PDA Technical Glossary

The total number of microorganisms per unit of material prior to sterilization. (TR13) Total number of viable microorganisms on or in a health care product prior to sterilization. (TR22)(TR61)(TR62) A population of viable microorganisms in a fluid prior to sterilizing filtration. (TR26) A measure of the contaminating organisms found in or on a given amount of material before it undergoes a sterilization process. (TR45) (TR70) The number of detectable microorganisms (bacteria and fungi) with which an object is contaminated. It is measured in CFU (colony forming units). (TR47) The number of viable, contaminating microorganisms present on a product immediately prior to decontamination. (TR51) Viable microbial contaminants associated with personnel manufacturing environments (air and surfaces), equipment, product packaging, raw materials (including water), in-process materials, and finished products. (TR 67) (TR 69)

Compact, self-contained filter assembly. Generally, the whole assembly is disposable. (TR26) (TR41)

Filter elements encased in a housing. Generally, the filter elements are disposable while the housing units are multi-use. In a few cases, both filter and housings are disposable. (TR26) (TR41)

Proof that no adverse interaction between the filter and the process fluid has occurred. (TR26) A term used in relation to the non-reactivity of filter materials with the substance to be filtered. (TR45)

A chemical component that is removed from a material by application of an artificial or exaggerated force (e.g., solvent, temperature, time). The term extractable is often erroneously used to describe a leachable. (TR14) (TR15) (TR26) (TR41) (TR45) Chemical substances that can be extracted from components of material process fluid contact surfaces by exertion of an exaggerated force (e.g., organic solvent, extreme elevated temperature, ionic strength, pH, contact time, etc.) Extractables may represent most but not all of the potential leachables that may be seen in process fluids. (TR66) Extractables are organic and inorganic chemical entities that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions. (TR54-4) Organic or inorganic chemical entity that is forced out of container closure system materials and components under laboratory experimental conditions. (TR73)

The process by which a material is rendered sterile by exposing the material to a radioactive source, such as Cobalt 60. (TR70) Ionizing radiation that can be used to sterilize a material. (TR26)

Test to determine the functional performance of a membrane filter or container/closure system. (TR22) A nondestructive test used to predict the functional performance of a filter. (TR45) A nondestructive physical test that can be correlated to the bacterial retention capability of a filter/filter assembly. (TR26)

A chemical component that migrates from a contact surface into a drug product or process fluid during storage or normal use conditions. The term leachable is often erroneously used to describe an extractable. (TR14) (TR26) Leachables are organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables. (TR54-4) Chemical substances that are leached, from product-contact or non-product-contact materials, under typical process conditions and detected in final dosage. Leachables may be a subset of extractables, and can include their reaction or breakdown products. (TR66) Organic or inorganic chemical entity that migrates from pharmaceutical container closure system components into a drug product formulation. (TR73)

An analytical test method for identifying the chemical composition of a sample by separating its gaseous component ions according to their mass and charge. (TR26)

A microbe; a free-living organism too small to be seen by the naked eye. (TR45) (TR26)

Refers to a filter that does not shed fibers into the filtrate. (TR26)

Any discrete unit of material structure; a discernible mass having an observable length, width, thickness, size and shape. (TR45) (TR26) Foreign material which is unintended and either removable from the surface of a primary packaging component or freely moving within a filled and sealed pharmaceutical dosage form. The term particle is used interchangeably with “particulate” and “particulate matter” without any intended difference in meaning. (TR85)

Relating to, or occurring in the form of particles. (TR45) (TR26)

Any filter placed upstream of the final filter. (TR26)

A type of serial filtration in which a second sterilizing-grade filter is used as a backup in the event of an integrity failure of the primary sterilizing filter. (TR26)

Filtration through two or more filters of the same or decreasing pore size, one after the other. (TR26)

The influent side of the filter. (TR45) (TR26)