Seed Germinator Standard / GMP Model
The Purpose of Seed germinator 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 photo-stability chamber serves as an important Quality attribute of the product.
HAMCO Make GMP photo- stability test chambers are especially built to Pass FDA and ICH Q1B compliance standards and have a reputation for reliability, quality and performance. Exceed FDA/ICH guidelines for long term , intermediate and accelerated stability studies.
A state of the art Photo-stability chambers are available. This chamber has the capability to provide fluorescent light intensities from 1,000 to 10,000 Lux hour. Samples stored at 10,000 Lux can satisfy the ICH guidelines for light exposure in as little as five days. The UV study is done simultaneously. Separate switches are provided for incandescent & UV light sources.
- Temperature Range 5.0 °C to 60.0 °C. Accuracy +/- 0.1 °C. Uniformity +/- 1.0 °C
- Humidity range : 25% to 95% RH, Accuracy +/- 3% RH , Uniformity +/- 3% RH.
- Lamp type : Floroscent.
- UVA Intensities: 1.8 W/m² (requires about 111 hrs achieving ICH recommendation of 200W-hr/m²)
- VIS Intensities: 12 Klux (requires about 100 hrs achieving ICH recommendation of 1.2 million lux-hr)
- Temperature Display : Digital LED 3 ½ digit, Resolution 0.1 deg C
- Humidity Display : Digital LED 3 ½ digit, Resolution 1% RH.
- Heating system: U shaped Nichrome wire heater in SS Sheathing.
- Cooling system : Hermetically sealed CFC free Emerson compressor with R 134a refrigerant .
- Humidity system : Non condensing type steam injection system with water level arrangement with insulation to save heat energy.
- Air circulation : Flange Motor with Impeller and blower.
- Interior Illumination for working Area.
- There will be two nos of blower from 450 Ltr Onwords.
- Double walled , gap between walls filled with PUF Insulation.
- 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.
- Double door : Inner full Viewing door and outer door insulated with lock and key arrangement.
- 50mm Validation Port with silicon rubber seal to insert sensor for validation purpose.
- 3” Thick CFC Free Puff Insulation.
- Stainless steel Trays. Adjustable Tray Height adjustment.
- Unit Mounted on castor wheels with front lock arrangement.
- Microprocessor based PID temp. controller with auto tune facility for precise control of temperature and humidity.
- Temp. Sensor : PT- 100 , RH sensor : direct capacitance type.
- Cyclic timer for Light intensity.
- Dedicated safety controller with separate sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm.
- Recorder data bank to store and print set values , process values , date and time of master controllers with variable print time intervals ( Optional)
- Alarm : Audio visual alarm if temperature deviates from the preset temperature.
- PC Interface communication card with RS 485 for temperature and humidity control system ( Hardware only) ( optional)
- Over heat temperature and humidity cut off with alarm.
- Low temperature and humidity alarm.
- Low boiler water level safeguard.
- Electrical overload compressor cutoff.
- Time delay for compressor switch on.
- Electrical short circuit breaker.
- Distilled water or DM Water Line. ( consumption will be 20 ltrs/24 hrs upto 450 ltr Model )
- Room temperature around machine preferably at 25 degree C.
- Stabilised input voltage of 230V Ac, 50 Hz, 20 Amps.
- 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||SHELVES||WT IN KG||POWER|
|Standard||GMP||Cu. Ft||Litres||Chamber||Over All||–||Unit||Packed in wooden case||VAC Hz||Watts|
|HAMCO44 S -3||HAMCO44 G-3||3||90||45x45x45||60x95x110||2||110||165||230,50||1500|
|HAMCO44 S-4||HAMCO44 G-3||4||120||45x45x60||60x95x125||2||150||225||230,50||2000|
|HAMCO44 S-8||HAMCO44 G-8||8||200||60x60x60||80x110x125||2||220||300||230,50||2500|
|HAMCO44 S-12||HAMCO44 G-12||12||324||60x60x90||80x110x155||3||230||320||230,50||2500|
|HAMCO44 S-16||HAMCO44 G-16||16||450||60x60x125||80x130x175||4||340||430||230,50||4000|
|HAMCO44 S-21||HAMCO44 G-21||21||600||60x80x125||80x130x195||5||365||465||230,50||4000|
|HAMCO44 S-28||HAMCO44 G-28||28||800||80x80x125||100x130x210||5||390||500||230,50||4500|
|HAMCO44 S-34||HAMCO44 G-34||34||1000||80x80x155||100x130x220||5||430||525||230,50||4500|