Late 1996, the U. S. Pharmacopoeia (USP) established new rules (USP 23) for the acceptance of USP grade of water (deionized or distilled). Previously, the water was qualified by meeting certain levels of chemical assays. Performing these assays was both costly and time-consuming. When vessels are cleaned to USP standard, the final rinse water leaving the vessel must have meet USP specifications. This means that any vessel used for manufacturing or development has to be washed so that the final rinse meets these specifications. It is plain to see that this added a large cost to production and added time delay as well.

Under the new rules of USP 23, one can now evaluate the water quality on the basis of conductivity in place of the multiple element analysis as long as the conductivity level is at or below the specified level. The industry wants to be able to use this method because it is easier and quicker. Traditional sampling is also eliminated for many requirements since flow-through conductivity sensors can be mounted in the vessel discharge port.

The USP 23 specification is divided into three separate enumerated stages.

The water qualifies according to each Stage specification according to USP-23.

In Stage 1, one determines the temperature of the water and the non- temperature compensated conductivity reading. The temperature is rounded down to the nearest 5° C and compared to a table to determine the maximum conductivity reading. The water is acceptable if the tested conductivity reading is less than the maximum. Stage 2 testing is performed if the water failed Stage 1 specification.

In Stage 2, one uses the same water, at least 100 ml, and adjusts the temperature to 25° C. The sample is vigorously agitated, while tested for conductivity. The conductivity is noted when the change in conductivity, due to uptake of carbon dioxide from the air, is less than 0. 1 S/cm per five minutes. The water is acceptable if the conductivity is not greater than 2. 1, uS/cm. If not, one proceeds to Stage 3.

In Stage 3, one adds 0. 3 mol saturated potassium chloride per 100 ml water.

This needs to be done within 5 minutes of Stage 2 and at 25° C. The pH is determined to the nearest 0. 1 pH unit as directed under pH <791>. The pH is compared to a table that gives the maximum conductivity for pH. The water passes if the ending conductivity from Stage 2 is less than the maximum allowable conductivity determined from the pH tables. The water is unacceptable if the pH is outside the range of 5. 0 to 7. 0 or the conductivity exceeds to the maximum conductivity allowed in Stage 3.

The new testing procedure has many benefits. However, there are no commercially available standards at these low levels with which to calibrate the sensor. Traditional packaging will not do. Glass bottles are mineral (sodium oxide) and will dissolve to a small extent into the standard raising the level and contaminating the standard. Plastic bottles are permeable to the air which contains carbon dioxide. The carbon dioxide reacts with the water forming carbonic acid resulting in elevated conductivity. Rigid bottles have a further disadvantage in that when some of the solution is removed, the balance is subjected to contamination from the air which displaces the liquid.

What is needed is a new vessel that does not dissolve into the substance contained therein. Further that vessel should be designed to preclude air contact between the substance contained therein and the ambient air, regardless of the volume of substance removed therefrom. This container will obviously have significance broader than use in pharmacopoeia related industries. For instance, a container that precludes contact with air can be used with wine or beer to prevent oxidation of the beverage.

SUMMARY OF THE INVENTION The present invention is a container including a containing mechanism and a removal mechanism. The containing mechanism is for containing a substance, protecting the substance from impurities obtained through the air or dissolving of the container into the substance. The removal mechanism provides a manner for release of the substance, while avoiding replacement of the removed substance with air.

The containing mechanism is preferably in the form of a pouch and is formed of a laminate. The laminate is preferably formed of either polyester or nylon together with layers of polyethylene, aluminum foil and a sealing layer. These layers should be fashioned in such a manner that the container is deformable to receive the substance therein.

The removal mechanism preferably includes a one-way valve. The one-way valve should preclude air displacement, e. g. replacement of a removed portion of the substance with air. The one-way valve should provide for release of a portion of the substance in a controlled manner.

The substance is preferably a liquid such as a standard. The standard may be selected from the group : pH calibrating buffers, conductivity standards, turbidity standards, ion standards and combinations thereof.

The present invention also includes a method of containing a substance including the steps of : containing a substance in a container, precluding significant contact between air and the substance in the container, precluding significant dissolving of the container into the substance, and removing a portion of the substance from the container, while precluding substantial air displacement of the portion being removed. The container and substance are preferably as described above.

