Glossary

Creutzfeldt-Jakob Disease

A vessel made from a base material having a corrosion resistant material either integrally bonded or weld metal overlaid to the base of less resistant material.

To clear liquid of suspended particles through filtration, centrifugation, or the addition of an enzyme.

(Devices). Classification by the Food and Drug Administration of medical devices according to potential risks or hazards. Separated into Class I, II and III devices. (See definitions below.)•Class I Devices: Devices subject to general control requirements (certain records and reports provided to the FDA by the manufacturer)•Class II Devices: Devices subject to general control and specific performance-based standards•Class III Devices: Devices subject to a premarket approval process that is much like the approval process for new drugs.

Classification of an area where particle count should not exceed 1,000 particles 0.5µm or larger, per cubic foot of air. (also see: (ISO) Classification)

Classification of an area where particle count should not exceed 10,000 particles 0.5µm or larger, per cubic foot of air. (also see: (ISO) Classification)

Classification of an area where particle count should not exceed 100 particles 0.5µm or larger, per cubic foot of air. (also see: (ISO) Classification)

Classification of an area where particle count should not exceed 100,000 particles 0.5µm or larger, per cubic foot of air. (also see: (ISO) Classification)

This area would have 30% efficient filtration. This classification is not specified in ISO 14644-1.

This area would have 65% efficient filtration. This classification is not specified in ISO 14644-1.

This area designation refers to the efficiency of the filters based on ASHRAE standard 52-76. These areas would have 95% efficient supply air filtration, unlike classified areas, which would have HEPA filtration. This classification is not specified in ISO 14644-1.

“For naming and describing the classes, SI names and units are preferred; however, English (U.S. customary) units may be used”. Federal Standard 209E superseded by ISO 14644-1.

Small-molecule, nonbiotech drugs produced by chemical synthesis.

Level (or the process of specifying or determining the level) of airborne particulate cleanliness applicable to a cleanroom or clean zone, expressed in terms of an ISO Class N, which represents maximum allowable concentrations (in particles per cubic meter of air) for considered sizes of particles.ISO 14644-1.NOTE1: The concentrations are determined by using equation (1) in ISO 14644-1:1999, 3.2.NOTE 2: Classification in accordance with this part of ISO 14644 is limited to the range extending from ISO Class 1 through ISO Class 9.NOTE 3: The considered particle sizes (lower threshold values) applicable for classification in accordance with this part of ISO 14644 are limited to the range from 0, 1 µm through 5 µm. Air cleanliness may be described and specified (but not classified) in terms of U descriptors or M descriptors for considered threshold particle sizes that are outside of the range covered by classification.NOTE 4: Intermediate ISO classification numbers may be specified, with 0, 1 the smallest permitted increment; i.e. the range of intermediate ISO classes extends from ISO Class 1,1 through ISO Class 8,9.NOTE 5: Classification may be specified or accomplished in any of three occupancy states.ISO 14644-1.NOTE 6: Adapted from ISO 14644-1: 1999, 2.1.4

An area with airborne viable and non-viable particle contamination controlled within preset limits. A cleanroom designated by ISO Standard 14644-1 volume units (“In Operation”) or European Community (EC) Grades A, B, C, D (“At Rest” and “In Operation”). For pharmaceutical manufacture, a classified space implies ongoing environmental monitoring.

Free of dirt, residues, detergents, or any contaminants that may affect or adulterate the product or process.

Stand-alone equipment for treating and distributing clean air to achieve defined environmental conditions. ISO 14644-4.

Fan and filter unit used to locally clean room air and deliver it to a desired location. Often called a fan/filter unit.

An area where particulate and microbial levels are specified (e.g., Filling Room – Class 10,000 In operation).

An area where particulate and microbial levels are specified (e.g, Filling Room – Grade 7 or EU Grade B).

Internally cleaning a piece of equipment without relocation or disassembly. The equipment is cleaned but not necessarily sterilized. The cleaning is normally done by acid, caustic, or a combination of both, with water-for-injection (WFI) rinse.

A room in which the concentration of airborne particle is controlled to specified limits.

A room or volume controlled to meet a certain airborne particulate limit (Class or Grade). In pharmaceutical facilities, clean spaces are usually classified and controlled only for aseptic processing facilities, but may also be defined for certain biotech processes. Final non-sterile bulk facilities, oral product, most topical product manufacturing facilities, and warehouses are normally not classified as clean spaces.