JB/T 20105-2022 in English
VALIDFriability tester
- Issued on:-
- Implemented on:-
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$204.00
本文件规定了脆碎度检查仪的分类和型号、要求、环境试验方法、检验规则、标志、使用说明书、包装、运输和贮存。
本文件适用于利用机械能检测片剂物理性能的脆碎度检查仪。
Introduction
Standard Revision Background and Technology Evolution
JB/T 20105-2022, as an important standard for the pharmaceutical machinery industry, has undergone its first major revision 15 years after replacing the 2007 version. This revision mainly responds to the development trend of Pharmaceutical Industry 4.0, focusing on strengthening the digital control capabilities and environmental adaptability requirements of Fragility Tester.
Definition of core terms
| Terms | Definition | Significance of test |
|---|---|---|
| Friability | Percentage of weight loss after tablets are rolled in the drum 100 times | Important indicator for evaluating the mechanical strength of tablets |
| Drum specifications | Diameter 286±2mm, depth 39±1mm | Key parameters to ensure comparability of test results |
Instrument classification and model compilation
The new standard will>Fragility tester is divided into two types according to its structure: single-drum and multi-drum. It is divided into two types according to speed control: fixed speed (25r/min) and adjustable speed (20-70r/min). Model compilation example:
- JCKT2 type: indicates a dual-drum adjustable speed instrument
- JCE type: indicates a single-drum fixed speed instrument
Comparison of key technical requirements
| Indicators | 2007 version | 2022 version | Description of changes |
|---|---|---|---|
| Speed accuracy | ±2r/min | ±1r/min | Accuracy improved by 100% |
| Counting error | Not specified | ≤±1r | New digital requirements |
| Software functions | No requirements | Required to have data record printing | Adapt to GMP traceability requirements |
Implementation suggestions
- Equipment selection: Prioritize models with adjustable speed function to adapt to the testing requirements of different dosage forms
- Verification points: Focus on verifying the counting accuracy of clause 5.3.3 and the data traceability function of 5.2.1(c)
- Maintenance cycle: It is recommended to calibrate the drum speed with a 1.0-level tachometer every 6 months
Environmental adaptability requirements
The standard stipulates that the instrument must pass the climate environment group II (temperature -20℃~55℃, humidity ≤93%RH) and mechanical environment group II tests. For specific test conditions, please refer to Chapter 6 of the standard. Pharmaceutical companies need to pay special attention to laboratory environmental humidity control to avoid affecting electrical safety performance.
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