Hi-Tech make Walk in Chamber are designed for simulating monitoring & control of environmental conditions with temperature & humidity. The purpose of walk in stability testing is to provide evidence on the how the quality of drug substances or drug product varies with time under the influence of environmental factors such as temperature, humidity and light and to establish a re test period for the drug substance or product under recommended storage conditions. Hence stability chamber serves as an important quality attribute of the product.

HiTech make GMP walk in stability test chambers are especially built to pass FDA and ICH Q1A compliance standards and have a reputation for reliability, quality and performance. Exceed FDA/ICH guidelines for long term, intermediate and accelerated stability studies.

Specifications

•  Temperature range 20.0 °c to 60.0 °c. Accuracy +/- 0.2 °c. Uniformity +/- 1.0 °c
•  Humidity range: 40% to 95% rh, accuracy +/- 3% Rh, uniformity +/- 3% rh.

Construction

•  Double walled, gap between walls filled with Puf insulation.
•  GMP model: stainless steel mirror polished chamber and exterior of dull finish stainless steel.
•  Stainless steel trays. Adjustable tray height adjustment.
•  HMI touch screen controller of 4.3”/ 7” with data logging facility.
•  21 CFR part 11 compliant software with audit trial
•  Data storage device has online and offline capabilities.