Claims for Patent: 5,786,598

Summary for Patent: 5,786,598

Title:	Sterilization of packages and their contents using high-intensity, short-duration pulses of incoherent, polychromatic light in a broad spectrum
Abstract:	An approach for sterilizing product containers and deactivating microorganisms in such containers employs the container, which, in one embodiment, includes a polyolefin, and which transmits light in a spectrum of from between 180 nm and 300 nm. The container may be coupled to a port through which a product within the container can be withdrawn, or, alternatively, may include a blister that together with a backing material forms a cavity in which a contact lens is contained. A flashlamp system generates high-intensity, short-duration pulses of polychromatic light in a broad spectrum. The pulses of light generated by the flashlamp illuminate the container and thereby deactivate microorganisms within the container. In some embodiments, the container contains a transmissive product that transmits more than about one percent of light at a wavelength of 260 nm. In further embodiments, the high-intensity, short-duration pulses of polychromatic light in a broad spectrum deactivate microorganisms both within the container and within the port. In additional embodiments, the flashlamp advantageously deactivates sufficient microorganisms to achieve a sterility assurance level of at least 10.sup.-6.
Inventor(s):	Clark; Reginald Wayne (Del Mar, CA), Lierman; James C. (San Diego, CA), Lander; Donald (La Jolla, CA), Dunn; Joseph E. (Vista, CA)
Assignee:	PurePulse Technologies, Inc. (San Diego, CA)
Application Number:	08/651,275
Patent Claims:	1. An apparatus for sterilizing microorganisms in a container comprising: the container, wherein the container includes a polyolefin, and wherein the container transmits light in a spectrum of from between 180 nm and 300 nm; a port coupled to the container including means through which a product within the container can be withdrawn, and a flashlamp system including means for generating high-intensity, short-duration pulses of polychromatic light in a broad spectrum, and for deactivating microorganisms within the container by illuminating the container with the pulses of light having been generated. 2. The apparatus of claim 1 wherein said container consists of a polyolefin. 3. The apparatus of claim 1 wherein said container includes polyethylene. 4. The apparatus of claim 1 wherein said product is at least one percent transmissive to light having a wavelength of 260 nanometers. 5. The apparatus of claim 1 further comprising: an interface region whereat said port is bonded to said container; said flashlamp including means for deactivating microorganisms within the port by illuminating the port with the pulses of light having been generated, and for deactivating microorganisms at the interface region by illuminating the interface region with the pulses of light having been generated. 6. The apparatus of claim 1 wherein said means for deactivating includes means for achieving a sterility assurance level of at least 10.sup.-6. 7. The apparatus of claim 1 wherein said product includes at least one product from a group of products consisting of dextrose, saline solution, and sterile water. 8. An apparatus for deactivating microorganisms in a container comprising: the container, wherein the container contains a transmissive product that transmits more than about one percent of light at a wavelength of 260 nm, and wherein the container transmits light in a spectrum of from between 180 nm and 300 nm; a port coupled to the container including means through which the product within the container can be withdrawn; and a flashlamp system including means for generating high-intensity, short-duration pulses of polychromatic light in a broad spectrum, and for deactivating microorganisms within the container by illuminating the container with the pulses of light having been generated. 9. The apparatus of claim 8 wherein said container includes a polyolefin. 10. The apparatus of claim 8 wherein said container consists of a polyolefin. 11. The apparatus of claim 8 wherein said container includes polyethylene. 12. The apparatus of claim 8 further comprising: an interface region whereat said port is bonded to said container; said flashlamp including means for deactivating microorganisms within the port by illuminating the port with the pulses of light having been generated, and for deactivating microorganisms at the interface region by illuminating the interface region with the pulses of light having been generated. 13. The apparatus of claim 8 wherein said means for deactivating includes means for achieving a sterility assurance level of at least 10.sup.-6. 14. The apparatus of claim 8 wherein said product includes at least one product from a group of products consisting of dextrose, saline solution, and sterile water. 15. An apparatus for deactivating microorganisms in a container comprising: the container, wherein the container transmits light in a spectrum of from between 180 nm and 300 nm; a port coupled to the container including means through which a product within the container can be withdrawn; and a flashlamp system including means for generating high-intensity, short-duration pulses of polychromatic light in a broad spectrum, and for deactivating microorganisms within the container and port by illuminating the container and port with the pulses of light having been generated. 16. The apparatus of claim 15 wherein said container includes polyethylene. 17. The apparatus of claim 15 wherein said product is at least one percent transmissive to light having a wavelength of 260 nanometers. 18. The apparatus of claim 15 further comprising: an interface region whereat said port is bonded to said container; and said flashlamp including means for deactivating microorganisms within the port by illuminating the port with the pulses of light having been generated, and for deactivating microorganisms at the interface region by illuminating the interface region with the pulses of light having been generated. 19. The apparatus of claim 15 wherein said means for deactivating includes means for achieving a sterility assurance level of at least 10.sup.-6. 20. The apparatus of claim 15 wherein said product includes at least one product from a group of products consisting of D5W, saline solution, and sterile water. 21. An apparatus for deactivating microorganisms in a container comprising: the container, wherein the container includes at least one port through which the product within the container can be withdrawn, and wherein the container transmits light in a spectrum of from between 120 nm and 2600 nm; and a flashlamp system including means for generating high-intensity, short-duration pulses of polychromatic light in a broad spectrum, and for deactivating microorganisms within the container by illuminating the container with the pulses of light having been generated, said means for deactivating including means for achieving a sterility assurance level of at least 10.sup.-6. 22. The apparatus of claim 21 wherein said container includes polyethylene. 23. The apparatus of claim 21 wherein said product is at least one percent transmissive to light having a wavelength of 260 nanometers. 24. The apparatus of claim 21 further comprising: an interface region whereat said port is bonded to said container; said flashlamp including means for deactivating microorganisms within the port by illuminating the port with the pulses of light having been generated, and for deactivating microorganisms at the interface region by illuminating the interface region with the pulses of light having been generated. 25. The apparatus of claim 21 wherein said product includes at least one product from a group of products consisting of D5W, saline solution, and sterile water. 26. An apparatus for sterilizing microorganisms in a container comprising: the container, wherein the container includes a blister formed therein; a backing material that together with the blister form a cavity in which is contained a contact lens and a preservative fluid; a flashlamp system including means for generating high-intensity, short-duration pulses of polychromatic light in a broad spectrum, and for deactivating microorganisms within the container by illuminating the container with the pulses of light having been generated. 27. The apparatus of claim 26 wherein said container includes a polyolefin. 28. The apparatus of claim 26 wherein said container includes polyethylene. 29. The apparatus of claim 28 wherein said container transmits light in a spectrum of from between 180 nm and 300 nm. 30. The apparatus of claim 26 wherein said preservative fluid is at least one percent transmissive to light having a wavelength of 260 nanometers. 31. The apparatus of claim 26 wherein said means for deactivating includes means for achieving a sterility assurance level of at least 10.sup.-6.

Details for Patent 5,786,598

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-23