Glossary

This classification is based on responses to a series of in vivo tests for which extracts, materials and routes of administration are specified. Six Plastic Classes are defined:1.Class I – Uses a specified dosage of an extract of sample in Sodium Chloride Injection applied either intravenously or intracutaneously into a mouse or a rabbit.2.Class II – Same as Class I but in addition uses an extract of sample in 1 in 20 Solution of Alcohol in Sodium Chloride Injection applied either intravenously or intracutaneously into a mouse or a rabbit.3.Class III – Same as Class II but in addition uses an extract of sample in Polyethylene Glycol 400, and an extract of sample in Vegetable Oil, both applied either intraperitoneally or intracutaneously into a mouse.4.Class IV – Same as Class II but in addition uses an extract of sample in Vegetable Oil applied intraperitoneally or intracutaneously into a mouse or a rabbit. Also uses implant strips of sample into a rabbit.5.Class V – Same as Class II but in addition uses an extract of sample in Polyethylene Glycol 400, and an extract of sample in Vegetable Oil applied intraperitoneally or intracutaneously into a mouse or a rabbit.6.Class VI – Same as Class V but in addition uses implant strips of sample into a rabbit.These tests are designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. Three tests are described:1.Systemic Injection Test – Designed to determine the systemic biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.2.Intracutaneous Test – Designed to determine the local biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.3.Implantation Test – Designed to evaluate the reaction of living tissue to the plastic and other polymers by the implantation of the sample (specimen under test) itself into animal tissue.With the exception of the Implantation Test, the procedures are based on the use of extracts that, depending on the heat resistance of the material, are prepared at one of the three standard temperatures: 50°, 70°, and 121°. Therefore, the class designation of a plastic must be accompanied by an indication of the temperature of extraction e.g., IV - 121°, which represents a class IV plastic extracted at 121°).

The majority of the primary biological reference preparations referred to in the European Pharmacopeia are the appropriate International Standards and Reference Preparations established by the World Health Organization (WHO). Because these reference materials are usually available only in limited quantities, the Commission has established Biological Reference Preparations (indicated by the abbreviation BRP) where appropriate. Where applicable, the potency of the Biological Reference Preparation is expressed in International Units. For some Biological Reference Preparations, where an international standard or reference preparation does not exist, the potency is expressed in European Pharmacopeia Units.

The US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) in their Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets – Third Edition – September 2007, Section III, Biological Safety Cabinets, defines three classes of biological safety cabinets, which are the primary means of containment developed for working safely with infectious microorganisms. BSCs are designed to provide personnel, environmental and product protection when appropriate practices and procedures are followed. The three kinds of biological safety cabinets are designated as Class I, Class II, and Class III, and they have been developed to meet varying research and clinical needs:Class I BSC – The Class I BSC provides personnel and environmental protection, but no product protection. It is similar in air movement to a chemical fume hood, but has a HEPA filter in the exhaust system to protect the environment. In the Class I BSC, unfiltered room air is drawn across the work surface. Personnel protection is provided by its inward airflow as long as a minimum velocity of 75 linear feet per minute (lfpm) is maintained through the front opening. Because product protection is provided by the Class II BSCs, general usage of the Class I has declined. However, in many cases, Class I BSCs are used specifically to enclose equipment (e.g., centrifuges, harvesting equipment or small fermenters), or procedures with potential to generate aerosols (e.g., cage dumping, culture aeration or tissue homogenation).Class II BSC – The Class II (Types A1, A2, B1 and B2) BSCs provide personnel, environmental and product protection. Airflow is drawn into the front grille of the cabinet, providing personnel protection. In addition, the downward laminar flow of HEPA-filtered air provides product protection by minimizing the chance of cross-contamination across the work surface of the cabinet. Because cabinet exhaust air is passed through a certified HEPA filter, it is particulate-free (environmental protection), and may be recirculated to the laboratory (Type A1 and A2 BSCs) or discharged from the building via a canopy connection. Exhaust air from Types B1 and B2 BSCs must be discharged to the outdoors via a hard connection.Class III BSC – The Class III BSC was designed for work with highly infectious microbiological agents and for the conduct of hazardous operations and provides maximum protection for the environment and the worker. It is a gas-tight (no leak greater than 1x10-7 cc/sec with 1% test gas at 3 inches pressure Water Gauge) enclosure with a non-opening view window. Access for passage of materials into the cabinet is through a dunk tank, that is accessible through the cabinet floor, or double-door pass-through box (e.g., an autoclave) that can be decontaminated between uses. Reversing that process allows materials to be removed from the Class III BSC safely. Both supply and exhaust air are HEPA filtered on a Class III cabinet. Exhaust air must pass through two HEPA filters, or a HEPA filter and an air incinerator, before discharge to the outdoors. Airflow is maintained by an exhaust system exterior to the cabinet, which keeps the cabinet under negative pressure (minimum of 0.5 inches of water gauge). “The exhaust fan for the Class III cabinet is generally separate from the exhaust fans of the facility ventilation system”.

