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.

WALK-IN STABILITY (HUMIDITY) CHAMBERS WITH ECOTRONIC TECHNOLOGY
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
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