ISO 13408-2:2018 ヘルスケア製品の無菌処理—パート2：滅菌ろ過 | ページ 6

3.1

bacterial challenge test

technical operation performed to evaluate the capability of a filter (3.5) to retain organisms from liquid bacterial suspension under defined conditions

3.2

bioburden

population of viable microorganisms (3.9) on or in product and/or sterile barrier system

Note 1 to entry: For the purposes of this document, the definition of bioburden is the population of viable microorganisms in a fluid (3.6) prior to sterilizing filtration (3.11) .

3.3

chemical compatibility

<filter> capability of process fluids (3.6) and filter (3.5) materials to be used together, under the specified process conditions, without adverse effects on either the fluids or filter materials

3.4

extractable

substance that can be released from a filter (3.5) or material using extraction solvents and/or extraction conditions that are expected to be at least as aggressive as the normal use conditions

[SOURCE:ISO 10993‑12:2012, 3.8, modified — The wording has been modified.]

3.5

filter

construct of porous material through which a fluid (3.6) is passed to remove viable and/or non-viable particles

3.6

fluid

substance that continually deforms (flows) under applied shear force

Note 1 to entry: The filtrate of the fluid subjected to the sterilizing filtration (3.11) process might be the product to be produced, a part of the formulation, a gas used to provide overpressure or a process gas released into the aseptic processing area (e.g. gases released from air actuated valves).

3.7

filter integrity test

non-destructive physical test that can be correlated to the bacterial retention capability of a filter assembly

3.8

leachable

substance that can be released from a filter (3.5) or filter assembly during normal use conditions

3.9

microorganism

entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses

Note 1 to entry: Viruses are not addressed in this document.

3.10

pore size rating

nominal pore size of a filter (3.5) as claimed and stated in the labelling

Note 1 to entry: The pore size rating is determined by retention performance with a model particle. The pore size rating is not necessarily the physical diameter of the pores but is a rating based on the size of particles which might not pass through the filter.

3.11

sterilizing filtration

removal of viable microorganisms (3.9) from fluids (3.6) by passage of the fluid through a filter (3.5) under specified process conditions resulting in a sterile filtrate