A class of drugs based on proteins that have a therapeutic effect. These large protein molecules – which are composed of more than 1,300 amino acids and can be as heavy as 150,000 g/mol (or 150 kDa) – are essentially copies or optimized versions of endogenous human proteins.(also see: Biopharmaceutical)

Therapeutic or diagnostic products generated and purified from natural sources.

Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of diseases or injuries of man.

A measurement of a variable related to a disease that may serve as an indicator or predictor of that disease. Biomarkers are parameters from which the presence or risk of a disease can be inferred, rather that being a measure of the disease itself.

The entire assemblage of living organisms (both plant and animal), of a particular region considered collectively. As commonly used in biotechnology, refers to the use of cellulose, a renewable resource, for the production of chemicals that can be used to generate energy or as an alternative feedstocks for the chemical industry to reduce dependence of nonrenewable fossil fuels.

1. The cell mass produced by a population of living organisms.2. The organic mass that can be used either as a source of energy or for its chemical components.3. All the organic matter that derives from the photosynthetic conversion of solar energy.

Renewable organic materials, such as wood, agricultural crops or wastes, and municipal wastes, especially when used as a source of fuel or energy. Biomass can be burned directly or processed into biofuels such as ethanol and methane.

Organic matter grown by the photosynthetic conversion of solar energy.

Any kind of energy that uses a biological organism (plant or animal) as its source.(also see: Biomass Energy Fuels)

Biomass energy fuels may include a wide variety of items, such as animal manure, landfill waste, wood pellets, vegetable oil, algae, crops like corn, sugar, switchgrass and other plant material -- even paper and household garbage.Biomass fuel can be converted directly into heat energy through combustion. In other cases, biomass is converted into another fuel source; examples include ethanol gasoline made from corn, or methane gas derived from animal waste.

Biological molecules, such as proteins and complex sugars, used to make medical devices, including structural elements used in reconstructive surgery.

Testing of persons to find out whether a change in a body function might have occurred because of exposure to a hazardous substance.

Physical and chemical processes that occur within a cell or an organism; for example, the conversion of nutrients into energy.

Identifying information based on a physical characteristic (e.g., a fingerprint).

A method of identifying a person's identity based on measurement of the indivdual's physical feature(s) or repeatable action(s) where features and/or are both unique to that individual and measurable.

A method of verifying an individual’s identity based on measurement of his/her physical feature(s) or repeatable action(s) where those features and/or actions are both measurable and unique to that individual. The main types of biometrics are: face recognition, finger scanning, hand geometry, finger geometry, iris recognition, palm, retina, signature, and voice recognition.

An interscience discipline for constructing artificial systems, which resemble or have the characteristics of living systems.

A therapeutic product made through the genetic manipulation of living things or their cells, including (but not limited to) proteins and monoclonal antibodies, peptides, and other molecules that are not chemically synthesized, along with gene therapies, cell therapies, and engineered tissues.

Ethical pharmaceutical drugs derived through bioprocessing.

Any process that uses complete living cells or their components (e.g., enzymes, chloroplasts) to effect desired physical or chemical changes.

Process that uses complete living cells or their components (e.g., enzymes, chloroplast) to effect desired physical or chemical changes.