Claims for Patent: 5,032,265

Summary for Patent: 5,032,265

Title:	Method and system for producing sterile aqueous solutions
Abstract:	A process is provided for purifying potable water to produce American Association for Advancement of Medical Instrumentation (AAMI) standard water for dialysis, United States Pharmacopeia Convention, Inc. USP XXII specifications water for injection or sterile water for injection. Potable water is passed through a plurality of treatment steps including a preliminary filtration step, a carbon adsorption module and a reverse osmosis module to produce water to the quality specified by AAMI for hemodialysis. An ion exchange filtration step is added to the steps stated above to produce USP XXII quality specifications for water for injection and a disposable sterilizing microfilter is further added to all the steps stated above to produce sterile water for injection. The process is designed such that the system is sanitized with hot water and subsequently flushed at a temperature and time that will control microbial population as specified by the user requirements without degrading the materials of construction in the treatment steps, for example at 80.degree. C. for one hour. The sterile microfilter used for the production of sterile water is a disposable device changed periodically to maintain sterility of the final solution.
Inventor(s):	Jha; Anil D. (Lexington, MA), Deming; Laura L. (Lunenburg, MA), Kuriyel; Ralf (Boston, MA)
Assignee:	Millipore Corporation (Bedford, MA)
Application Number:	07/541,010
Patent Claims:	1. A system for producing water of a quality that meets AAMI Standard water for dialysis from a potable water source which comprises: (a) a filtration means adapted to remove particulate impurities from water; (b) an adsorption means containing an adsorbent for removing chlorine and dissolved organics; (c) a reverse osmosis separation means adapted to remove organics, dissolved solids, microorganisms and pyrogens from water; (d) means for passing the potable water through said filtration means, adsorption means and said reverse osmosis separation means and; (e) means for passing heated water periodically through said filtration means, said adsorption means and said reverse osmosis means thereby to flush accumulated pyrogens and to control microorganisms within the said system. 2. A system of claim 1 wherein the potable water is passed, sequentially through steps (a), (b) and (c). 3. A system for producing USP XXII specifications grade water for injection from a potable water which comprises: (a) a filtration means adapted to remove particulate impurities from water; (b) an adsorption means containing an adsorbent for removing chlorine and dissolved organics; (c) a reverse osmosis separation means adapted to remove organics, dissolved solids, microorganisms and pyrogens from water; (d) means for passing the potable water through said filtration means, said adsorption means, said reverse osmosis means and said deionization means; and (e) means for passing heated water periodically through said filtration means, said adsorption means said reverse osmosis means and said deionization means thereby to flush accumulated pyrogens and to control microorganisms within the said system. 4. The system of claim 3 wherein the potable water is passed sequentially through steps (a), (b) and (c). 5. A system for producing USP XXII specifications grade sterile water for injection from a potable water source which comprises: (a) a filtration means adapted to remove particulate impurities from water; (b) an adsorption means containing an adsorbent for removing chlorine and dissolved organics; (c) a reverse osmosis separation means adapted to remove organics, dissolved solids, microorganisms and pyrogens from water; (d) sterile microfiltration means downstream of steps (a), (b) and (c) adapted to remove bacteria from water; (e) means for passing the potable grade water through said filtration means, said adsorption means, said reverse osmosis separation means and said sterile filtration means; and (f) means for passing heated water periodically through said filtration means, said adsorption means and said reverse osmosis means thereby to flush accumulated pyrogens and to control microorganisms within the said system. 6. The system of claim 5 wherein a deionization means adapted to remove dissolved solids from water is located downstream of said osmosis separation means, means for passing water from said reverse osmosis means through said deionization means and means for periodically passing heated water through said deionization means to flush accumulated pyrogens and to control microorganisms within the said system. 7. The system of claim 5 wherein the potable water is passed sequentially through steps (a), (b), (c) and (d). 8. A system for producing sterile peritoneal dialysis fluid from a potable water source which comprises: (a) a filtration means adapted to remove particulate impurities from water; (b) an adsorption means containing an adsorbent for removing chlorine and dissolved organics; (c) a reverse osmosis separation means adapted to remove organics dissolved solids, microorganisms and pyrogens from water; (d) sterile microfiltration means downstream of steps (a), (b), and (c) adapted to remove bacteria from water; (e) means for passing the potable grade water through said filtration means, said adsorption means, said reverse osmosis separation means, and said microfiltration means; (f) means for proportioning concentrated peritoneal fluids with water exiting said reverse osmosis means and entering said sterile microfiltration means; and (g) means for passing heated water periodically through said filtration means, said adsorption means, and said reverse osmosis means thereby to flush accumulated pyrogens and to control microorganisms within the said system. 9. The system of claim 8 wherein the potable water is passed sequentially through steps (a), (b), (c) and (d). 10. The system of claim 8 wherein said heated water also is passed periodically through means (f). 11. A system for producing sterile medical fluids from a potable water source which comprises: (a) a filtration means adapted to remove particulate impurities from water; (b) an adsorption means containing an adsorbent for removing chlorine and dissolved organics; (c) a reverse osmosis separation means adapted to remove organics, dissolved solids, microorganisms and pyrogens from water; (d) sterile microfiltration means downstream of steps (a), (b) and (c) adapted to remove bacteria from water; (e) means for passing the potable water through said first filtration means, said reverse osmosis separation means and said sterile microfiltration means; (f) means for proportioning concentrated medicament solutions with water exiting said reverse osmosis means and entering said sterile microfiltration means; and (g) means for passing heated water periodically through said filtration means, said adsorption means and said reverse osmosis means thereby to flush accumulated pyrogens and to control microorganisms within the said system. 12. The system of claim 11 wherein a deionization means adapted to remove dissolved solids from water is located downstream of said reverse osmosis separation means, said means for proportioning being adapted to dispense said medicament with water exiting from said deionization means, means for passing water from said reverse osmosis means through said deionization means and means for periodically passing heated water through said deionization means to flush accumulated pyrogens and to control microorganisms within the said system. 13. The system of claim 11 wherein the potable water is passed sequentially through steps (a), (b), (c) and (d). 14. The system of claim 11 wherein said heated water also is passed periodically through step (f). 15. The system of any one of claims 1, 3, 5, 6, 8, 11 or 12 wherein means (c) is upstream of means (b).

Details for Patent 5,032,265

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