• What is Cooling Incubators :

Cooling Incubators which known as Biological Oxygen Demand Incubators is the chamber which maintain temperature at high accuracy and Uniformity in the temperature range of 10 to 60 Deg C.

  • Use of the Cooling Incubators :-

Cooling Incubators are used to test tissue culture growth, storage of bacterial cultures and incubation. It also helps in determining levels of organic matter and nitrogen in waste water samples. The Cooling Incubators provide require temperature for the growth of microorganismsand allows to perform the Cooling testing.

  • What is the Cooling Incubator Guidelines :

    ICH Guidelines , WHO Guidelines, cGMP guideline for shelf life study.

  • Storage Conditions :
Storage temperature (C) Set temperature (C)
20 C to 25 C 22.5 C
25 C to 30 C 27.5 C
30 C to 35 C 32.5 C
35 C to 40 C 37.5 C
  • Why 21 CFR Software compliance require?

The major challenges that the auditor has that all the data submitted of the testing should be authentic and non tempered. This will only possible if it is 21 CFR Complied data is there. Thats why it is important to have stability chamber with 21 cfr complied compliance.

  • What is DQ,IQ,OQ,PQ documents?

Normally Manufacture gives the User set of documents or say checklist kind of documents which on completition of doing will check the Stability chamber thoroughly on all the parameters.

Terminology Full Form Use
DQ Design Qualification This confirm that How de design the chamber and why certain component has been selected.
IQ Installation Qualification This confirm How to Install the equipment by checking all the component Make, sl No and certificate, Preinstallation requirement and Utilities.
OQ Operational Qualification This confirm the operation wise checking of all the paramenter of the equipment.
PQ Performance Qualification This confirm the performance qualification of the stability chamber.
  • What is Validation of the chamber and its protocol?

Validation means checking the performance of the chamber on accuracy and uniformity by placing sensors at different location for specified time interval and checking report for its Confirmatory. Normally Validation will be Onsite ( Checked by the Manufactory on its location ) and offsite at Buyer location. It will be empty, Part load and Full Load depending on the validation protocol.

  • Why Hamco?

Hamco has reach experience in designing and manufacturing stability chamber since last 15 years. We are having more than 1000 successful installation in India and globe. We are strong service support with In house manufacturing and software design capabilities.

  • Type of COOLING Incubators.

Hamco is making below said Table series COOLING Incubator

Series What it Includes Benefits
PID Series Hamco 42 Series Chamber Only. No USFDA, WHO , GMP Compliance
Normal series Consist of Chamber (Hamco 42 series) + RS 485 communication Card (PCI-1) + Data Logger (RCR-11 + SOFTD-21 (Desktop browser based Software Part 11 21 CFR )

 

WHO Complied
ECO Series Consist of Chamber (Hamco 42 series) + RS 485 Communication card(PCI-1) + HMI PLC ( 4.3 Touch Screen PLC Display ) + DS ( Door Access System ) + SOFTW-21 (Web based Software Part 11 21 CFR ) WHO, USFDA, GMP Complied
Premium Series Consist of Chamber (Hamco 42 series) + Ethernet Based Connectivity + HMI PLC ( 7 Touch Screen PLC Display ) + DS ( Door Access System ) + SOFTW-21 (Web browser based Software Part 11 21 CFR ) + S.REF-1 ( Standby Refrigeration System) + SCN-4 ( 4 Temp) + VAL ( Validation)

 

WHO, USFDA, GMP Complied.

Redundency for Failure of any component for Long studies.

Scanner for Auto validation of the chamber.

Mobile and E-mail alert for critical alarm to deliver on mobile or e-mail.

Heating and Cooling Chamber with Humidity Standard & GMP Model

“HAMCO” ‘HEATING AND COOLING CHAMBER WITH HUMIDITY CONTROL’ is designed primarily to meet the requirements for tests of thermal shock and various industrial applications. These chambers are designed to meet the testing challenge of vary industrial application.

HAMCO Make GMP ‘HEATING AND COOLING CHAMBER WITH HUMIDITY CONTROL’ is 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 -40 °C to 250.0 °C, Humidity 40 to 95%RH, Accuracy +/- 0.5 °C. Uniformity +/- 2.0 °C
  • Temperature Range -20 °C to +175.0 °C, Humidity 40 to 95% RH, Accuracy +/- 0.5 °C. Uniformity +/- 2.0 °C
  • Temperature Display : Digital LED 3 ½ digit, Resolution 0.1 deg C
  • Heating system: U shaped Nichrome wire heater in SS Sheathing.
  • Cooling system: Hermetically sealed CFC free Emerson compressor with R 23a refrigerant .Cascade system.
  • Air circulation: Flange Motor with Impeller and blower.
  • Interior Illumination for working Area.
  • There will be two nos of blower from 450 Ltr Onwards.
  • Double walled, gap between walls filled with PUF Insulation.
  • Standard Model: Stainless steel Mirror polished chamber and heavy gauge 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 silicone 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.
  • Temp. Sensor: PT- 100.
  • Dedicated safety controller with separate sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm. ( Optional)
  • 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 with alarm.
  • Electrical overload compressor cut off.
  • Time delay for compressor switch on.
  • Electrical short circuit breaker.
  • 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.
  • Room temperature around machine preferably at 25 degree C.
  • Stabilised input voltage of 230V Ac, 50 Hz, and 20 Amps.
  • Water drains line with ½” Nozzle to be provided at floor level.

Ordering Information:

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
HAMCO65S -3(-20) HAMCO65 G-3(-20) 3 90 45x45x45 60x95x110 2 110 165 230,50 1500
HAMCO65 S-4(-20) HAMCO65 G-3(-20) 4 120 45x45x60 60x95x125 2 150 225 230,50 2000
HAMCO65 S-8(-20) HAMCO65 G-8(-20) 8 200 60x60x60 80x110x125 2 220 300 230,50 2500
HAMCO65 S-12(-20) HAMCO65 G-12(-20) 12 324 60x60x90 80x110x155 3 230 320 230,50 2500
HAMCO65 S-16(-20) HAMCO65 G-16(-20) 16 450 60x60x125 80x130x175 4 340 430 230,50 4000
HAMCO65 S-21(-20) HAMCO44 G-21(-20) 21 600 60x80x125 80x130x195 5 365 465 230,50 4000
HAMCO65 S-28(-20) HAMCO44 G-28(-20) 28 800 80x80x125 100x130x210 5 390 500 230,50 4500
HAMCO65 S-34(-20) HAMCO44 G-34(-20) 34 1000 80x80x155 100x130x220 5 430 525 230,50 4500

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