The regulations on medical device manufacturers have increased over the last few decades in order to maintain the level of assurance that the product is sterile and fit for purpose. Over that period device manufactures have worked with many technologies in order to sterilize their products.
The major methods used have been steam, ethylene oxide (ETO) or irradiation. While there are other methods these three have been the most widely used.
With the device manufacturer needing to balance production and utilisation the best method has always been affected by the product itself as not all products are suited to all the different methods available. Also the cost of the process has been a big factor in the decision on how to process and achieve sterility of the end product.
Some major manufactures have been at the forefront of technical development and standards of these services and the products that we make at Harwell Dosimeters have played a critical role in the irradiation methods used by most of these companies.
We are pleased to be key suppliers to these organisations and work closely to ensure our products help them achieve their approvals and standards required to release their products to the market place.