Claims for Patent: 9,370,802

Summary for Patent: 9,370,802

Title:	Cleaning and sterilizing method for ultrapure water manufacturing system
Abstract:	In a method of cleaning and sterilizing an ultrapure water manufacturing system including an ultrapure water manufacturing apparatus, a point of use of ultrapure water, and an ultrapure water channel connecting the ultrapure water manufacturing apparatus and the point of use, a cleaning and sterilizing process including an alkali cleaning step for cleaning at least part of the inside of the system with alkaline solution and a sterilizing step for sterilizing the system with sterile water after the alkali cleaning is treated twice or more. By treating the cleaning and sterilizing process twice or more, metals, organic substances, particles, and bacteria inside the ultrapure water manufacturing system can be highly efficiently removed, and thereby ultrapure water satisfying required water quality can be produced within a short period of time after the cleaning and sterilizing.
Inventor(s):	Yokoi; Ikunori (Tokyo, JP)
Assignee:	KURITA WATER INDUSTRIES LTD. (Tokyo, JP)
Application Number:	12/450,502
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,370,802
Patent Claims:	1. A method of cleaning and sterilizing an ultrapure water manufacturing apparatus, a point of use (POU) of ultrapure water, and an ultrapure water channel connecting the ultrapure water manufacturing apparatus and the point of use, the method comprising: an alkali cleaning step for supplying alkaline solution to at least part of an inside of the ultrapure water manufacturing apparatus, POU and ultrapure water channel and circulating the alkaline solution therein, thereby cleaning the at least part of the inside of the ultrapure water manufacturing apparatus, POU, and ultrapure water channel, followed by draining the alkaline solution from the at least part of the inside of the ultrapure water manufacturing apparatus, POU, and ultrapure water channel; a first flushing step for supplying water to the ultrapure water manufacturing apparatus, POU, and ultrapure water channel, thereby flushing the alkaline solution remained in the ultrapure water manufacturing apparatus, POU, and ultrapure water channel after the alkali cleaning step; a preparation step for preparing a sterilizing water by heating the water supplied in the first flushing step to a predetermined temperature or supplying hydrogen peroxide to the water supplied in the first flushing step; and a sterilizing step for circulating the sterilizing water in the ultrapure water manufacturing apparatus, POU, and ultrapure water channel, thereby sterilizing the ultrapure water manufacturing apparatus, POU and ultrapure water channel, wherein the cleaning and sterilizing steps are repeatedly performed twice or more. 2. The method according to claim 1, wherein the alkaline solution is an aqueous solution containing an ammonium salt and/or an hydroxide of an alkali metal and having a pH of 9 or more. 3. The method according to claim 1, wherein in the sterilizing step, the water is heated to the predetermined temperature of 60.degree. C. or more, and the hydrogen peroxide has a hydrogen peroxide concentration of 0.01 to 10% by weight and a temperature of 10 to 50.degree. C. 4. The method according to claim 1, wherein a period of time of the alkali cleaning step in a first cycle of the cleaning and sterilizing process is set to 0.5 hours or more, and the alkali cleaning step in a second or later cycle of the cleaning and sterilizing process is treated for a period of time longer than the alkali cleaning step in the first cycle of the cleaning and sterilizing process. 5. The method according to claim 1, wherein a period of time of the sterilizing step in a first cycle of the cleaning and sterilizing process is set to 0.5 hours or more, and the sterilizing step in a second or later cycle of the cleaning and sterilizing process is treated for a period of time longer than the sterilizing step in the first cycle of the cleaning and sterilizing process. 6. The method according to claim 1, wherein a flow rate of the alkaline solution used in the alkali cleaning step is set to 0.3 to 2.0 m/sec. 7. The method according to claim 1, wherein a flow rate of the water used in the first flushing step is set to 0.3 to 2.0 m/sec. 8. The method according to claim 1, wherein the first flushing step is carried on until a pH of the water is reduced to 8 or less and/or a resistivity of the water is increased to a predetermined value of 10 M.OMEGA.cm or more. 9. The method according to claim 1, further comprising a second flushing step for supplying another water to the ultrapure water manufacturing apparatus, POU, and ultrapure water channel, thereby flushing the sterile water out from the ultrapure water manufacturing apparatus, POU and ultrapure water channel after the sterilizing step. 10. The method according to claim 1, wherein the water supplied in the first flushing step has a resistivity of 15 M.OMEGA.cm or more, 1 .mu.g/L or less of total organic carbon (TOC), and 1 ng/L or less of metals. 11. The method according to claim 1, wherein the water supplied in the first flushing step is raw water treated with a reverse osmosis membrane device and an ion exchanger. 12. The method according to claim 1, wherein the water supplied in the first flushing step has a resistivity of 10 M.OMEGA.cm or more and 100 .mu.g/L or less of total organic carbon (TOC). 13. The method according to claim 3, wherein the water supplied in the first flushing step has a resistivity of 15 M.OMEGA.cm or more, 1 .mu.g/L or less of total organic carbon (TOC), and 1 ng/L or less of metals. 14. The method according to claim 3, wherein the water supplied in the first flushing step is raw water treated with a reverse osmosis membrane device and an ion exchanger. 15. The method according to claim 3, wherein the water supplied in the first flushing step has a resistivity of 10 M.OMEGA.cm or more and 100 .mu.g/L or less of total organic carbon (TOC). 16. The method according to claim 9, wherein a flow rate of the another water used in the second flushing step is set to 0.3 to 2.0 m/sec.

Details for Patent 9,370,802

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		2027-03-30