Stability (Humidity) Chambers
Stability Tests are an important step in the development of new drugs and pharmaceutical substances and an indispensable element in the licensing process defined by federal regulating authorities. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance.
Together with committees from the pharmaceutical industry, experts from the licensing authorities (such as the FDA) have developed the ICH Guidelines for the harmonization of stability tests. These guidelines define standardized storage and batch evaluation as well as the time sequence of the required analytic tests.
According to the ICH Guideline Q1AR2, stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances.
NEWTRONIC offers a range of test chambers to meet these regulatory requirements as well as stability testing requirements for other industry segments of Cosmetic, Food & Beverages, etc.
We offer a centralized solution across all ICH conditions of real-time, intermediate, accelerated & semi-permeable study conditions along with a state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features.
Features
ETHERNET COMMUNICATION
High-speed data transfer
Significantly faster than serial(RS-485) communication
Global standard for communication protocol
No need for a separate PC interface
Data Operations from any PC over the LAN
STANDBY HUMIDITY & COOLING SYSTEM
Completely ready-to-use systems
Automatic switch-over upon failure of primary systems to achieve conditions
Switch-over also upon detection of HP/LP & Internal fault
Scheduled & manual change-overs
Recording of all change-overs in the software
PLC-BASED CONTROL SYSTEM
Complete Operations driven through PLC
No Data Loss: Data Storage of upto 1000 readings on the PLC itself
At an interval of 30 mins, data upto 20 days is stored on the PLC itself
Facility to send emails directly from the PLC
TOUCH SCREEN DISPLAY
All operations through a single 4" Color touch screen display
PLC IP Address setting
Component Working Hours
Standby system change over
Password protection for set values and calibration mode
E-MAIL ALERT
When an alarm is triggered, an e-mail is sent to the registered PC or mobile address
*connection to a mail server is required to use e-mail alert.
COMPLETE RANGE OF ALARMS
Temperature & Humidity Deviations
Door Opening
Water Supply Failure
Component Failure
Mains Failure
DOCUMENTATION & TRAINING
IQ, OQ, PQ
Calibration certificates
Operations & maintanance manuals
GA & Electrical drawings
Material test certificates
Training to end-users
SAFETY
Temperature Overshoot/Undershoot
Humidity Overshoot
Low water-level
Delay Timer to safeguard the Compressor
MCB to cut-off over-current supply
Standby Controlling Sensor upon failure of Primary
In Walk-in chambers door can be open from inside
Emergency Bell switch inside the Chamber
ICDAS SOFTWARE
21 CFR Part 11 Ready
Single software suitable for upto 20 equipments
Automatic daily data back-up
Alarm logs. Alarm acknowledgement with e-signatures
Audit trails
MKT Calculations
Graphical viewing & data trending
Data export in pdf format
TOUCH SCREEN DOOR ACCESS SYSTEM
Password based access control
Restricts access to unauthorized persons
ALARM TRANSMISSION
Mobile alert system
Time of alarm transmission
Name of equipment
Transmitted message(Equipment name, alarm time,type of alarm & limits)
Galary
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Specification
| Temperature Range | 20°C to 60°C |
| Temperature Accuracy | ± 0.2°C |
| Temperature Uniformity | ± 1°C |
| Humidity Range | 40% RH to 95% RH |
| Humidity Accuracy | ± 2% RH |
| Humidity Uniformity |
± 3% RH |
Standard Equipment
| Double walled with 80mm PUF insulated modular panels with easy on-site assembly | System is made up of split type condenser unit in well-ventilated area to avoid throw of hot air in the room |
| SS 304 Interior & Exterior either SS 304 or Powder Coated G.I. | Stand by humidity system |
| Stainless Steel Trays | Complete Operations driven through PLC with data logging capacity of upto 1000 readings & email facility |
| Full length Inner glass door | High speed Ethernet based communication |
| Illuminated working area | All operations through a single 4" Color Touch Screen |
| U-shaped SS tubular heaters | High-quality German Make temperature humidity sensor with 4-20mA output |
| Forced air circulation for uniform temperature | Safety devices: Low & High temperature cut-off settable thermostats & high humidity cut-off device |
| Non Condensing steam injection type humidity system with standby heater & auto switch overs | Audio/Visual alarms for deviations |
| CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser | Complete with DQ, OQ, PQ, IQ & Operations & Maintenance Manual |
Optional Accessories
| ICDAS – A Single Software installation for all Newtronic make equipment. | Door Access system (Numeric or Biometric) |
| 4pt. Temperature & Humidity Scanners | Mobile Alert system |
| Stand by Cooling System with auto switch overs (430 litre & above) | Remote alarm system suitable for 4 nos. Newtronic make equipments |
Selection Guide
Models |
Capacity CuFt |
Capacity Liter |
Internal Dimension (H*W*D )mm |
External Dimension (H*W*D) mm |
Trays Qty. |
Tray size (mm) |
Approx. Weight (kg) Eqip |
Approx. Weight (kg) Ship |
|---|---|---|---|---|---|---|---|---|
| NLHC7SI | 7 | 200 | 800x500x500 | 1350 x 630 x 945 | 3 | 430x460 | 150 | 225 |
| NLHC16SI | 16 | 430 | 1200x600x600 | 1795 x 730 x 1095 | 4 | 530x560 | 250 | 325 |
| NLHC26SI | 26 | 735 | 1500x700x700 | 2095 x 895 x 1185 | 5 | 630x660 | 300 | 400 |
| NLHC34SI | 34 | 1000 | 1500x800x800 | 2095 x 930 x 1295 | 5 | 730x760 | 325 | 425 |
| NLHC54SI | 54 | 1500 | 1500x1600x600 | 2095 x 1730 x 1085 | 10 | 710x560 | 350 | 450 |
| NLHC71SI | 71 | 2000 | 1500x1600x800 | 2095 x 1760 x 1285 | 10 | 710x560 | 375 | 475 |
