針對EN標準、FDA、GMP、ICH指導原則中規定的穩定性試驗（ICH QIA R2）和光穩定性試驗（ICH Q1B OPTION2）標準要求，FITOCLIMA 600 PH / PLH穩定性試驗箱分別提供完善的解決方案，以滿足嚴格的要求。

註: ICH guidelines Q1B OPTION 2要求：在確認研究中，樣品應暴露在總照度不低於1.2*106lux.hr，近紫外能量不低於200W.Hr/m2，直接在藥物和製劑之間進行比較。

原廠網站:

大容量藥品光安定性試驗箱 Q1B 600L

檔案下載:

Aralab 藥品穩定性試驗箱目錄
Aralab-STABILITY-FitoClima-600-1200 testing hambers brochure 2020.pdf

影片連結:

• Environmental Stability chambers for storage and testing according to ICH guidelines with unsurpassed stability and uniformity of climatic conditions.
• Performs ICH Q1B guidelines tests for photostability in less than 50 hours, with tracking of accumulated UV and Visible light emission and automatic stop function.
• Controller and software compliant with FDA 21 CFR part 11 guidelines for data logging. Qualifications IQ, OQ and PQ provided for required quality on-site validations.
• ICH Q1B compliant and recognized by other leading industry standards (FDA, EMA, WHO, GLP)