Claims for Patent: 6,656,423

Summary for Patent: 6,656,423

Title:	Sterile water generator
Abstract:	A sterile water generator (B) generates a stream of sterile water on demand. A water heater (130) heats incoming, unsterile water to a sufficient temperature to achieve sterilization of the water. The sterile water is then passed through a heat exchanger (110) which transfers excess heat from the sterile water to the incoming water. This reduces the energy consumption of the water heater and reduces the temperature of the sterile water ready for use. The sterile water is delivered to a site (A), at which the water is to be used, through a sterile water delivery pathway (C) to avoid recontamination of the water. A first portion (162) of the pathway is pre-sterilized by flowing steam or hot water, generated by the water heater, along the pathway (C). A second portion (212) of the pathway is sterilized with a liquid antimicrobial from the site. The first and second portions of the pathway have at least one common leg (164).
Inventor(s):	Joslyn; Larry J. (Mentor, OH)
Assignee:	Steris Inc. (Temecula, CA)
Application Number:	09/498,864
Patent Claims:	1. A sterile water generator comprising: a water heater which receives incoming water and heats the water to a sufficient temperature to sterilize the water; a presterilized water delivery pathway passing through a heat exchange for delivering the sterile water from the water heater to a rinse water inlet to a low temperature sterilizer in which the sterile water is to be used, the presterilized pathway being sterilized along at least a first portion of its length by heated water or steam from the water heater; means for chemically sterilizing a second portion of the length of the water delivery pathway; a control for controlling at least the water heater and a flow of cooling water through the heat exchanger to first thermally sterilize the presterilized water pathway and then supply low temperature sterile water through the presterilized water pathway to the rinse water inlet of the low temperature sterilizer. 2. The A sterile water generator comprising: a water heater which receives incoming water and heats the water to a sufficient temperature to sterilize the water; a presterilized water delivery pathway passing through a heat exchange for delivering the sterile water from the water heater to a rinse water inlet to a low temperature sterilizer in which the sterile water is to be used, the presterilized pathway being sterilized along at least a portion of its length by heated water or steam from the water heater; a first valve, the first valve having first and second positions: (a) in the first position the first valve connects the presterilized water delivery pathway with the site; and (b) in a second position the first valve connects the presterilized water delivery pathway with a drain line, for passing a thermal sterilization fluid through the presterilized water delivery pathway to the drain line; and a control for controlling at least the water heater and a flow of cooling water through the heat exchanger to first thermally sterilize the presterilized water pathway and then supply low temperature sterile water through the presterilized water pathway to the rinse water inlet of the low temperature sterilizer. 3. A sterile water generator comprising: a water heater which receives incoming water and heats the water to a sufficient temperature to sterilize the water; a sterile water delivery pathway for delivering the sterile water from the water heater to a site at which the sterile water is to be used, the sterile pathway being presterilized along at least a portion of its length by heated water or steam from the water heater; a first valve, the first valve having first and second positions: a) in the first position the first valve connects the sterile water delivery pathway with the site; and b) in a second position the first valve connects the sterile water delivery pathway with a drain line, for passing a thermal sterilization fluid through the sterile water delivery pathway to the drain line; and a second valve, the second valve having first and second positions: a) in the first position, the second valve connects the water heater with the first valve, allowing sterile water to flow through the sterile water delivery pathway to the site when the first valve is in the first position; b) in the second position, the second valve connects a source of a decontamination fluid with the first valve for sterilizing a portion of the sterile water delivery pathway between the first valve and the site when the first valve is in the second position. 4. The sterile water generator of claim 1, further including a residence time chamber which is dimensioned to retain the water heated by the water heater for a sufficient time for sterilization of the water prior to passing the sterile water through the heat exchanger. 5. The sterile water generator of claim 4, wherein the residence time chamber is integral with the water heater. 6. The sterile water generator of claim 1, further including a filter in the presterilized water delivery pathway for filtering precipitated salts and entrained endotoxins from the sterile water. 7. A sterile water generator comprising: a water heater which receives incoming water and heats the water to a sufficient temperature to sterilize the water; a sterile water delivery pathway for delivering the sterile water from the water heater to a site at which the sterile water is to be used, the sterile water delivery pathway being presterilized along at least a first portion of its length by heated water or steam from the water heater, a second portion of the sterile water delivery pathway being chemically presterilized; and a sterile sample port for obtaining a sample of the sterile water. 