DETAILED DESCRIPTION OF THE DRAWINGS Figure 1 is a prospective view of the present invention ; and Figure 2 is a cross sectional view taken along the lines 2-2 of Figure 1.

DETAILED DESCRIPTION OF THE INVENTION As shown in Figure 1, the present invention 10 is a container including a containing mechanism, preferably a pouch portion 12 and a removal mechanism 13, which preferably includes a valve 14. The pouch portion 12 may contain a standard 16 therein. The pouch 12 and valve 14 are joined in such a manner as to preclude contamination of the substance 16 contained therein either through degradation of the container 10 or interaction between air and the substance 16.

The pouch portion 12 may be any of a variety of sizes or shapes. A small pouch 12 may hold single uses of substances 16, making other preferred design features unnecessary. The pouch 12 preferably is flexible and collapses so that it may hold multiple uses of the substance 16. Flexibility of the pouch 12, e. g. collapsibility, allows use of a portion of the substance 16 contained therein, while allowing some substance to remain in the pouch 16 for use at another time. Should the container not collapse another material, most likely air, will take the place of the portion of the substance 16 which has been removed via simple displacement concepts and thereby degrade the substance 16. The preferred size of the pouch 12 is one gallon, although the pouch 12 may hold substantially more or substantially less.

The pouch 12 is for containing a substance 16 and protecting the substance 16 from impurities obtained through the air or dissolving of the pouch 12 into the substance 16. The pouch 12 is preferably made of a laminate to preclude air passing through the walls 18 of the pouch 12. The laminate preferably includes a layer 20 of either polyester, nylon or both together with layers of polyethylene 22, aluminum foil 24 and a sealing layer 26. While these layers 20,22, 24,26 are preferred, one skilled in the art may find equivalent materials that do not dissolve in the substances 16 contained within the pouch 12 and preclude air from passing through the walls 18. Such equivalent material (s) may replace one or more layers.

The pouch 12 may be shaped in a variety of manners. The preferred shape is any shape that has a minimum amount of creasing on the inside 28 of the pouch 12 and forms a sturdy base or supportive bottom 30. The creasing should be avoided to minimize opportunity for dirt and other contamination to get caught inside the pouch 12. The base 30, while less important, provides for a convenient mode of storage both temporary and long term.

The removal mechanism 13 provides a manner for release of the substance 16, while avoiding replacement of the removed substance 16 with air. The removal mechanism 13 preferably includes a one-way valve 14, which is sealed to the pouch 12. The pouch 12 is to be sealed closed except for an opening 32 through which the valve 14 extends. The opening 32 should circumscribe and seal about the valve 14.

Such seal may be formed with hot melting, adhesive or other method known in the art of making seals.

The valve 14 should preclude air displacement and should not easily dissolve into the substance 16. That is, when a portion of the substance 16 is removed from the pouch 12 an incidental vacuum is created. That vacuum should collapse the sides of the pouch 12, which is preferably designed to be collapsible, instead of drawing air into the pouch 12. Air can contaminate the substance 16 and is therefore deemed to be undesirable. The one-way valve 14 should provide for release of a portion of the substance 16 in a controlled manner. A preferred valve 14 should not dissolve into the substance 16 and should not be air permeable.

The substance 16 is preferably in liquid form and may further be a standard used to calibrate equipment. A couple examples of standards include, pH calibrating buffers, conductivity standards, turbidity standards, ion standards and combinations thereof. Alternately, the substance 16 may be a material that degrades either by dissolving of the container 10 or by introduction of air into the substance 16. Two examples, include wine and beer. This invention is intended to be used in conforming with U. S. Pharmacopoeia rules and regulations, although it can easily be seen that this inventive container has importance outside such industry.

The present invention 10 also includes a method of containing a substance 16 including the steps of : containing a substance 16 in a container 10, precluding significant contact between air and the substance 16 in the container 10, precluding significant dissolving of the container 10 into the substance 16, and removing a portion of the substance 16 from the container 10, while precluding substantial air displacement of the portion being removed. The container 10 and substance 16 are preferably as described above.

Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize changes may be made in form and detail without departing from the spirit and scope of the invention.