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.
Offers high-speed data transfer, surpassing serial (RS-485) communication, and adheres to a global standard for communication protocol, enabling data operations from any PC over the LAN without requiring a separate PC interface.
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.
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.
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.
IQ, OQ, PQ, Calibration certificates, Operations & maintenance manuals, GA & Electrical drawings, Material test certificates, Training to end-users.
Temperature & Humidity Deviations, Door Opening, Water Supply Failure, Component Failure, Mains Failure.
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.
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.
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.
Password based access control & Restricts access to unauthorized persons.
Mobile alert system, Time of alarm transmission, Name of equipment, Transmitted message(Equipment name, alarm time, type of alarm & limits).
Temperature Range | 20°C to 60°C |
Temperature Accuracy | ± 0.5°C |
Temperature Uniformity | ± 1°C |
Humidity Range | 40% RH to 95% RH |
Humidity Accuracy | ± 2% RH |
Humidity Uniformity | ± 3% RH |
Double walled with PUF insulation. | Stainless Steel trays |
SS 304 Interior & Exterior either SS 304 or Mild Steel | Full-length inner glass door & metal door with gasket & lock on the outside |
Internal LED lights | Forced air circulation for uniform temperature |
PU wheels for easy movement | U-shaped SS tubular heaters |
Non condensing steam injection type humidity system with standby heater & auto switch overs | CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser |
Stand by humidity system with booster humidification | Complete Operations driven through PLC with data logging capacity of upto 1000 readings |
High speed Ethernet based communication | All operations through a single 7″ Color Touch Screen |
High quality imported make T/Rh combo sensor with 4-20 mA output | Safety devices: Low & high temperature cut-off settable thermostats |
Audio/Visual alarms for deviations | Complete with DQ, IQ, OQ, PQ & SOP & Maintenance Manual |
ICDAS – A Common Software suitable for 20 nos. Newtronic make equipments | Door Access system (Numeric or Biometric) |
4pt. Temperature & Humidity Scanner | Mobile Alert system |
Stand by Cooling System with auto switch overs (430 litre & above) | Remote alarm system suitable for 4 nos. Newtronic make equipments |
Model | Capacity – CuFt. | Capacity – Litres | Internal Size – (HxWxD) mm | External Size – (HxWxD) mm | Trays Qty. | Tray Size – (WxD) mm | Approx. Weight – Eqip. Kg | Approx. Weight – Ship. Kg |
---|---|---|---|---|---|---|---|---|
NLHC7SI | 7 | 200 | 800 x 500 x 500 | 1315 x 660 x 985 | 3 | 430 x 460 | 150 | 225 |
NLHC16SI | 16 | 430 | 1200 x 600 x 600 | 1715 x 760 x 1155 | 4 | 530 x 560 | 250 | 325 |
NLHC26SI | 26 | 735 | 1500 x 700 x 700 | 2070 x 860 x 1255 | 5 | 630 x 660 | 275 | 350 |
NLHC34SI | 34 | 1000 | 1500 x 800 x 800 | 2070 x 960 x 1355 | 5 | 730 x 760 | 350 | 425 |
NLHC54SI | 54 | 1500 | 1500 x 1600 x 600 | 2070 x 1760 x 1155 | 10 | 695 x 560 | 350 | 450 |
NLHC71SI | 71 | 2000 | 1500 x 1600 x 800 | 2070 x 1760 x 1355 | 10 | 695 x 760 | 375 | 475 |
Temperature Range | 20°C to 60°C |
Temperature Accuracy | ± 0.5°C |
Temperature Uniformity | ± 1°C |
Humidity Range | 40% RH to 95% RH |
Humidity Accuracy | ± 2% RH |
Humidity Uniformity | ± 3% RH |
Double walled with PUF insulation. | Stainless Steel trays |
SS 304 Interior & Exterior either SS 304 or Mild Steel | Full-length inner glass door & metal door with gasket & lock on the outside |
Internal LED lights | Forced air circulation for uniform temperature |
PU wheels for easy movement | U-shaped SS tubular heaters |
Non condensing steam injection type humidity system with standby heater & auto switch overs | CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser |
Stand by humidity system with booster humidification | Complete Operations driven through PLC with data logging capacity of upto 1000 readings |
High speed Ethernet based communication | All operations through a single 7″ Color Touch Screen |
High quality imported make T/Rh combo sensor with 4-20 mA output | Safety devices: Low & high temperature cut-off settable thermostats |
Audio/Visual alarms for deviations | Complete with DQ, IQ, OQ, PQ & SOP & Maintenance Manual |
ICDAS – A Common Software suitable for 20 nos. Newtronic make equipments | Door Access system (Numeric or Biometric) |
4pt. Temperature & Humidity Scanner | Mobile Alert system |
Stand by Cooling System with auto switch overs (430 litre & above) | Remote alarm system suitable for 4 nos. Newtronic make equipments |
Model | Capacity – CuFt. | Capacity – Litres | Internal Size – (HxWxD) mm | External Size – (HxWxD) mm | Trays Qty. | Tray Size – (WxD) mm | Approx. Weight – Eqip. Kg | Approx. Weight – Ship. Kg |
---|---|---|---|---|---|---|---|---|
NLHC7SI | 7 | 200 | 800 x 500 x 500 | 1315 x 660 x 985 | 3 | 430 x 460 | 150 | 225 |
NLHC16SI | 16 | 430 | 1200 x 600 x 600 | 1715 x 760 x 1155 | 4 | 530 x 560 | 250 | 325 |
NLHC26SI | 26 | 735 | 1500 x 700 x 700 | 2070 x 860 x 1255 | 5 | 630 x 660 | 275 | 350 |
NLHC34SI | 34 | 1000 | 1500 x 800 x 800 | 2070 x 960 x 1355 | 5 | 730 x 760 | 350 | 425 |
NLHC54SI | 54 | 1500 | 1500 x 1600 x 600 | 2070 x 1760 x 1155 | 10 | 695 x 560 | 350 | 450 |
NLHC71SI | 71 | 2000 | 1500 x 1600 x 800 | 2070 x 1760 x 1355 | 10 | 695 x 760 | 375 | 475 |