8. The sterile water generator of claim 1, wherein the presterilized water delivery pathway includes a temperature detector for ensuring that water passing through the presterilized water delivery pathway during a pathway sterilization step is at a sufficient temperature for sterilizing the presterilized water delivery pathway. 9. A method of supplying sterile water through a sterile fluid delivery pathway, the method comprising: a) heating a liquid to generate a first thermal sterilizing fluid; b) passing the first sterilizing fluid along at least a first portion of a sterile fluid delivery pathway to effect thermal sterilization of the first portion of the pathway; c) passing a second sterilizing fluid along a second portion of the sterile fluid delivery pathway to effect sterilization of the second pathway portion, the first and second portions each having (1) at least one common portion over which both the first and second sterilizing fluids are passed and (2) a non-common portion over which only one of the first and second sterilizing fluids pass; d) generating sterile water by heating water; and e) passing the sterile water along the sterilized sterile fluid delivery pathway. 10. A method of supplying sterile water through a sterile fluid delivery pathway, the method comprising: a) passing a first sterilizing fluid along a first portion of a sterile fluid delivery pathway to effect sterilization of the first portion of the pathway, the first sterilizing fluid being one of hot water and steam; b) passing a second sterilizing fluid along a second portion of the sterile fluid delivery pathway to effect sterilization of the second pathway portion, the second sterilizing fluid including an antimicrobial liquid selected from the group consisting of peracetic acid and hydrogen peroxide, the first and second portions being non-coextensive; c) steps (a) and (b) being performed non-concurrently such that the sterile pathway is in part thermally sterilized and in part chemically sterilized; and d) passing sterile water along the sterilized sterile fluid delivery pathway. 11. The method of claim 9, wherein step a) includes: maintaining the first sterilizing fluid at an above atmospheric pressure. 12. The method of claim 9, wherein step c) includes sterilizing the second portion of the fluid pathway by passing an antimicrobial liquid along the second portion of the pathway. 13. The method of claim 12 further including; discarding the antimicrobial liquid that has passed over the second passageway portion. 14. The method of claim 12, wherein the antimicrobial liquid is selected from the group consisting of peracetic acid and hydrogen peroxide. 15. The method of claim 9, wherein step c) includes: passing a portion of the first sterilizing fluid through a sample port to sterilize the sample port. 16. A method of supplying sterile water through a sterile fluid delivery pathway, the method comprising: sterilizing a fluid delivery pathway including: passing heated water or steam along at least a first portion of a the fluid delivery pathway to effect sterilization of the first portion of the pathway; discharging the heated water or steam before it reaches a second portion of the pathway; passing sterile water along the sterilized fluid delivery pathway; entraining endotoxins in the sterile water with precipitating salts; and filtering the precipitating salts and endotoxins from the sterile water. 17. The method of claim 16, wherein the step of filtering the precipitating salts includes passing the sterile water through a filter and wherein step b) further includes: sterilizing the filter. 18. A method of decontamination comprising: sterilizing at least a portion of a rinse fluid delivery pathway with heated water or steam; contacting items to be decontaminated with a decontaminant fluid; sterilizing at least a remaining portion of the rinse fluid pathway with the decontaminant fluid which decontaminates the items; and passing rinse fluid through the rinse fluid pathway and contacting the decontaminated items with the rinse fluid. 19. The method of claim 18, wherein the flowing step further includes: cooling the rinse fluid with cold water received for heating. 20. A decontamination system comprising: a vessel for receiving items to be sterilized; a source of an antimicrobial agent connected with the vessel which supplies the antimicrobial agent to the vessel for decontaminating the items in the vessel; and a thermal sterile water generator connected with the vessel by a sterile water delivery pathway which supplies sterile rinse water to the vessel for rinsing the decontaminated items, only a portion of the sterile water delivery pathway being sterilized with heated water from the thermal sterile water generator. 21. The system of claim 20, further including: an antimicrobial agent reservoir; a fluid flow loop through which the antimicrobial agent flows from the antimicrobial agent reservoir to the vessel and from the vessel back to the reservoir; a source of the antimicrobial agent connected with at least one of the fluid flow loop and the reservoir; and a water inlet connected with the fluid flow loop upstream of the vessel, the thermal sterile water generator being connected to the water inlet to supply sterile rinse water thereto. 22. The system of claims 20, further including: a means other than the heated water from the thermal sterile water generator for sterilizing the portion of the sterile water delivery pathway left unsterilized by the heated water.

Details for Patent 6,656,423

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