Until I joined Ecolab I had absolutely no idea that there was a link between Harry Potter, Tinker Bell,Gandalf and some pharmaceutical manufacturers. What is the link? Magic of course.
Where and why are pharmaceutical companies utilising the dark arts (and I am not talking about Microbiology – I can hear all of you Chemists out there…). It is in the science of transfer disinfection. I have seen a number of truly eye‐opening practises in the industry that lead me to conclude that in the absence of anything resembling a structured approach to transfer disinfection, the company must be relying on hope or magic. The magic I am talking about is a powerful one, it allows dirty items from external environments to be brought into cleanrooms with no transfer disinfection. Any contamination that is present on the items, whether microbial, chemical, or physical are apparently prevented from leaving the transfer area by magic alone.
Here are three examples I have witnessed in the last 12 months.
Ecolab does not have a school of magic education, so I can only comment on best practice for mortals.
The most commonly used disinfectant for transfer disinfection is traditionally alcohol. It is a great choice, as it if fast acting, has a broad spectrum of activity against vegetative cells and leaves little or no chemical residue behind. It comes in a myriad of formats from reputable suppliers to fulfil the needs of most aspects of transfer disinfection. Its one major drawback? It is not sporicidal. Spore forming bacteria and mould spores normally come under the general heading of ‘environmental isolates’ when they are recovered from a cleanroom. These organisms are naturally present in the outside world and can be found in particularly high numbers in soil, wood, and man‐ made materials such as cardboard.
One route of ingress for these types of microorganisms into a cleanroom is by their presence in high numbers on these ‘high risk’ materials such as wooden pallets and cardboard boxes. Then subsequently ‘hitching a lift’ on consumables that have been in contact with these materials that are then destined for cleanroom areas. For this reason, elimination of wood or cardboard, ‘de‐trashing’ or removal of outer wrapping is required at appropriate points. As is the need for a sporicidal disinfectant at some point in your transfer process from the warehouse to product contact areas, preferably at the beginning of the process, where the bioburden level is likely to be higher. The requirement to consider sporicides for transfer disinfection rather than alcohol alone is not a new one.
The PIC/S Recommendation on the Validation of Aseptic Processes PI 007‐6 January 2011 states:
“Sporicidal agentsshould be used wherever possible but particularly for “spraying‐in” components and equipment in aseptic areas.”
The MHRA Guidance for Specials Manufacturers 2015 states:
“Before transfer to the manufacturing room, a sanitisation step using a spray and wipe technique including a sporicidal agent designed to inactivate bacterial and fungal spores must be carried out.”
FDA Aseptic Processing Guide states:
“It is critical to adequately control material (e.g., in‐process supplies, equipment, utensils) as it transfers from lesser to higher classified clean areas to prevent the influx of contaminants. For example, written procedures should address how materials are to be introduced into the aseptic processing room to ensure that room conditions remain uncompromised. In this regard, materials should be disinfected according to appropriate procedures…”
Annex 1 Feb 2020 v.12 DRAFT REVISION 4.12 ii states:
Heavily soiled outer wrappers should be removed first and discarded. The same applies for dirty pallets. ‘Captive’ pallets (pallets manufactured from a more suitable material such as metal or plastic, that are subject to regular documented cleaning and disinfection, and that remain, or are ‘captive’ in a specific cleanroom grade) can be useful. Items to be disinfected as part of material transfer should be wiped with the disinfectant as mechanical action greatly increases the efficacy of a disinfection process and allows greater contact of the disinfectant with the microbes. The mechanical action of the wipe will also remove some of those organisms that the disinfectant cannot kill, such as endospores.
So, if you work in a Life Sciences site, you cannot find Tinkerbell, Harry Potter is back at school and Gandalf is in the Bahamas, consider the following: