Glossary

Water rendered suitable for pharmaceutical purposes by using unit operations that include deionization, distillation, ion-exchange, reverse osmosis, filtration, or other suitable purification procedures. It meets rigid specifications for chemical purity, the requirements of the Federal Environmental Protection Agency (EPA) with respect to drinking water, and it contains no added substances. Cannot be used as raw material for parenterals. Common uses are: a rinse for equipment, vials, and ampoules, and as make up for cosmetics, bulk chemicals, and oral products. For FDA acceptance, purified water must contain less than 0.5 mg/l of TOC (Total Organic Carbon), and less than 100 CFU (Colony Forming Units).

A nitrogen-containing, double-ring, basic compound that occurs in nucleic acids. The purines in DNA and RNA are adenine and guanine.

The ratio of desirable to undesirable components in a liquid as determined on a weight basis per unit volume of sample.

Process User Requirements

Photovoltaics

Polyvinyl Acetate

Polyvinyl Alcohol

Polyvinyl Acetate

Polyvinyl Butyral (butyrate)

Polyvinyl Chloride

The largest volume of the vinyl family of plastics. Overall it has excellent basic properties, may be easily processed and welded, and is exceptionally economical in cost. Homopolymers grades of PVC comprise over 80% of all PVC used, and contain 56.8% chlorine by weight. When the chlorine content is increased to about 67% its heat deflection temperature at 264 psi increases from 155°F (68°C) to 218°F (103°C). Because PVC is a thermally sensitive thermoplastic compounding ingredients such as heat stabilizers, lubricants, fillers, plasticizers, impact modifiers, pigments, and processing aids must be added to make it processible. PVC is prone to produce extractables during start-up in high purity water.

Polyvinyl Chloride Acetate

Chlorinated Polyvinyl Chloride

Polyvinylidene Chloride

Polyvinylidene Fluoride (Kynar®, Sygef®)

Homopolymer and/or copolymer material composed of carbon, hydrogen, and fluorine.

A thermoplastic fluoropolymer with a melt point of 352°F (178°C), and a wide service range from -40°F (-40°C) to 284°F (140°C). It has a very linear chemical structure, and is similar to PTFE with the exception of not being fully fluorinated, i.e. having 3% hydrogen by weight. Its drawbacks in the area of chemical resistance include unsuitability with strong alkalis, fuming acids, polar solvents, amines, ketones, and esters. It has a high tensile strength as well as a high heat deflection temperature. It is readily weldable, offers high purity qualities, and is resistant to permeation of gases. PVDF is a relatively inert material and contributes little in the way of contamination to pharmaceutical water.

Polyvinyl Fluoride

Polyvinyl Carbazol

Silicone Rubber

Pneumonia Virus of Mice

Polyvinyl Alcohol

Polyvinylpyrrolidone

Purified Water

Powder X-Ray Diffraction