SN/T 1538.1-2016 in English
VALIDGuidelines on preparation and production of culture media-Part 1:General guidelines on quality assurance for the preparation of culture media in the laboratory
- Issued on:2016-08-23
- Implemented on:2017-03-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$369.00
Introduction
Analysis of the core content of the standard
| Technical elements | 2005 edition | Main changes in the 2016 edition |
|---|---|---|
| Scope of application | Basic laboratory requirements | Expanded to three types of culture media: commercial ready-to-use, dehydrated synthetic and component prepared |
| Definition of terms | 23 items | 9 new definitions such as transport/preservation/suspension culture media, totaling 32 items |
| Quality control strain management | Secondary management system | Establish a three-level system of standard strain → reserve strain → working strain |
Detailed explanation of key technical requirements
1. Culture medium classification system
The standard divides culture media into liquid culture media, semi-solid culture media and solid culture media according to their physical state. The agar content of solid culture media must be controlled at 1.2-1.5%.
- Selective culture medium: such as XLD agar, the bile salt inhibition amplitude should be more than 85%
- Identification culture medium: the lactose fermentation reaction of MacConkey agar needs to develop color within 18-24h
- Complex functional culture medium: such as blood agar, which has both recovery and identification characteristics
2. Key points of quality control in the preparation process
Key parameter control table
| Link | Control index | Allow deviation |
|---|---|---|
| Rehydration | Conductivity | ≤25 μS/cm(25℃) |
| Sterilization | Temperature/time | 121±1℃/15min |
| pH adjustment | Difference before and after sterilization | ±0.2 unit |
Typical case: After boiling, the intestinal bacteria culture medium needs to be quickly cooled to below 50℃ to avoid bile salt decomposition
Recommendations for the implementation of the standard
- Establish a culture medium batch number traceability system, and record the receipt date, opening time and sensory inspection results
- Implement repackaging and freezing management for heat-sensitive additives (such as antibiotics), and the shelf life after thawing shall not exceed 7 days
- Adopt the three-level strain preservation method: standard strain (lyophilized) → reserve strain (-70℃) → working strain (4℃)
Technology evolution analysis
The main differences between this standard and ISO TS 11133-1:2009 are:
- Added the special requirements for water quality testing of Chinese Pharmacopoeia
- Strengthened the acceptance clauses for commercial ready-to-use culture media
- The troubleshooting provided in Appendix B is unique content

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