises, cheaper energy and more productive workforces globally there is an increasing need to decontaminate buildings and facilities used for the production of penicillin. During the production of Penicillin and other antibiotics the fabric, equipment and extract systems within the building become contaminated with beta-lactams which need to be decontaminated prior to re-occupation.
The first step in the process is to undertake an assessment of the level and location of contamination. This involves looking at the three core areas within the building which are:-
o The fabric of the building – The extent of contamination to walls, floors, ceilings, from pharmaceutical dusts / powders.
o The equipment – Any equipment used within the building
o The extract systems – All of the extract systems such as HVAC systems, Dust Handling Systems, Local Vacuum Exhaust Systems
The assessment should determine and report on the level of contamination in each location of the building.
Determine the End Point
There is no defined global standard for the level of cleanliness following decontamination but there are a number of studies that are used to identify a reasonable clean-up standard. Achieving nil contamination is both impractical and meaningless as there are natural levels of beta-lactams present in many commonly used products such as milk. The building owner needs to derive a measurable decontamination level that they are happy to be applied. Many pharmaceutical companies have their own corporate policy / guidance on an appropriate measurable standard.
There are a number of different decontamination methods available depending on the level of cleanliness you require, the level of contamination and the location and the available budget. Some of these are as follows:-
o Removal – removal of beta-lactam source areas e.g. ductwork containing powders is the best option for the best level of clean but is often cost –prohibitive
o Dry Vacuum and Mist / Fog Treated – Where removal of areas where dust and residues still remain the remaining option is to Dry Vacuum to remove all of the dust / debris and then use an anti-bacterial sterilisation treatment by misting or fogging.
o Wet Wash – The building fabric, etc can be decontaminated using a wet wash with an anti-bacterial detergent and / or a sodium hypochlorite application and rinse. This application will not work on all surfaces, especially absorbent building fabrics where the application of water-based decontamination solutions will damage the fabric surfaces.
o Gassing Techniques – Application of Ozone or Chlorine Dioxide can be applied to specific rooms and items of equipment but requires a detailed assessment prior to proceeding.
Validation and Verification
A verification and validation procedure would need to be prepared and implemented as part of the decontamination process. Clearly, if the procedures to decontaminate and then measure and record the decontamination are not auditable, and traceable, then they are not defendable.
Assay is usually by HPLC or agar-plate analysis of selected swab samples taken via a prescriptive sampling regime. It is usually better for at least the verification analysis to be undertaken independently to give added credibility to the results. Taking the samples can be undertaken by a competent body. The recording of the data is best done by a body familiar with quality systems (ideally GMP) so that it may be recorded in a pharmaceutical format.
The confirmation of decontamination is based upon the validation and verification of the results of the swab sampling.
The process of decontamination of a building contaminated with penicillin is often a long and complex process so careful planning is required and a good working knowledge of the available decontamination methods and their positives and negatives.