Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods

洁净室和相关控制环境 -
生物污染控制 -
第1部分：一般原则和方法

以下摘录第三章节 术语及定义：

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

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

3.1.13
impact sampler
device designed to sample particles in the air, or other gas, through a collision with a solid surface
3.1.14
impingement sampler
device designed to sample particles in the air, or other gas, through a collision with a liquid surface and the
subsequent entering into the liquid

3.1.15
qualification
process of demonstrating whether an entity — activity or process, product, organization, or any combination
thereof — is capable of fulfilling specified requirements
3.1.16
risk
combination of the probability of occurrence of harm and the severity of that harm

3.1.17
risk zone
defined and delimited space where individuals, products or materials (or any combination of these) are
particularly vulnerable to contamination
3.1.18
settle plate
suitable container (e.g. a Petri dish) of appropriate size, containing an appropriate, sterile, culture medium,
which is left open for a defined period to collect viable particles depositing from the air
3.1.19
swab
sterile collection device, non-toxic and non-inhibitory to the growth of the microorganisms being sampled,
consisting of a specific matrix of suitable size, mounted on an applicator
3.1.20
target level
defined level set by the user as a goal for routine operations, for the user's own purpose
3.1.21
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or
application have been fulfilled

verification
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

3.1.23
viable particle
particle that consists of, or supports, one or more live microorganisms
3.1.24
viable unit
VU
one or more viable particles which are enumerated as a single unit

3.2 Occupancy states
3.2.1
as-built
condition where the installation is complete with all services connected and functioning, but with no production
equipment, materials or personnel present

3.2.2
at-rest
condition where the installation is complete with equipment installed and operating in a manner agreed upon
by the customer and supplier, but with no personnel present

3.2.3
operational
condition where the installation is functioning in the specified manner, with the specified number of personnel
present and working in the manner agreed upon