Claims for Patent: 4,666,722

Summary for Patent: 4,666,722

Title:	Sterile cooling method
Abstract:	Disclosed is a sterilizing apparatus adapted to practice methods of sterile cooling of packaged food products or fluids. Following sterilization a variety of procedures to effect sterile cooling are presented. Sterile cooling is accomplished by sterile fluids, such as water, a solution of selected chemicals and water or sterile air which also may be combined with sterilizing gases.
Inventor(s):	Creed; Sherman H. (Fresno, CA), Beverly; Robert G. (Los Gatos, CA)
Assignee:	FMC Corporation (Chicago, IL)
Application Number:	06/713,146
Patent Claims:	1. A method of sterile cooling and reducing the internal pressure of sterilized packages supported in a car having an overflow port by condensing head space gases in the packages, said cooling commencing after said packages have been initially heated to a sterilizing temperature by a sterile heating fluid introduced from a sterile environment, said method comprising the steps of: maintaining the packages submerged in the heating fluid in the cart at a temperature substantially equal to the selected sterilizing temperature, moving the car and the submerged packages into a sterilized discharge chamber, sealing the chamber from said sterile environment, displacing the heated fluid from the car at substantially sterilizing temperature by introducing sterile cooling water ranging in temperature from about 70.degree. to 150.degree. Fahrenheit into the car causing the heated fluid and cooling water to overflow from the car for a period of time sufficient to condense condensible head space gases in the packages, opening the discharge chamber, moving the car and packages in the cooling water out of the discharge chamber, and continue cooling outside the discharge chamber while the packages remain submerged in the sterile cooling water. 2. The method of sterile cooling according to clam 1 wherein said discharged chamber is sterilized by steam before the sterilized packages are introduced therein. 3. The method of sterile cooling according to claim 1 wherein sterilization of said discharge chamber is affected by filling the chamber with water at a temperature of 212.degree. Fahrenheit before the sterilized packages are introduced therein. 4. The method of sterile cooling according to claim 1 wherein sterilization of the discharge chamber is affected by connecting the chamber to a source of superheated steam before the sterilized packages are introduced therein. 5. The method of sterile cooling according to claim 1 wherein sterilization of the discharge chamber is affected by connecting the chamber to a chemical sanitizing solution before the sterilized packages are introduced therein. 6. The method of sterile cooling according to claim 1 wherein the sterile cooling water affecting displacement of the heated fluid at substantially sterilizing temperature contains a sanitizing chemical in solution before the sterilized packages are introduced into the discharge chamber. 7. A method of sterile cooling and condensing head space gases in packages thermally processed by a heated sterilizing fluid when the packages are supported in a car having an overflow port when in one chamber and thereafter introducing the car and packages into another communicating chamber isolatable from said one chamber while the packages remain immersed in the heated sterilizing fluid in the car, said method comprising the steps of: pressurizing said another chamber with sterile gaseous fluid at a pressure substantially equal to the pressure in said one chamber, moving the car with the immersed packages therein into said another isolatable chamber and thereafter isolating the car and immersed packages from said one chamber, displacing the heated sterilizing fluid from said car and said another chamber in which the packages are immersed with a sterile cooling fluid for cooling the packages and to effect condensation of head space gases, transferring the car and cooled packages into a flowing stream of sterile gaseous fluid to effect further sterile cooling of the packages, and restricting the flow of sterile gaseous fluid for increasing the pressure thereof for precluding contact of the packages by a contaminated environment when in said sterile gaseous stream. 8. The method according to claim 7 wherein said another chamber is sterilized following movement of the immersed packages to the sterile gaseous stream. 9. The method according to claim 7 wherein sterilization of said another chamber is affected by injecting a fluid selected from the group consisting of saturated steam, superheated steam, ozone, hydrogen peroxide and chloride into said another chamber while venting non-sterile air to the atmosphere. 10. The method of claim 7 wherein the packages being introduced in said one chamber and thereafter introduced into said another chamber are immersed and maintained immersed in water at a sterilizing temperature while being displaced from their entry toward the exit of said one chamber, and displacing the water at sterilizing temperature with sterile cooling water as the packages approach the exit of said one chamber. 11. The method of claim 10 wherein the packages, prior to being introduced in said one chamber reside in an entry lock pressurized to a level substantially equal to the pressure in said one chamber and preheated by being immersed in water at a temperature lower than sterilizing temperature. 12. The method of claim 10 wherein the packages are successively immersed in sterile cooling water at successively lower temperature than the temperature of the sterilizing water as the packages are displaced toward the exit of said one chamber. 13. The method of claim 10 wherein the sterile cooling water contains hydrogen peroxide, ozone, or chloride. 14. The method of claim 10 wherein the immersed cooled packages are located in said another chamber in the form of a sterilized discharge lock, communicating with said one chamber, where further sterile cooling, by sterile air and sterile water occurs. 15. The method of sterile cooling product filled and sealed packages supported in a sterile water filled car having an overflow port after being sterilized in hot water in a pressure sterilizing apparatus having an inlet lock, a sterilizing chamber and a discharge lock, comprising the steps of: sterilizing the discharge lock; moving the sterilized packages from the sterilizing chamber into the discharge lock while being subjected to an overriding air pressure; sealing the car and packages within said lock; directing cool sterile water into the car for causing the hot water to overflow from the car until the temperature of the water in the car is maintained at a temperature below the boiling point of the water; opening the discharge lock; and moving the car with sterile cooling water and submerged sterilized packages therein out of the discharge lock for continued cooling of the packages while submerged within the sterile water in the car.

Details for Patent 4,666,722

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