Powered sterile solution device

Abstract

The disclosure below relates to apparatus and methods for producing medicament using sub-optimal water sources. One embodiment of the disclosure is directed to an apparatus comprising a preliminary purification component, a disinfection component, a pharmaceutical grade water preparation (PGW) component, and a drug pack. Another disclosed embodiment relates to a method for producing a peritoneal dialysis solution, comprising, passing diluent through a preliminary purification component, passing diluent through a disinfection component, passing diluent through a PGW preparation component, passing diluent through a drug pack, and collecting solute produced by the drug pack.

Description

REFERENCE TO RELATED APPLICATIONS [0001] The present application claims priority under 35 U.S.C. § 120 as a divisional of U.S. patent application Ser. No. 10 / 478,908 filed Jul. 14, 2004, which is a U.S. National Phase Application of PCT / US02 / 15325 filed May 14, 2002, which claims priority to U.S. Provisional Application No. 60 / 291,155 filed May 14, 2001. All of the priority applications are hereby incorporated by reference in their entirety.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The apparatus and methods disclosed herein relate to the preparation of sterile water for various medical uses. An exemplary medical use is the preparation of peritoneal dialysate solutions or hydration fluids under sub-optimal conditions. [0004] 2. Description of the Related Art [0005] The preparation of medicaments in the field or under sub-optimal conditions is complicated by the absence of clean water supplies. Existing water purification devices that produce pharmaceutical g...

AI Technical Summary

Problems solved by technology

The preparation of medicaments in the field or under sub-optimal conditions is complicated by the absence of clean water supplies.

Existing water purification devices that produce pharmaceutical grade water (PGW) in remote locations have limited production capacity, both by limiting flow rates and by reducing product life span.

The purification capacity of such devices can become severely limited when used to purify significantly contaminated water sources.

In fact, even potable water quality standards for municipal water treatment throughout the developed world allow widely variable levels of contamination that render such water supplies unsuitable for use in the preparation of medicaments, without further purification.

Disinfection alone is not adequate to achieve PGW.

Elevated levels of dissociable ions are acceptable in municipally treated waters for drinking but are potentially hazardous to health if administered in non-physiologic levels.

The by-products of microbial contamination even following disinfection are potentially life threatening.

Endotoxins derived from gram negative bacteria represent a life threatening hazard resulting from pyrogenic shock.

PGW have limits that do not apply to maximal potable water standards for particulate matter which severely limits the capacity of remote site PGW purification systems.

The acceptable levels of organic contaminants in drinking water may exceed acceptable levels in a therapeutic PGW due to the potential toxicity of intravenous administration of these agents.

This problem is exacerbated with the use of available water with uncontrolled organic contamination.

Without preliminary removal of organic contaminants, a POW system would have severely reduced purification capacity.

Dissolved solids constitute a significant contaminant in water.

The deionization capacity of a PGW system would be markedly limited without preliminary deionization of the source water.

Perhaps the greatest acute hazard to ingestion of available water results from the potentially infectious agents that may be present therein.

Some microbial agents, however, have the capacity to grow through filters, thus rendering them non-sterile.

These forms of filtration require expansive mechanical generation of high pressure and thus entail an extensive power requirement.

These devices, however, do not remove these agents or cell debris from the product water.

For production of water-based, injectable fluids, bacterial-by products represent a significant hazard and must be removed to prevent pyrogenic shock and potential death.

The purification capacity of PGW systems is limited, without a preliminary filtration of these agents in combination with a disinfection step, which renders the microbial agents non-replicative.

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