激光法-在線頂空氣體分析設(shè)備
SPECTRA HSA 300頂空氧氣分析儀是一種用于監(jiān)測(cè)密封注射容器內(nèi)頂空氧氣濃度的無(wú)損氣體分析在線設(shè)備。
這種小巧的臺(tái)式分析儀運(yùn)用獲得的激光吸收技術(shù)。近紅外激光產(chǎn)生的光線被調(diào)整至與氧分子的內(nèi)部吸收頻率相匹配，
并穿過產(chǎn)品上方頂空區(qū)域內(nèi)的容器。被吸收的激光量與頂空中的氧氣濃度成比例。采用這種無(wú)損測(cè)定方法可快速而全面地分析產(chǎn)品。
FDA 推薦、符合 USP1207。
應(yīng)用：
● 快速無(wú)損的殘氧分析
● 檢漏（針對(duì)充氮包裝間接性檢漏）
● 容器密閉完整性研究
● 灌裝線上吹掃系統(tǒng)的優(yōu)化和驗(yàn)證
● 氧濃度衰減研究
● 產(chǎn)品穩(wěn)定性和貨架期研究
SPECTRA HSX 300
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 SPECTRA HSX platform impresses with its highly sensitive laser system
ａnd the flexibility to be configured for individual requirements.
Features
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
