Glossary

Partial Tromboplastin Time

These advisories provide important drug safety information and recommendations of actions that can be taken by patients or caregivers to avoid or minimize harm from a drug. They are issued when FDA has information that would help doctors and patients make better treatment choices.

A data file issued by a certified authority to a person or company that acquires a digital signature service. The certificate includes information identifying the subject, the issuing authority, and the period of validity, and it provides the related public key. The certified authority signs the PKC digitally.

Filling of the lungs with fluid, which produces coughing and difficulty breathing.

Modified-release dosage forms showing a sequential release of the active substance(s). Sequential-release is achieved by a special formulation design and/or manufacturing method.

A procedure used to separate very large DNA molecules by alternating the direction of electric current in a pulsed manner across a semisolid gel.

List detailing incomplete construction related items.

Short piece of tubing not included in the Issued For Construction (IFC) isometric drawing or prefabricated spools, which adds a weld to make up for a dimensional discrepancy during field installation.

Polyurethane

An In vitro culture containing only one species of microorganism.

Water vapor under pressure and free from boiler additives that, when condensed, meets the requirements of USP Purified Water.

Steam that is produced by a steam generator which, when condensed, meets requirements for water for injection (WFI).

Steam that is very similar to clean steam, but contains virtually no pyrogens or endotoxins, and is defined as “uncondensed Water For Injection”. Pure steam generators are the same design as clean steam generators, usually with WFI as the feedwater. Pure steam is used in plants where pharmacopeias demand the use of WFI, such as the aseptic processing of parenterals or ophthalmic solutions. Pure steam is also used to steam sterilize WFI systems and distribution loops, where the same requirement applies.

Water that has been heated above 100°C (212°F) and vaporized in a manner that prevents source water entrainment. It is prepared from water complying with the U.S. EPA Primary Drinking Water Regulations, or with drinking water regulations of the European Union or Japan, or with WHO drinking water guidelines. It contains no added substance. The level of steam saturation or dryness, and the amount of noncondensable gases are to be determined by the Pure Steam application. Note: Pure Steam is intended for use where steam or its condensate comes in contact with the article of the preparation.

Water that has been heated above 100°C (212°F) and vaporized in a manner that prevents source water entrainment. It is prepared from water complying with the U.S. EPA Primary Drinking Water Regulations, or with drinking water regulations of the European Union or Japan, or with WHO drinking water guidelines. It contains no added substance. The level of steam saturation or dryness, and the amount of noncondensable gases are to be determined by the Pure Steam application. Note: Pure Steam is intended for use where steam or its condensate comes in contact with the article of the preparation.

Water that has been heated above 100°C (212°F) and vaporized in a manner that prevents source water entrainment. It is prepared from water complying with the U.S. EPA Primary Drinking Water Regulations, or with drinking water regulations of the European Union or Japan, or with WHO drinking water guidelines. It contains no added substance. The level of steam saturation or dryness, and the amount of noncondensable gases are to be determined by the Pure Steam application. Note: Pure Steam is intended for use where steam or its condensate comes in contact with the article of the preparation.

The concentration of carbon that escapes the sample in the gas phase during the process of sparging the sample to remove inorganic carbon prior to measuring the organic carbon.

The removal of impurities of concern.

A central part of downstream processing that takes a crude fermentation supernatant or cell homogenate (chaotic slurry of tissues and cells) and isolates the product from it in a fairly pure form.

A classification of water according to compendial standards.

USP Purified Water prepared from water complying with the quality attributes of “Drinking Water” with conductivity in accordance with stage 1, 2 and 3 tests and Conductivity Tables. Total Organic Carbon is at 0.5 mg/l. Typically, less than 100 CFU/ml (10,000 CFU/100 ml) for microbiological acceptability.

(EMEA) Water for the preparation of medicinal products other than those that require the use of water which is sterile and/or apyrogenic. Purified water which satisfies the test for endotoxins may be used in the manufacture of dialysis solutions. Purified Water is prepared by distillation, by ion exchange or by any other suitable method, that complies with the regulations on water intended for human consumption laid down by the competent authority.

USP Purified Water prepared from water complying with the quality attributes of “Drinking Water” with conductivity in accordance with stage 1, 2 and 3 tests and the following tables. Total Organic Carbon at 0.5 mg/l. Less than 100 CFU/ml (10,000 CFU/100 ml) for FDA microbiological acceptability.

Water for the preparation of medicines other than those that are required to be both sterile and , apyrogenic unless otherwise justified and athorised. Purified water in bulk is prepared by distillation, by reverse osmosis or by any other suitable method from water that coplies with the regulations on water intended for human consumption laid down by the competent authority.During production and subsequent storage, appropriate measures are taken to ensure that the total viable aerobic count is adequately controlled and monitored. Appropriate alert and action limits are set so to detect adverse trends. Under normal conditions, an appropriate action limit is a total viable aerobic count of 100 micro-organisms per millilitre, determined by membrane filtration, using agar medium S. and incubating at 30-35 °C for 5 days. The size of the sample is to be chosen in relation to the expected result.

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).