Formaldehyde was long considered the undisputed fumigation champion for ridding your cleanroom (and all other aseptic spaces) of any and all contaminants. Then, in January 2016, EU legislation reclassified formaldehyde as a class 1B carcinogen and class 2 mutagen, placing the widespread use of this popular chemical under scrutiny.
Formaldehyde is low-cost and fast-acting, meaning many current users might still be reluctant to give up using this chemical. Yet, with more stringent regulations for use, Maximum Exposure Levels (MEL) and disposal on the horizon, it is time for any facility clinging on to this nasty chemical to move away from it for good.
Here are 10 reasons why you should remove formaldehyde from your cleanroom decontamination process
1. Formaldehyde is quickly becoming an unviable cleanroom decontaminant
Formaldehyde is registered as a biocide throughout Europe, as per article 95 of the Biocide Products Regulations. It is costly for manufacturers to register this chemical and with fewer companies making use of formaldehyde in their facility it may simply become obsolete for cleanroom decontamination as it is no longer cost-effective to produce it.
2. Formaldehyde is a known human carcinogen and mutagen
Since January 1st, 2016, formaldehyde has been reclassified as a category 1B carcinogen with a CLP concentration and as a category 2 mutagen, which restricts it from being supplied to the general public. Do you really want to be working in an environment where this toxic chemical is regularly used?
3. Formaldehyde can cause all sorts of health and business problems
The consequences resulting from too much exposure to formaldehyde are serious. It is corrosive, so can cause damage to machinery and equipment. People who come into contact with it can experience everything from skin irritation to breathing problems. This could lead to costly staff absences and effect your productivity. It could even have legal implications if it is proved MEL has been breached.
4. Under the EU’s REACH (Regulation, Evaluation, Authorisation and restriction of Chemicals) regulation, formaldehyde could become subject to further limitations
This ruling will call for stricter regulations regarding the disposal of formaldehyde. Unsurprisingly, this chemical can have a very negative effect on local environment and procedures for its safe disposal are likely to become increasingly stringent.
5. Formaldehyde is a quick fix that can cause long-term problems
Formaldehyde has retained its status as popular cleanroom decontaminant because its kills pretty much all microorganisms and it has always been cheap to buy. However, it tends to be absorbed into filters and other substances. This means if the ventilation is switched off after fumigation, levels of the chemical can build up in the room.
6. Long contact times
While formaldehyde is an easily available solution, it is not one of the fastest acting. This chemical requires a contact time of between six to 12 hours before it actively and effectively decontaminates an area.
7. It leaves a mess behind that requires another unpleasant chemical to remove
The process of using formaldehyde as a decontaminant leaves a residue such as paraformaldehyde (also a carcinogen) or methenamine (used in antibiotics) behind. Neutralising formaldehyde requires the use of ammonia gas – another rather unpleasant chemical that can cause serious respiratory distress in humans.
8. The thorough cleanup post cleanroom decontamination is labour-intensive
Post formaldehyde decontamination cleanup is time consuming and you will need a dedicated team who have the knowledge to ensure your space reverts to a completely aseptic environment. This team must make sure to clean the hard-to-reach places too such as your HEPA filters.
9. Cleaning up after using formaldehyde does nothing for your productivity
Acceptable levels of formaldehyde air contamination in the workplace under EU regulations are 2 parts per million. Achieving and maintaining this extremely low Maximum Exposure Level (MEL) requires lengthy periods of downtime between decontaminations. If your competitors have already switched to a more manageable decontaminant with less post-decontamination time required, they will benefit from higher productivity levels.
10. Formaldehyde is extremely sensitive to humidity and produces variable kill levels
The sporicidal activity of formaldehyde gas varies with its concentration, relative humidity, degree of microbial cleanliness and the surface holding the organism. These variables make it very difficult to assign precise exposure times for large-scale formaldehyde decontamination.
The formaldehyde-free future of cleanroom decontamination
Whatever you are considering as your formaldehyde alternative: chlorine dioxide, vaporised hydrogen peroxide, peracetic acid formulations or ozone decontamination, it is also important to plan your transition carefully.
Facility managers and cleanroom operators should investigate how formaldehyde residues might react with the new alternative decontaminant. They must also ensure the replacement method can penetrate an organic spillage in an effort to kill off bio-contaminants. Additionally, before use, the disinfectant chemical and the decontamination strategy used must be validated by the operator responsible for overseeing the operation.
There are many highly effective systems available, with dry fogging proving one of the most popular. A dry fogging solution such as the Minncare Dry Fog System creates tiny droplets of disinfectant distributed throughout the cleanroom. It makes use of a cold sterilant solution consisting of peracetic acid and H202. The delivery system ensures that the decontaminant is diffused throughout the area and rapidly accesses and penetrates hard-to-reach places.
You should also consider your current environmental monitoring solutions and how they could be improved to support and maintain the validation of your new decontamination strategy.
If you would like to investigate better ways to keep your cleanroom effectively free from contamination download our eBook The Pharmaceutical Lab’s Pocket Guide to Cleanroom Decontamination .