Come Selezionare la Glassine per Applicazioni di Etichettatura Medica
Creato il 09.01
选择适合医疗标签应用的玻璃纸是一个关键过程，它平衡了材料性能、法规合规性和制造效率。以下是关于如何做出正确选择的全面指南。
Executive Summary: 为什么选择玻璃纸
Glassine是一种光滑、光泽且具有防空气特性的超压光纸。它在医疗标签上的主要优点是：
- High Purity & Inertness: Chemically neutral, it doesn't interact with medications or medical devices.
- Excellent Die-Cutting: Cuts cleanly without dusting, crucial for complex label shapes.
- Moisture & Grease Resistance: 自然抵抗油脂，保护粘合剂。
- Deadfold & Stability: 保持折痕并平放，这对于涂抹到注射器、瓶子和设备上非常重要。
- Printability: 提供高质量印刷和可变信息的优良表面。
Step-by-Step Selection Criteria
1. 监管和合规要求（首要任务）
This is non-negotiable. The material must meet stringent standards.
- FDA 21 CFR Part 175.105 / 175.125: 这证明了粘合剂和面料适合间接接触食品，这是制药包装的一个常见基准。确保您的供应商提供这些法规的 保证函 (LOG) 或 合规声明。
- USP <661> / USP <661.1> (美国药典)：这些章节规定了塑料包装系统及其构造材料的测试协议。虽然传统上针对塑料，但可提取物和浸出物的原则越来越多地应用于纸基材料，如玻璃纸。请与您的供应商确认他们的产品经过测试并符合这些要求的精神。
- REACH / RoHS: 确保材料不含高度关注物质（SVHC）和受限危险材料，这对欧盟市场尤为重要。
- Supplier Documentation: Your supplier must provide full traceability and Certificates of Analysis (CoA) for each batch to ensure consistency and compliance.
2. 功能性能属性
Evaluate the glassine based on the specific needs of the application.
- Basis Weight/Thickness:
Measured in 克每平方米 (gsm) 或 磅每令 (lbs).
Standard: 60-90 gsm is common.
Thinner (例如，60克/平方米)：提供高灵活性，适合小直径（例如，注射器筒），且具有成本效益。
更厚（例如，90克/平方米）：提供更强的刚性，在自动应用器中具有更好的“弹出”效果，并且手感更佳。更适合大型设备标签。
- Caliper (Thickness): Measured in mils or microns. A consistent caliper is crucial for smooth dispensing and die-cutting.
- Moisture Vapor Transmission Rate (MVTR):
While glassine is a good barrier, some high-potency drugs or sensitive devices may require an extra level of protection.
Ask your supplier for MVTR data. If a better barrier is needed, consider clay-coated glassine or a film-based liner (e.g., PET polyester).
- Lay Flat & Curl: The liner must lie perfectly flat on the roll to prevent jamming in high-speed printing and dispensing equipment. Humidity can affect this, so discuss environmental conditions with your supplier.
- Release Level: 这是从玻璃纸衬里剥离标签所需的力量。它由硅胶涂层控制。
Standard Release: The most common choice.
Low Release (Easy Release): Used for very aggressive permanent adhesives or very fragile labels to prevent tearing or "flagging."
高释放（紧密释放）：用于较不强力的粘合剂，以确保标签在转换和运输过程中不会从衬纸上脱落。
Your label converter will help specify the correct release level.
3. 转换和打印注意事项
如何在标签制造过程中材料会表现如何？
- Die-Cutting Performance: This is a key strength of glassine. It must die-cut cleanly (to allow for easy matrix stripping) without fracturing or "nickering," which creates paper dust that can contaminate sterile environments.
- Printability:
Surface Energy: Should be >38 dynes/cm to ensure good ink adhesion. Most quality glassine liners are treated to meet this.
Porosidad: Afecta la absorción de tinta y el tiempo de secado. Discuta con su impresora para hacer coincidir el sistema de tinta (por ejemplo, flexo UV, a base de agua).
- Matrix Removal: The "waste" material around the labels must strip away cleanly and reliably at high speeds without breaking.
4. 最终用途应用环境
最终标签将应用于哪里并存储？
- Temperature Extremes: Will the labeled product be autoclaved, frozen (e.g., -80°C storage), or exposed to high heat? Ensure the adhesive is matched to this, and confirm the glassine's performance won't degrade (e.g., become brittle when frozen).
- 化学暴露：标签是否会暴露于酒精棉球、溶剂或消毒剂（例如，VHP、ETO、伽马辐射）？虽然标签面料和粘合剂是主要的屏障，但衬纸在应用过程中不得降解或变得难以去除。
- Application Method:
- Manual Application: Less critical for liner performance.
- High-Speed Automated Application: The liner must have consistent caliper and roll geometry to run smoothly on automatic label applicators (ALAs). It must also release the label predictably and cleanly.
Common Types of Glassine for Medical Use
Type | 描述 | Best For |
Standard Glassine | The most common type, natural white, super-calendered. | 通用药品标签，瓶标签，设备标签。 |
Clay-Coated Glassine | Has a thin coating of clay on the surface, creating an even smoother, more impermeable barrier. | 更高的屏障要求，卓越的印刷质量和墨水保持性。 |
PEGylated (Polycoated) Glassine | 涂覆聚乙烯（PEG）层。提供显著更高的湿气和化学屏障。 | Applications requiring the best possible barrier in a paper-based liner, often used for freezer-grade labels. |
Thermal Glassine | A specific grade designed to withstand the heat of thermal transfer printers without releasing gases that can clog print heads. | Labels that require variable information (barcodes, serialization) printed via thermal transfer. |
决策流程图
1. 定义合规需求：必须符合FDA CFR 21和USP。→ 获取供应商LOG/CoA。
2. 评估障碍要求：
Standard moisture/grease resistance? → 标准玻璃纸。
Enhanced barrier for sensitive drugs? → Clay-Coated or PEGylated Glassine.
Extreme barrier or chemical exposure? → Consider a Film Liner (PET).
3. 确定申请方法：
High-speed automated application? → Prioritize consistent caliper and lay-flat
Manual application? → Focus on cost and ease of use.
4. 考虑打印：
Printing variable data with thermal transfer? → Specify Thermal Glassine.
High-quality graphics? → Clay-Coated Glassine offers superior printability.
5. 原型和测试：这是最关键的一步。与您的标签转换器合作进行试验。测试：
Die-cutting on your specific label shape.
Dispensing on your automatic applicators.
Label application and adhesion under real-world conditions (sterilization, freezing, etc.).
Partner with Experts
最终，选择合适的玻璃纸的最佳方法是与两个实体密切合作：
1. 您的标签转换器：他们拥有技术专长，可以根据您的印刷、模切和应用设备推荐材料。
2. 纸张制造商（例如，Xianhe、Heming、Mondi、Sappi、Expera、Nordic Paper）：他们可以提供技术数据表、合规文件和基于最终使用环境的建议。
By systematically evaluating these factors—starting with compliance and moving through functionality, conversion, and application—you can reliably select the optimal glassine liner for your medical label application.
Ray
Ferrill
Evelyn