Stability Chamber

The Purpose of 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.

HAMCO Make GMP 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.

DATA RECORD :-

· 21 CFR Part 11 compliant software with audit trial ( who did what and when is recorded)

· Multilevel Passwords.

· Data storage device has online and offline capabilities.

· Multi chamber data acquisition on single software.

· Tabular and graphical report, alarm deviation report.

· Mean Kinetic temperature report and alarm deviation report.

· Audit trial report.

· Attractive reports and graphs.

· Alarm report.

· Time synchronization.

Walk In Stability Chamber

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Approx. Rs 2.5 Lakh / Piece

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Product Details:

Observation window300 x 300 mm
TraysStainless steel
Temperature Range20.0 oC to 60.0 oC.
Temperature Accuracy /- 0.2 oC
Temperature Uniformity /- 1.0 oC
Humidity range40% to 95% RH,
Humidity Accuracy /- 3% RH
Humidity Uniformity /- 3% RH.
Temperature & Humidity DisplayHMI Touch screen 4.3inch with Colour display

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.HAMCO 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.

 

Details:

· Heating system: U shaped Fin type Nichrome wire heater in SS Sheathing.

· Cooling system : Hermetically sealed CFC free Emerson compressor with R 134a refrigerant .

· System is made up of split type condenser unit in well-ventilated area to avoid throw of hot air in the room

· Non Condensing steam injection type humidity system with standby heater & auto switch overs.

· Stand by humidity system

· Air circulation : Flange Motor with Impeller and blower for Forced Air Circulation.

· Interior Illumination for working Area.

 

CONTROL PANEL :-

· HMI Touch screen controller of 4.3”/ 7” with data logging facility.

· Data logging of atleast 1000 data is possible.

· Real time Graph visualisation facility.

· Multiuser with password protection facility.

· High Speed Ethernet based communication.

· Audio/Visual alarm for deviation.

· All operations through a single 4.3”/7” colour Touch Screen.


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