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SPECTRA HSX 300顶空氧气分析仪是一种用于监测密封注射容器内顶空氧气浓度的无损气体分析在线设备。
这种小巧的台式分析仪运用获得的激光吸收技术。近红外激光产生的光线被调整至与氧分子的内部吸收频率相匹配,
并穿过产品上方顶空区域内的容器。被吸收的激光量与顶空中的氧气浓度成比例。采用这种无损测定方法可快速而全面地分析产品。
FDA 推荐、符合 USP1207。
应用:
● 快速无损的残氧分析
● 检漏(针对充氮包装间接性检漏)
● 容器密闭完整性研究
● 灌装线上吹扫系统的优化和验证
● 氧浓度衰减研究
● 产品稳定性和货架期研究
The verification of quality relevant attributes of the headspace conditions e.g. in
lyophilized and liquid filled vials, requires non-destructive and robust inspection
technologies. The PK-HGA platform impresses with its highly sensitive laser system
and the flexibility to be configured for individual requirements.
Throughput up to 300 pcs/min
2ml up to 100 ml containers
Non-destructive head space analysis of vials, syringes, ampoules
Deterministic CCIT method preferred acc. USP<1207>
Applicable for glass and plastic containers
Simple format changeover
Design according GMP guidelines
Data Handling in compliance with 21 CFR part 11
Reliable product handling
Toolless format changeover
Optional integration of visual inspection systems
Optional integration of 2D DataMatrix Code reader
Optional integration of NIR Module for residual moisture and lyo defects