Medical devices and dressings must be sterilised in order to meet strict regulatory and safety requirements. Different types of sterilisation are essential for killing different strains of bacteria.
BDK is a medical device and wound dressing manufacturer that provide packaging and sterilisation as services within their project management offering. This guarantees delivery of a sterile product to the market, so you can rely on us for your healthcare solutions.
What Are The Different Types of Sterilisation?
By using controlled exposure of a gamma, the high-energy photons penetrate through packaging to effectively sterilise products. This is a safe and reliable method of sterilisation and BDK are certified for management of gamma irradiation sterilisation services.
E-beam sterilisation, also known as electron beam irradiation, uses an electron beam accelerator to ionize product materials which consequently immobilises harmful bacteria. This method is quick and economical when it comes to lower exposure times.
By heating a chamber up to 120°C, humidity and steam become a by-product which kills bacteria. Although this can be used for the majority of materials and products, it is an aggressive method of sterilisation, so there is risk of breakdown or residual moisture.
Ethylene Oxide (EO) Sterilisation
Ethylene oxide is a low level gas alkaline that is used to sterilise certain types of materials that cannot withstand high heat. Although it is flammable, it effective kills bacteria and spores safely from products made of silicone, plastic, metal and glass.
Certain types of sterilisations only work with certain types of materials and products, and this is where BDK come in to help.
How BDK Helps with Sterilisation
BDK is not a sterilisation house, however as part of our ISO 13485 accreditation we are able to control and manage the sterilisation of your product. As part of our end-to-end project management, we deliver accurate validation methods and competent packaging of sterile medical devices in a cleanroom environment.
Each individual product has its own dosage level of sterilisation which is dependent on the materials used to manufacture the product. BDK will work with the sterilisation facility to ensure accurate dose mapping for the product.
Working with BDK, we will manage the precise validation process and ensure it is followed with the sterilisation facility. Testing will be carried out and the sterile product will be produced. This usually includes calculating the dose maximums and minimums, validating the range of these figures and collecting all the necessary data for testing and sterilising.
We are here to help take your product from conception and manufacture through to fully sterilised and to market. Providing hassle-free turnkey solutions, BDK are the number one choice for medical device and dressing product development.
Contact us today to discuss your next project.