Onsite vs Contract Sterilization
Not necessarily. The decision on whether to go with contract sterilization or an in-house system is based on several factors which include, along with product volume, what types of sterilization methods your product can handle, how fast you need it sterilized, and how much control you want over your product.
The purpose of sterilization is to inactivate any and all microorganisms on or in the product without rendering the product ineffective in the process. An autoclave is simple and relatively inexpensive to install in-house, but many products simply cannot take the heat involved in steam sterilization.
Ethylene oxide is a widely used sterilant that has a high penetrating power effective for sterilizing a wide variety of instruments and devices in their final packaging. There are only a few reasons why a company would choose not to go with EO sterilization, including product incompatibility and again, heat sensitivity, but the biggest reason many people are moving away from it is that EO is a known carcinogen. The risk can be nearly eliminated with proper aeration after sterilization, but this results in slow turnaround times.
Irradiation, using either gamma or electron-beam technology, is a widely-used alternative to EO sterilization, allowing greater versatility in packaging, since these methods aren’t limited to materials that can be penetrated by gases. However, these techniques tend to degrade some materials, resulting in reduced shelf life and/or discolored product. The other advantage lies in turnaround time which can sometimes be a matter of merely hours, as opposed to the several days that EO can take.
EO and irradiation facilities that will accommodate most companies’ needs are very costly to build and require numerous safety features because of the hazardous nature of both processes. So it is usually most cost-effective to use a contract sterilization company for these types of sterilization methods unless you have a very large product volume, or the nearest contract facility is so far away that transportation costs become prohibitive. Contract facilities also have the advantage of trained sterilization experts who can not only provide quality assurance on sterilization, but also know how to validate products to meet FDA requirements.
But what if the product is sensitive to both EO and irradiation? Or what if you want an in-house system to provide lightning-quick turnaround times so that you need not maintain a large inventory of product waiting to be sterilized? There are a few other methods of sterilization, which either were designed for or can easily be adapted to small volumes, use technology that succeeds where other methods fail, and leave little or no harmful residuals on the product.
That said, how does your company go about deciding which sterilization method will best fit their needs? What other factors do you consider? Let us know in the comments! To see a checklist and flowchart designed to help companies through the decision process, take a look at our newsletter.