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.

These are medium to large-sized chambers that are custom-built to ensure that they not only fit optimally in your lab's stability area but also address your large-scale stability testing requirements.

Walk-In Chambers have now become a de-facto requirement for companies planning multiple ANDA filings & planning to launching various products simultaneously.

NEWTRONIC Walk-Ins ensure a smooth air-flow pattern to improve the temperature & humidity distribution across the chamber. This has also led to huge load reduction on the heating, cooling & humidifier systems. This & many other innovations in the construction & design aspects have ensured dramatic reduction in power consumption of our Walk-Ins.

NEWTRONIC has also been regularly exporting the Walk-In Chambers to all the major markets of the world. We ensure our products meet all kinds of country-specific requirements such as voltage specifications, regulatory needs, container shipping, etc

Photostability chambers are specifically designed to perform near UV and visual light testing with fluorescent lamps per ICH Q1B Guidelines, Option 2. This unit controls light and temperature conditions through an easy-to-use color touch-screen interface. Uniform light distribution and high intensity levels allow quick response for forced degradation testing and confirmatory studies. The confirmatory studies should identify precautionary measures needed in manufacturing or in formulation of the product, and if light resistant packaging is needed.

At the end of the exposure period, the samples should be examined for any changes in physical properties (e.g., appearance, clarity, or colour of solution) and for assay degradation.

Freeze Thaw or Cyclic Temperature stress tests are designed on the knowledge of the product so as to mimic likely storage conditions. The period of cycle is mostly considered 24 hours since the diurnal rhythm on earth is 24 hours.

Additionally, the distribution environment can vary greatly, especially when a drug product is shipped between various climatic zones. Seasonal changes, mode of transportation, and the number of drop-off points are also variables that should be considered within the pharmaceutical supply chain. Drug products requiring controlled-temperature storage conditions must be distributed in a manner that ensures that the product quality will not be adversely affected. With the exception of short transit times within the same climatic zone, it is virtually impossible to validate a shipping method against all environmental conditions.
Therefore, distribution stability studies are designed to generate additional data to complement preformulation development and routine (ICH) Q1A(R2).

NEWTRONIC Freeze Thaw Chambers control a broad temperature range of -20°C to 60°C thereby offering the flexibility to simulate a broad range of  conditions. The min temperature, max temperature & cyclic time are all user-settlable thereby allowing the user to program a specific profile for their studies. Automatic cycling between the set
points enables rapid simulation of conditions & the need to replicate freezing and thawing during product testing.

FEATURES

View & Acknowledge real-time T/RH readings of EACH sensor
View status of each I/O Components (humidifier, heater, compressor, etc)
View status of Utilities (Mains Supply, Door, Water Level)
Generate SMS for cntical alarms. SMS alerts to specific mobile nos. based on equipment ownership
Get real-time video feeds from IP-cameras