Packaging and Sterilization
Hart’s standard validated packaging and sterilization system is available to make bringing your product to market as easy as possible. Using our packaging and sterilization system is a proven and easy way to design your package. It is designed around needle type devices, and already validated for a wide variety of medical materials, including all of our standard devices.
Studies are on file that establishes SAL (Sterility Assurance Level), Bioburden, Non-pyrogenicity, Non-toxicity, and Package Integrity. Typical sterilization turn around is two weeks.
Eto residuals, and Bacterio-Stasis and Fungistasis, which are highly material dependent, are established for Hart Standard Products, but may require testing for custom devices.
Hart Enterprises maintains a contract relationship with an ISO 9002/EN 460002 sterilizer to provide reliable and verifiable results.
At Hart Enterprises, we make it easy for you to receive your product packaged, sterile, and ready to sell. Just send us your artwork and label copy, or if you desire we can design a label for you.