Water is a universal solvent that has numerous applications. It is also the safest for use in all applications. Our application for sterilization in a giant autoclave to kill bioburden has opened equally numerous opportunities for its application.
HOTTTT STEAM is lethal.
Historically, (It's got a long history since the 1600’s…. History of Instrument Sterilization - Health Beat) steam used in sterilization is pure water that is made really hot… 121°C hot… This allows for a high #lethality of application. The CDC defines #bioburden which is easily eliminated via steam. This achieves the necessary result without any harmful or external chemicals entering the product. SIMPLE!
Release of product post sterilization can take time. Steam allows for multiple release methods.
Published article, Moist Heat Sterilization: Principle, Advantages, Disadvantages (microbeonline.com), talks a lot about Biological indicators - which although used on older processes to release #medicaldevices. Steam allows to move to #ParametricRelease (Parametric release allows manufacturers to replace sterility testing of samples drawn from the. finished product as a release criterion with acceptance criteria for the control of identified. process parameters. FDA Guidance for Sterilization) for medical device per #ISO13485. This in our view is one of the real benefits of Steam - only a few simple parameters to be measured and you have a fast and efficient process.
So does that mean Biological indicators are obsolete? Comment below.
Packaging has to be capable of withstanding moisture temperature… and that's all?
Packaging is a universally required item for all sterilization methods. With minimal requirements on specification of packaging for moist heat sterilization, there are multiple types of options easily available that can withstand the temperature. Packaging can be in the shape of a pouch with a breathable material, foil with a vent header, a tray with a breathable top or vials for liquids. Material that cannot stand high temperatures would not be a good fit for this type of packaging. Integrating a sterility indicator (shows if sterilization has occurred or not) on the packaging is becoming a industry standard. Regardless of the choice of packaging, most are closed systems allowing only the heat or steam to penetrate the packaging.
This is so common, that ISO17665 is been around for a LONG time
ISO 17665, Steam Sterilization, is a simple yet very effective decontamination standard. Sterilization is achieved by exposing products to saturated steam at high temperatures (121°C to 134°C). It lays out the requirements of moist heat sterilization (another name for “steam sterilization”). While there is a science to this sterilization process, there is customization required for each individual product to achieve the desired results. The standard makes it easy to get regulatory approval as well as provides harmonization of process details.
If these are the benefits and water is wet, why does the product not come out wet ?
Steam enters and exits the chamber and is not intended to alter the product. This comes down to how you set the process up and how the product is presented to the sterilizer - think about how you load a dishwasher if you do not place items where they can drain they come out wet, in addition you need a drying step - when done correctly the product will come out dry.
How do we fit into all this?
Advasaf Sterilization provides contract sterilization, laboratory testing, and product and packaging testing services to manufacturers of medical devices, pharmaceuticals, consumer goods, and industrial products.
We support our Customers throughout the sterilization process with a comprehensive offering of testing and validation services, including microbiological, analytical, and product and packaging testing.
ISO 13485:2016 Certified Medical Device Quality Management System certification ensures that your product will benefit overall performance by consistently providing safe and qualitative medical devices and services.