|Accuracy||/- 0.5 oC|
|Uniformity||/- 1.0 oC|
|Temperature Display||HMI Touch screen 4.3inch with Colour display|
|Observation window||300 x 300 mm|
|Temperature Range (Degree Celsius)||10.0 oC to 60.0 oC|
The Purpose of Walk in incubator 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 incubator 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.
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
· 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
DATA RECORD :-
· 21 CFR Part 11 compliant software with audit trial ( who did what and when is recorded)
· Multilevel Passwords.