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| CERTIFICATIONS | OUR CHAMBERS ARE CE Certified Chambers . We as company is ISO 9001:2008 Certified Company. |
| FEATURES | Consist of Chamber (Hamco 72 series) + RS 485 Communication card(PCI-1) + HMI PLC ( 4.3 Touch Screen PLC Display ) + DS ( Door Access System ) + SOFTW-21 (Desktop based Software Part 11 21 CFR ) + E-REPORT. |
| RANGE/ ACCURACY / UNIFORMITY | CHAMBER -1 (UPPER CHAMBER)
Temperature Range 5 TO 60 Deg C , Temperature Accuracy +/- 0.2C , Temperature Uniformity : +/- 1C . CHAMBER -2 ( LOWER CHAMBER ) Temperature Range Ambient to 60 Deg C , Temperature Accuracy +/- 0.2C , Temperature Uniformity : +/- 1C . |
|
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 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. Stainless steel Rod Trays. Adjustable Tray Height adjustment. |
| LIGHTING | Floroscent Light are provided , which automatically On when we open the door. |
|
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% . |
|
ICH GUIDELINES |
Fully Suitable to carry out Stability Studies For Conditions Such As : UPPER CHAMBER:-
20C 22.5C 25C LOWER CHAMBER 27.5C 32.5C 37.5C 42.5C 47.5C 52.5C 55C
Also Suitable for Low temperature ICH conditions Laid out for drug Products packed in Semi-Permeable Containers Other Than this cycle Please Mention it beforeorder. |
| APPLICATIONS | Application includes Microbiology , ARD Labs , Packing , Life science , Medical Storage & R&D activity. |
|
HEATING AND COOLING SYSTEM |
CHAMBER-1 (UPPER CHAMBER).
Heating system: U shaped Nichrome wire heater in SS Sheathing. Air circulation : Flange Motor with Impeller and blower. Interior Illumination for working Area. Cooling system : Hermatically sealed with CFC Free compressor utilizing R134a Eco friendly refrigerant with condenser, motor, and evaporator. There will be two nos of blower from 450 Ltr Onwords. CHAMBER-2 (LOWER CHAMBER). Heating system: U shaped Nichrome wire heater in SS Sheathing. Air circulation : Flange Motor with Impeller and blower. Interior Illumination for working Area. There will be two nos of blower from 450 Ltr Onwords. |
|
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 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. |
|
DISPLAY |
HMI Display is 4.3 Color Touch Screen Display of Godrej Make with display
shows set & Process Value of Temp of both chamber Active Alarm List Status of Component Password Protected Display Alarm List & its History. Graph Display of Temperature & Humidity. Limited Door Access through Password Protection. |
| 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 Sensor. |
| STAND BY COOLING SYSTEM (S.REF 1) | ——-N.A——– ( Only in Premium Model. In case of Failure of Comp 1 ,it
switch over to Comp2 , thus reduces down time) |
| TEMPERATURE SCANNER (SCN 4) | ——-N.A——– (Only in Premium Model , 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) | —-N.A——– ( Only in Premium Model , You will get SMS Alert on
critical utility paramenters like Temp High & Low Alarm, Humidity High & Low Alarm, Low water Level, Power Fail etc. |
|
CONTROLLING SYSTEM |
The controlling system is Fully PLC Based , It consist of HMI Display , PLC Digital & Analogue cards, Relays, Contactors, Overload Trip devices, MCB.
Separate Connection for Main & UPS ( UPS will be on Buyer Scope). This helps in recording the chamber conditions even during Power fail and capture the event of Power Fail & Resume during the conditions. The control panel has below features. IP 22 Protection. Data Storage of 10,000 Readings. If we set data interval of 30 Mins , it can save approx. one year data. Controls Temp & Humidity using PID Loops. Captures all the events Like Power OFF / Resume , Water Level Low/OK , Door Open/Close , etc. Operates as Safety Controller by cutting of Heating device on Over temperature , Cutting of Refrigeration device of Low Temperature, Cutting off Boiler on High Humidity etc and generates Alarms and transmit the same alarm to Multiple locations. RS 485 Communication Port for PC Connectivity. |
|
ALARM GENERATION |
Audio & Visual Alarms are generated for:
Temperature Deviation. Sensor Failure. Component Failure. Mains Failure. Door Open Water Level Low Thermostate High |
| PC COMMUNICATION (PCI-1) | PC Interface communication Card with RS 485 convertor (Hardware) for Temperature control system |
|
SOFTWARE 21 |
It is Desktop 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 |
