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| CERTIFICATIONS | OUR CHAMBERS ARE CE Certified Chambers . We as company is ISO 9001:2008 Certified Company. |
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FEATURES |
Consist of Chamber (Hamco 70 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 ) + SCN-4 ( 4 Temp sensor ) +EX.HTR (External Hooter for alarm Transmission) + GSM (Mobile SMS Alert)
+EMAIL ( Email alert)+ VAL ( Validation) |
| RANGE/ ACCURACY / UNIFORMITY | UPPER CHAMBER :-
Temperature Range 5C to 60C , Temperature Accuracy +/- 0.2C , Temperature Uniformity : +/- 1C . LOWER CHAMBER :- Temperature Range 5C to 60C , Temperature Accuracy +/- 0.2C , Temperature Uniformity : +/- 1C . |
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CONSTRUCTION GMP MODEL |
Double walled , gap between walls filled with PUF Insulation. Inner Body made of SS 304 Mirror Finished, Outside SS 304 Matt Finished. 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. Stainless steel Rod Trays. Adjustable Tray Height adjustment. |
| LIGHTING | Floroscent Light are provided , which automatically On when we open the door. |
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CHAMBER PRINCIPLE |
Air circulation by Circulation Motor & Fan will continuously sucks the air from the chamber and Passes it through Air heater, Evaporator and through it back to chamber and same air will be recirculated to achieve desired Temperature stability inside chamber. Our design reduces the power consumption by 50% . |
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ICH GUIDELINES |
Fully Suitable to carry out Stability Studies For Conditions Such As :
22.5C 27.5C 32.5C 37.5C 42.5C 47.5C 52.5C 55C Or any other conditions within range. |
| APPLICATIONS | Application includes Microbiology , ARD Labs , Packing , Life science , Medical Storage & R&D activity. |
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HEATING & COOLING SYSTEM |
Heating system: U shaped Nichrome wire heater in SS Sheathing.
Cooling system : Hermetically sealed CFC free Emerson compressor with R 134a refrigerant . Air circulation : Flange Motor with Impeller and blower. Interior Illumination for working Area. There will be two nos of blower from 450 Ltr Onwords. |
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DQ,IQ,OQ,PQ |
To Help the customers to meet current regulatory requirements for the equipment , Hamco can provide DQ,IQ,OQ,PQ Protocols. This Protocol ensures that the system is properly installed, Operating as per our recommendations , Adequately documented and controlled according to regulatory requirements.
Calibration certificate & Test certificate of critical components along with Operation , Maintenance Manual, Wiring diagram , chamber diagram, sensor position diagram provided. Operation Training of the instruments along with software installation and software Training is part of our Operation Qualification. |
| VALIDATION & CALIBRATION | Calibration of chamber is provided with Treacability against standard used.
Hamco will give one cycle 24 hours Validation report offsite . ( Validation is putting temp & RH sensors at different position in the chamber confirming Uniformity at different places in the chamber. ) |
| TEMPERATURE SENSOR | A Grade RTD ( PT 100 Sensor) . Temperature resolution 0.1C . |
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DISPLAY |
HMI Display is 7 Color Touch Screen Display of Delta Make with display shows
set & Process Value of Temp & Humidity Active Alarm List Status of Component. Component running Hour display Password Protected Display Alarm List & its History. Graph Display of Temperature. Limited Door Access through Password Protection. |
| Auto changeover of Sensor on failure. | |
| DOOR ACCESS SYSTEM
(DS) |
Limited Door access through Password protection. The person with Authorised password can only open the door with reason . In
software we get the door access report which shows who open the door , when & for what reason with time stamp. |
| AUTO SENSOR CHANGEOVER (SAFETY-1) | In the case of Master Temp sensor Fails , it switch over to Standby Temp-RH Sensor. |
| TEMPERATURE SCANNER
(SCN 4) |
4 Temp including one Master Sensor Placed at different Position in the chamber to Study the distribution of conditions in the different locations of the chambers and thus helps in Auto- Validate the chamber and helps in easy detection of
Drift in the sensor) |
| MOBILE ALERT (GSM) | You will get SMS Alert on critical utility paramenters like Temp High & Low Alarm, Humidity High & Low Alarm, Low water Level, Power Fail etc. |
| EXTERNAL HOOTER (EX.HTR) | External Hooter which horns on active alarm works as alarm transmission system |
| EMAIL ALERT
(EMAIL) |
You will get EMAIL Alert on critical utility paramenters like Temp High & Low Alarm, Door Open, Thermostate High, Power Fail etc. |
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CONTROLLING SYSTEM |
The controlling system is Fully PLC Controller Based. It consist of Relays, Contactors, Overload Trip devices, MCB.
. The control panel has below features. IP 22 Protection. Controls Temp using PID Loops. Data storage upto 10000 Data Operates as Safety Controller by cutting of Heating device on Over temperature , Cutting of Refrigeration device of Low Temperature etc and generates Alarms and horns the buzzer. |
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SAFETY |
Temperature Safety :-
When Temperature deviates higher side than their prescribed limits , the Heater will be cut off by switchgears & if still go higher than by Thermostate. It generated alarm and horn the buzzer if it deviates. Once it reach within the range , the heating system reset automatically. When Temperature deviates lower side than their prescribed limits , the Compressor will be cut off by switchgears & if still go lower than by Thermostate. It generated alarm and horn the buzzer if it deviates. Once it reach within the range , the Refrigeration system reset automatically. Human Safety :- All the component has individual MCB for Overload and trip protection. The system has provided with proper earthing. |
| ALARM GENERATION | Audio & Visual Alarms are generated for :
Temperature Deviation. Power Fail. Emergency. Door Open. Thermostate High Thermostate Low |
| PC COMMUNICATION (PCI-1) | PC Interface communication Card with RS 485 convertor (Hardware) for Temperature control system |
|
SOFTWARE 21 |
It is Web Based Software. Having Below said Features .
All 21 CFR Part 11 Requirements are Met. GMP Compliant- Tamper Proof Documentation of Measured data. Can Connect 20 Chambers at a Time. Authorised Access Only. Auto Backup Facility. Password Expiry & Multi Wrong attempt of Password will block the User. Auto Logout for no activity during Prescribed Time. Unlimited Users , Multiple login levels. Can Created Data Log Report & Alarm for Temp & RH. Scanner & Scanner Alarm Report for Temp & RH. Event Log Report Door Access Report. HMI Audit Report Etc |
