Kesar Stability testing chambers are designed to meet, if not exceed, stringent quality standards recognized internationally.
Construction
- Stainless Steel Sandwich Type 75 MM Thick PUF- filled Body
- Inner MOC of Chamber:- S.S. 304/316
- Outer MOC of Chamber:- S.S. 304
- PUF Insulation Density:- 40kg/Meter³
- Wire Meshed type S.S. Trays are Provided (MOC:- S.S. 304/S.S. 316)
- Double-walled PUF-filled S.S. Door is provided along with Silicon Gasket for airtight sealing.
- Mechanical lock & Key provision is provided for Door.
- Master Sensor for temperature is provided for controlling of chamber
- The Control Panel, cooling system, & Air circulation blower are provided with the attention of all standard parameter
Temperature :
- Range:- 20°C to 60°C
- Accuracy:- 0.2 °C
- Uniformity:- 1.0°C
Humidity :
- Range:- 40 % to 95 %
- Accuracy:- 2.0 %
- Uniformity:- 3.0 %
Operating Conditions As per ICH Guideline:- 25°C/60% RH, 30°C/65% RH, 30°C/75%RH, 40°C/75% RH
Also suitable to meet low humidity ICH conditions laid out for drug products packed in semi-permeable containers such as: 25°C/40% RH, 30°C/35% RH, 30°C/65%RH
TEMPERATURE :
- TEMPERATURE LOW ALARM (°C.LA) :- Audio & Visual alarm against low limit of temperature set value with cut-off the cooling system
- TEMPERATURE HIGH ALARM (°C.HA) :- Audio & Visual alarm against high limit of temperature set value with cut off the air heater
- TEMPERATURE LOW CUT OFF (°C.LC) :- Audio & Visual alarm against low cut off limit of temperature set value with shut down the power supply of chamber. Restart
- TEMPERATURE HIGH CUT OFF (°C.HC) :- Audio & Visual alarm against High cut off limit of temperature set value with Shut down the Power supply of chamber.
HUMIDITY :
- RH LOW ALARM (%RH LA) :- Audio & Visual alarm against low limit of RH set value
- RH HIGH ALARM (%RH HA) :- Audio & Visual alarm against high limit of RH set value with cut off the Steam Generator
- RH HIGH CUT OFF (%RH HC) :- Audio & Visual alarm against high cut off limit of RH set value with Shut down the Power supply of chamber.
ADDITIONAL SAFETY & FEATURES :
- Safety Cut Off :- A High Temperature Thermostat is provided for as an additional safety against Temperature overshoot.
- Low Water Level Safety Of Steam Generator :- In the event of Low water level in the steam generator tank, water level switch gives low water signal to PLC, for change over on standby steam generator or vice versa (Note:- If Both Steam generator's water will be low, then Chamber will be shut down with the message of low water level)
- Auto Change Over :- This function is applicable as per logical program to Cooling & Humidity Systems, in Case of Regular/running System fails to Maintain the chamber's condition, then the PLC change over on standby system to maintain the chamber condition automatically (I.e. Prevents the breakdown of chamber)
- Manual Change Over :- operator can manually change over the standby systems (Cooling or Humidity systems) from running systems as a predictive maintenance of chamber
- Time based changeover of cooling systems :- Timer can be set for time base changeover of cooling systems for the precaution of the idle condition of cooling system.
Door Operation :
- 5 Nos. User Password Can Be Set.
- Chamber Entry:- password access through HMI with Message of "DOOR OPEN ENTRY USER:-X"
- Chamber Exit :- By Exit button inside the chamber with Message of "DOOR OPEN EXIT:-X"
- 4. If door will be open More than 10 Minute then alarm will be buzz with message of "DOOR IS OPEN"
Emergency Stop : for instant stopping of chamber in the event of emergency, Emergency Button is provided on front of chamber for fast action in Emergency. Person Trapped Precaution : An Emergency Push button is provided inside the chamber for trapped person can exit from chamber by pressing that push button. Once push button is pressed, chamber will be shutdown and restart with reset button.
Silent Features of "Examine Web Pro" Software
- Meets all 21 CFR part 11 requirements
- Ethernet communication with PLC
- Secured audit trail with date and time stamp ( users, equipments, all events/alarms, SMS)
- Real time analysis & graphical analysis
- All connected equipment’s utility status, process parameters, & active alarms can online observed by software
- Auto & manual backup with restore data facility
- No limit for user account creation
- Forced password change on first time login
- Frequency based password expiry
- Account block with 3 wrong login attempt (unblock only by administrator)
- 8 to 20 alphanumeric password length
- Online downloading for all stored data of PLC, such that master data, scanner data, mkt calculation, event/alarms, master graph, & scanner graph
- GMP–compliant, tamper-proof reports of measured data
- Suitable for all PLC based equipments made by KESAR
