This standard specifies the basic principles, general requirements and examination methods for determination of functional microorganism in biologic products.
This standard is applicable to examination of lactobacillus plantarum, lactobacillus acidophilus, bacillus subtilis, bacillus licheniformis, enterococcus faecalis, enterococcus faecium, candida utilis and saccharomyces cerevisiae.
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 of the referenced document (including any amendments) applies.
GB 4789.1 National food safety standard - Food microbiological examination - General guidelines
GB 4789.28 National food safety standard - Food microbiological examination - Quality requirements for medium and reagents
GB 19489 Laboratories - General requirements for biosafety
GB/T 27405 Criterion on quality control of laboratories - Microbiological testing of food
RB/T 151 Guidelines for the estimation of measurement uncertainty of food microbiological quantitative detection
SN/T 0330 General rules for microbiological examinations of export food
SN/T 2632 Technical codes for routine microbial culture collection
SN/T 2660 Preservation methods for culture collection in foodstuff microbiology laboratory
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
biologic products
industrial products related to biology
Note: the biologic products in this standard refer in particular to the viable bacteria preparations produced by the functional microorganisms after industrial production and propagation, and the products with such preparations.
3.2
functional microorganism
viable microbial strains with precise regulation and improvement functions under certain conditions
3.3
colony-forming units; CFU
colony formed by growth and propagation of single thalli or gathered thallus on solid medium during culture and counting of viable bacteria
4 General
4.1 The examination of functional microorganism implemented in accordance with this standard shall comply with the requirements of SN/T 0330.
4.2 Biosafety requirements for laboratories shall meet the requirements of GB 19489.
4.3 The laboratory personnel shall meet the requirements of GB 4789.1.
4.4 Strain preservation shall meet the requirements of SN/T 2632 and SN/T 2660.
4.5 The quality requirements for culture media and reagents shall meet the requirements of GB 4789.28.
4.6 The laboratory quality control shall meet the requirements of GB/T 27405.
4.7 The quantitative determination value is rounded off and reported in unit of CFU/g/(CFU/mL). The estimation of measurement uncertainty of quantitative determinations is performed in accordance with the requirements of RB/T 151.
GB/T 34224-2017 The following standards are cited：
