CLIMACELL with Photostability

CLIMACELL with Photostability

Lab Equipment> Stability Chamber> Stability Chamber

광안정성시험챔버

제품설명

• 의약품 등의 원료, 완제품, 포장상태의 광안정성 시험에 사용
• ICH guidelines Q1A/Q1B option2와 European norm에 적합
• 광 트레이(VIS/UV)장착시 광챔버로 사용(Option, 광 트레이 탈착가능)
• 발열이 거의 없는 LED 광 트레이(VIS) 장착가능(Option, only EVO)
• 광 트레이 및 Flexible 광센서가 탈착이 가능하여 광안정성 시험 후 일반 안정성챔버로 활용가능
• Warmcomm Software를 통한 광 노출 그래프 및 평균 노출량을 계산해서 표시(Option)
• 10~100%의 광량 조절이 가능
• 내부 Stainless steel No.1.4301(AISI 304) 재질 사용
• 시험조건 및 사용목적에 따라 다양하게 용량과 옵션을 선택가능
• Climacell : 온도, 습도, VIS, UV 조건 설정가능
• Climacell EVO : 온도, 습도, VIS, UV, CO2 조건 설정가능(707, 1212ℓ 제외)
• 용량 : 111, 222, 404, 707, 1212ℓ
• 사용온도 : 099.9℃, 1090.0℃(습도 조절 시)
• 습도범위 : 10~90%
• Maker : MMM / GERMANY

연락처

경기본사 : 031-790-1907 (내선2)
대전지사 : 042-824-5167

CATALOGUE #1 DOWNLOAD

특징

ICH Guidenline

A. Light sources
The light source described below may be used for photostability testing.
The applicant should either maintain an appropriate control of temperature to minimize the effect of localized temperature changes or include a dark control in the same enviroment unless otherwise justified. For both options 1 and 2, a pharmaceutical manufacturer/applicant may rely on the spectral distribution specification of the light source manufacturer.
Option 2
For option2 the same sample should be exposed to both the cool white fluorescent and near ultraviolet lamp.
1. A cool white fluorescent lamp designed to
produce an output similar to that specified in
ISO 10977(1993) : and
2. A near UV Fluorescent lamp having a spectral distribution from 320nm to 400nm with a maximum energy emission between 350nm and 370nm ` a significant proportion of UV should be in both band of 320 to 360nm and 360 to 400nm

B. Procedure
For confirmatory studies, samples should be exposed to light prviding an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than
200 watt hours/square meter to allow direct comparisons to be made between the drug substance and drug product.

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