Isotron offers sterilisation and decontamination services to the laboratory sector to treat products including pharmaceutical raw materials, veterinary product and laboratory disposables.
While 'sterile' is an absolute term, in reality it means a statistically low probability that a unit will be found to be non-sterile after exposure to a sterilisation process.
To qualify for a CE mark, awarded under European Standard EN 556, the threshold is one surviving micro-organism per million products.
Sterility is a critical issue, so when dealing with sterilisation and related issues it is important for manufacturers to work with an experienced, knowledgeable and skilled partner.
Isotron offers three principal sterilisation technologies of gamma, ethylene oxide and electron beam.
It also offers microbiological testing and sterilisation validation studies to assist customers in meeting the requirements of various national and international standards for the manufacture of medical devices and pharmaceuticals.
These include meeting the requirements of ISO 11137 and ISO 11135.
Isotron routinely treats finished products and raw materials to lower or eliminate microbiological contamination.
When bioburden in a product is too high, the product may require reworking or disposal.
Whichever way, this usually results in reduced operational efficiency and a commercial loss.
Isotron said its processing technologies are of particular benefit in ensuring that materials typically with high microbial counts are sanitised prior to being incorporated into the final product or sold.
Isotron processes are regularly used to treat cosmetics and toiletries, pharmaceutical raw materials, veterinary product, laboratory disposables, dyes colorants, packaging, documents, food and horticultural products.
Each of these product types is very different in terms of material composition, suitability to the process and the level of microbial activity present.
Isotron said it has the expertise and variety of treatments to ensure that the appropriate solution is available to meet application requirements.
Laboratory services are an essential addition to the services that Isotron offers to customers.
With its primary markets in medical devices and related industries, there is a necessity to offer these services to answer all of the needs that customers may have.
However, Isotron said it is not just medical device customers that can benefit from its laboratory services; the range of tests, training and consultation available ensures that the company can offer some benefit to almost all of the customers it works with, whatever the industry.
