ISO 13408-1:2008 ヘルスケア製品の無菌処理—パート1：一般要件 | ページ 6

3.1

action level

established microbial or particulate monitoring results requiring immediate follow-up and corrective action

3.2

airlock

room with interlocked doors designed to maintain pressure control between adjacent rooms of different cleanliness class

3.3

alert level

established microbial or particulate monitoring results giving early warning of potential drift from normal operating conditions which are not necessarily grounds for definitive corrective action but which could require follow-up investigation

3.4

aseptic processing

handling of sterile product, containers and/or devices in a controlled environment, in which the air supply, materials, equipment and personnel are regulated to maintain sterility

Note 1 to entry: This includes sterilization by membrane filtration which cannot be separated from the subsequent aseptic process.

3.5

aseptic processing area

APA

facilities for aseptic processing (3.4) , consisting of several zones

3.6

bioburden

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

[SOURCE: ISO/TS 11139:2006, definition 2.2]

Note 1 to entry: For the purposes of aseptic processing, the bioburden of concern is that on or in the product including all factors affecting it such as raw material, intermediates, other components and equipment.

3.7

bio-decontamination

removal of microbiological contamination or its reduction to an acceptable level

[SOURCE: ISO 13408-6:2005, definition 3.1]

3.8

cleaning

removal of contamination from an item to the extent necessary for further processing or for intended use

[SOURCE: ISO/TS 11139:2006, definition 2.7]

3.9

combination product

product comprised of drug/device, biologic/device, drug/biologic or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity

3.10

correction

action to eliminate a detected nonconformity

Note 1 to entry: A correction can be made in conjunction with a corrective action.

[SOURCE: ISO 9000:2005; definition 3.6.6]

3.11

corrective action

action to eliminate the cause of a detected nonconformity or other undesirable situation

[SOURCE: ISO 9000:2005, definition 3.6.5]

Note 1 to entry: There can be more than one cause for a nonconformity.

Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (3.29) is taken to prevent occurrence.

Note 3 to entry: There is a distinction between correction and corrective action.

Note 4 to entry: Corrective actions might be subject to change control.

3.12

critical processing zone

location within the aseptic processing area in which product and critical surfaces are exposed to the environment

3.13

critical surface

surface that may come into contact with or directly affect a product or its containers or closures

3.14

depyrogentation

validated process designed to remove or deactivate endotoxins

3.15

design qualification

verification that the proposed specification for the facility, equipment or system is suitable for the intended use

[SOURCE: ISO/TS 11139:2006, definition 2.12]

3.16

direct support zone

protective area directly surrounding a critical processing zone

3.17

disinfectant

chemical agent that is able to reduce the number of viable microorganisms

3.18

disinfection

removal, destruction or de-activation of microorganisms on objects or surfaces

[SOURCE: ISO 14644-5:2004;definition 3.1.4]

3.19

endotoxin

lipopolysaccharide component of the cell wall of Gram-negative bacteria which is heat stable and elicits a variety of inflammatory responses in animals and humans

3.20

environmental isolates

microorganisms present in and/or isolated from processing or manufacturing environments

3.21

gowning procedure

defined steps to reduce the risk of contamination while putting on the protective garments needed to enter the APA (3.5)

3.22

health care product

medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s)

[SOURCE: ISO/TS 11139:2006, definition 2.20]

3.23

high efficiency particulate air filter

HEPA filter

retentive matrix having a minimum particle-collection efficiency of 99,97 % (that is, a maximum particle penetration of 0,03 % for 0,3 µm particles)

3.24

indirect support zone

location within the aseptic processing area which protects the direct support zone

Note 1 to entry: The required grade of cleanliness of the indirect support zone depends on the aseptic processing activities performed in the indirect processing zone.

3.25

installation qualification

DEPRECATED: IQ

process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification

[SOURCE: ISO/TS 11139:2006, definition 2.22]

3.26

isolator

enclosure capable of preventing ingress of contaminants by means of physical interior/exterior separation, and capable of being subject to reproducible interior bio-decontamination

Note 1 to entry: An isolator can range in size from a small box to a large room.

3.27

operational qualification

OQ

process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures

[SOURCE: ISO/TS 11139:2006, definition 2.27]

3.28

performance qualification

PQ

process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification

[SOURCE: ISO/TS 11139:2006, definition 2.30]

3.29

preventive action

action to eliminate the cause of a potential nonconformity or other undesirable potential situation

[SOURCE: ISO 9000:2005, definition 3.6.4]

Note 1 to entry: There can be more than one cause for a potential nonconformity.

Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action (3.11) is taken to prevent recurrence.

3.30

qualification

documented process used by the health care product manufacturer to assure the reliability and capability of equipment and/or processes before approval for use in manufacturing

Note 1 to entry: Qualification of equipment and/or processes generally includes installation qualification (3.25) , operational qualification (3.27) and performance qualification (3.28) .

3.31

risk control

process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels

[SOURCE: ISO 14971:2007, definition 2.19]

3.32

separative device

equipment utilizing constructional and dynamic means to create assured levels of separation between the inside and outside of a defined volume

Note 1 to entry: Some industry-specific examples of separative devices are clean air hoods, containment enclosures, gloveboxes, isolators and mini-environments.

[SOURCE: ISO 14644-7:2004, definition 3.17]

3.33

shift

scheduled period of work or production staffed by a single defined group of workers

Note 1 to entry: This is usually not more than 12 h in length.

3.34

sterile

free from viable microorganisms

[SOURCE: ISO/TS 11139:2006, definition 2.43]

Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven, see sterilization (3.35) .

3.35

sterilization

validated process used to render a product free from viable microorganisms

[SOURCE: ISO/TS 11139:2006, definition 2.47]

3.36

terminal sterilization

process whereby product is sterilized within its sterile barrier system

[SOURCE: ISO/TS 11139:2006, definition 2.52]

3.37

ultra low penetration air filter

ULPA filter

matrix with minimum 0,3 µm particle retaining efficiency of 99,999 %

3.38

unidirectional airflow

air stream which has a defined direction

3.39

unit operation

defined chemical or physical step in a manufacturing process

Note 1 to entry: See example of a flowchart in Annex A.

3.40

validation

documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications

[SOURCE: ISO/TS 11139:2006, definition 2.55]

3.41

worst case

set of conditions that represent the greatest challenge to product integrity and safety which will be accepted during routine production