GB/T 35594-2023 in English
VALIDPaper and board for pharmaceutical packaging
- Issued on:2023-12-28
- Implemented on:2024-07-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$243.00
《GB/T 35594-2023医药包装用纸和纸板》由TC141（全国造纸工业标准化技术委员会）归口，主管部门为中国轻工业联合会。
Introduction
1. Standard background and revision notes
GB/T35594-2023 "Paper and paperboard for pharmaceutical packaging" replaces the old version GB/T35594-2017. The main revisions include:
- Indicator name optimization: For example, "quantitative" is changed to "quantitative deviation" to improve the accuracy of the expression.
- New technical requirements: Added test items such as decolorization performance and heavy metal content.
- Test method improvement: Supplemented the determination methods of microbial barrier properties and crease stiffness.
2. Comparison table of standard frameworks
| Dimensions | Old version requirements | New version requirements |
|---|---|---|
| Classification | Unclear classification | Divided into medical packaging paper and pharmaceutical packaging paperboard |
| Test indicators | Microbial barrier properties are not included | New requirements for microbial barrier properties |
| Test methods | Lack of appendix support | Supplement Appendix A and B to clarify the measurement method |
3. Technical requirements and performance indicators
3.1 Comparison of physical and chemical performance indicators
Medical packaging paper:Must meet the physical and chemical performance requirements in Table 1, including tear index, air permeability, tensile index, etc.
Drug packaging paperboard:Must meet the technical indicators in Table 2, such as transverse folding resistance and internal bonding strength.
3.2 Microbiological indicators
The standard requires that coliform bacteria, salmonella and mold (CFU/g) should not be detected in medical packaging paper and drug packaging paperboard. For specific detection methods, please refer to Table 3.
4. Implementation suggestions
- Enterprise level:It is recommended that manufacturers adjust their production processes according to the new version of the standard to ensure that the indicators meet the requirements.
- Testing institutions: Should be equipped with corresponding testing equipment, such as D65 brightness meter, microbial incubator, etc., to meet the needs of new testing items.
- User feedback: It is recommended to add the labeling of microbial barrier characteristics to the product label to facilitate the selection of downstream enterprises.
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