Walk in Incubator Standard / GMP Model
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.
- Temperature Range 10.0 °C to 60.0 °C. Accuracy +/- 0.5 °C. Uniformity +/- 1.0 °C
- Temperature Display : HMI Touch screen 4.3” with Colour display .
- 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.
- Observation window – 300 x 300 mm
- Stainless steel Trays
- Double walled , gap between walls filled with PUF Insulation.
- Double walled with 80 mm insulated modular with panels with easy on-site assembly
- Standard Model : Stainless steel Mirror polished chamber and heavy guage Powder- coated CRC exterior.
- 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.
- 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
- Over heat temperature and humidity cut off with alarm.
- Low temperature alarm.
- Electrical overload compressor cutoff.
- Time delay for compressor switch on.
- Electrical short circuit breaker.
- Room temperature around machine preferably at 25 degree C.
- Stabilised input voltage of 230V Ac, 50 Hz,
- Water drain line with ½” Nozzle to be provided at floor level.
- 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 synchronisation.
|MODEL NO.||CAPACITY||DIMENSION IN CMS||TRAY QTY||TRAY SIZE in mm|
|Standard||GMP||Cu. Ft||Litres||Chamber size in mtr (HxWxD)||Over All size in mtr (HxWxD)|
|HAMCO64S -230||HAMCO64 G-230||230||6400||2.41.362.0||2.561.522.16||32||870X300|
|HAMCO64S -280||HAMCO64 G-280||280||8000||2.02.0×2.0||22.214.171.124||24||870X600|
|HAMCO64S -340||HAMCO64 G-340||340||9600||2.42.0×2.0||2.562.162.16||32||870X600|
|HAMCO64S -428||HAMCO64 G-428||428||12000||2.42.0×2.5||2.562.162.66||48||725X600|
|HAMCO64S -530||HAMCO64 G-530||530||15000||126.96.36.199||2.562.662.66||48||725X800|
|HAMCO64S -640||HAMCO64 G-640||640||18000||188.8.131.52||2.562.663.16||48||900X800|