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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.

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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

 

 

              

 

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
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