GB/T 25916.1-2010 Cleanrooms and associated controlled environments - Biocontamination Control - Part 1: General principles and methods
1 Scope
This part of GB/T 25916 establishes the principles and basic methodology of a formal system of biocontamination control for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. This part specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used as a source of information.
Application-specific requirements are not given. Neither are fire and safety issues addressed; for these, see regulatory requirements and other national or local documentation.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 25915.4-2010 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4: 2001, IDT)
GB/T 25916.2-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2: 2003, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
action level
level set by the user in the context of controlled environments, which, when exceeded, requires immediate intervention, including investigation of cause, and corrective action
3.1.2
alert level
level set by the user in the context of controlled environments, giving early warning of a drift from normal conditions, which, when exceeded, should result in increased attention to the process
3.1.3
bioaerosol
dispersed biological agents in a gaseous environment
3.1.4
biocontamination
contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles
3.1.5
cleanroom
room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity and pressure, are controlled as necessary
[GB/T 25915.1-2010, Definition 2.1.1] [2]
3.1.6
contact device
specially designed appliance holding an appropriate, sterile, culture medium with an accessible surface used for surface sampling
3.1.7
contact plate
contact device where the container is a rigid dish
3.1.8
control point
point in a controlled environment at which control is applied and a hazard can be prevented, eliminated or reduced to acceptable levels
3.1.9
controlled environment
defined zone in which sources of contamination are controlled by specified means
3.1.10
corrective action
action to be taken when the results of monitoring indicate that alert or action levels are exceeded
3.1.11
formal system
system of biocontamination control with established and documented procedures
3.1.12
hazard
potential source of harm
Foreword i Introduction ii 1 Scope 2 Normative references 3 Terms and definitions 4 Principles of biocontamination control 5 Establishing the formal system 6 Expression, interpretation and reporting of results 7 Verification of the formal system 8 Training 9 Documentation Annex A (Informative) Guidance on determining airborne biocontamination Annex B (Informative) Guidance on validating air samplers Annex C (Informative) Guidance on determining biocontamination of surfaces Annex D (Informative) Guidance on determining biocontamination of textiles Annex E (Informative) Guidance on validating laundering processes Annex F (Informative) Guidance on determining biocontamination of liquids Annex G (Informative) Guidance on training Bibliography
GB/T 25916.1-2010 Cleanrooms and associated controlled environments - Biocontamination Control - Part 1: General principles and methods
1 Scope
This part of GB/T 25916 establishes the principles and basic methodology of a formal system of biocontamination control for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. This part specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used as a source of information.
Application-specific requirements are not given. Neither are fire and safety issues addressed; for these, see regulatory requirements and other national or local documentation.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 25915.4-2010 Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4: 2001, IDT)
GB/T 25916.2-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2: 2003, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
action level
level set by the user in the context of controlled environments, which, when exceeded, requires immediate intervention, including investigation of cause, and corrective action
3.1.2
alert level
level set by the user in the context of controlled environments, giving early warning of a drift from normal conditions, which, when exceeded, should result in increased attention to the process
3.1.3
bioaerosol
dispersed biological agents in a gaseous environment
3.1.4
biocontamination
contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles
3.1.5
cleanroom
room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity and pressure, are controlled as necessary
[GB/T 25915.1-2010, Definition 2.1.1] [2]
3.1.6
contact device
specially designed appliance holding an appropriate, sterile, culture medium with an accessible surface used for surface sampling
3.1.7
contact plate
contact device where the container is a rigid dish
3.1.8
control point
point in a controlled environment at which control is applied and a hazard can be prevented, eliminated or reduced to acceptable levels
3.1.9
controlled environment
defined zone in which sources of contamination are controlled by specified means
3.1.10
corrective action
action to be taken when the results of monitoring indicate that alert or action levels are exceeded
3.1.11
formal system
system of biocontamination control with established and documented procedures
3.1.12
hazard
potential source of harm
Contents of GB/T 25916.1-2010
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Principles of biocontamination control
5 Establishing the formal system
6 Expression, interpretation and reporting of results
7 Verification of the formal system
8 Training
9 Documentation
Annex A (Informative) Guidance on determining airborne biocontamination
Annex B (Informative) Guidance on validating air samplers
Annex C (Informative) Guidance on determining biocontamination of surfaces
Annex D (Informative) Guidance on determining biocontamination of textiles
Annex E (Informative) Guidance on validating laundering processes
Annex F (Informative) Guidance on determining biocontamination of liquids
Annex G (Informative) Guidance on training
Bibliography
