Vaporised peracetic acid has been found to be a safer and more productive alternative to commonly used ethylene oxide in the production process for Medical Device Manufacturers as a device steriliser.
Ensuring that the chances of infection are eliminated through proper sterilisation is the highest priority for producers of medical devices, such as implantables, in order to comply with the FDA but also more critically to ensure patient safety. For many companies operating in this industry niche, ethylene oxide is one of the most common chemicals used to perform this role.
However, there are a number of significant drawbacks for manufacturers of medical devices of continuing to use ethylene oxide including:
- Larger Investment – Companies using ethylene oxide to sterilise products must have facilities that comply with safety regulations which in most cases requires large investment.
- Large Batch Production – As a result of the investment needed for facilities, medical device manufacturers outsource EO sterilisation of their products. However, to make outsourcing a more logical option, these companies must produce larger batches which means increasing time spent in production and ultimately time to market.
- Transport/Logistics – By outsourcing, these companies must also have or source transport capabilities to move the devices which adds an added cost and inefficiency in the production process.
- Heat – Ethylene oxide sterilisation has to be undertaken at a high temperature of 40 °C which means that it can have a negative impact on heat sensitive product materials.
- Chemical Residue – The most critical drawback of the use of ethylene oxide for device sterilisation is the process results in carcinogenic chemical fumes. These leave residues that create significant safety concerns for hospitals as they do not want known carcinogens on their premises.
Due to the creation of dangerous fumes, the devices require a period of aeration that only serves to increase the time to market and delay shipments creating further production ineffiencies.
On the other hand, peracetic acid has many advantages that can lead to improvements of both safety and speed in the production process efficiency. PAA vapor sterilisation can be undertaken at room temperature meaning that it can be used on a larger scope of materials the ethylene oxide.
Furthermore, the by-products of peracetic acid of carbon dioxide, water and oxygen are all natural and non-harmful meaning that sterilisation can be undertaken on-site and there is no aeration time requirement which rapidly increases the product turnaround and removes the requirement for 3rd party sterilisation reducing costs.
About Airedale Chemical
Airedale Chemical are one of the UK’s fastest growing chemical manufacturers. We specialise in the production of specialist chemicals including peracetic acid.