GB/T 25916.2-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data
1 Scope
This part of GB/T 25916 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It shall be used, where appropriate, in conjunction with the Part 1 of this standard.
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 25916.1-2010 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1: 2003, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
action level
microbiological level set by the user in the context of controlled environments, which, when exceeded, requires immediate intervention, including investigation of cause, and corrective action
3.2
alert level
microbiological level set by the user for controlled environments, giving early warning of a potential drift from normal conditions
Note: When alert levels are exceeded, this should result in increased attention to the process.
3.3
audit trail
chain of related documents, or entries within records, that allows related information to be traced
3.4
biocontamination
contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles
3.5
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, 2.1.1][2]
3.6
data stratification
regrouping of data so that important trends and deviations can be more easily seen and understood
3.7
estimate
value of an estimator obtained as a result of an estimation
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Evaluation and interpretation of biocontamination data
Bibliography
