Sterilization
Key properties of medical devices and drug delivery systems can be compromised if they are not designed to withstand appropriate sterilization methods. Chempilots offers formulation and development of polymeric systems that maintain their functional performance after sterilization cycles.
Specific sterilization challenges
We have experience with the following product-sterilization techniques:
- Steam autoclaving of soft contact lenses in vials (CE mark obtained) and hydrogel implants filled in syringes
- Irradiation sterilization of implantable biosensors and dental implants
- Gas sterilization of vascular and urology devices with hydrophilic coatings
- In-line electron beaming of skin adhesives and wound care products to obtain cross-linking at sterilization dose
Our facilities include our own Matachana steam autoclave. We also regularly collaborate with external service providers, who offer ETO gassing, electron beaming, and gamma irradiation as sterilization methods.
Other non-sterilization methods include aseptic processing in LAF units, UV-light treatment in aqueous systems, and the use of aseptic detergents.
Studies offered
During product design we can conduct the material studies that are essential for proper formulation and product design. We can also contribute to sterilization validation. Examples of studies conducted in relation to sterilization processes include:
- Hydrolysis and rheological change in hydrogel formulations
- Syneresis, including leaking of active pharmaceutical ingredients (API)
- Change in API potency and material compatibility
- Cracking and migration of plastic softener
- Cross-linking of polymers
Contact us
For more information please call Richard Schmidt
on +45 4495 1661 or send us an e-mail.
