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

Protecting the integrity of your work is imperative which is why laboratories rely only on NEWTRONIC for their expertise in high quality refrigeration solutions. Our full line of refrigerators provide superior temperature uniformity, reliability and an eco-friendly construction for the safe storage of working and reference standards, vaccines, reagents, raw materials and other critical samples.

NEWTRONIC chambers have become the defacto standard for stability studies of Refrigerated Products.

They also come with specially designed trays for segregating Working Standards & Reference Standards samples for effective storage & quick retrieval.

The chambers are connected through Ethernet to 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.

Remember, your lab is not a kitchen! And therefore, domestic fridges can never be a substitute to industrial refrigerators.

The concept of storage of critical samples is no more limited to having a simple room with temperature between 2ºC to 8ºC.

Such ineffective solutions lead to excursions in temperature conditions that affect the quality of the stored material over a period in time.

NEWTRONIC Walk-In Cold Rooms ensure the temperature is uniform & within range throughout the room. Customer can also avail the option of 8 probe monitoring with data logging, trending & real-time alarms.

They are supplied at customer-site in a knock-down condition & can pass through standard sized doorways. They are assembled on-site. The installation & commissioning is accompanied with IQ, OQ, PQ protocols & complete documentation.

NEWTRONIC Cold Rooms can be utilized for multiple applications in the Pharmaceutical, Cosmetic, Food & Beverages, Dairy & other industries for all kinds of products intended for storage at low temperatures.

For drug products intended for storage at sub-zero temperatures, NEWTRONIC Deep Freezers provide a very optimal solution by offering a wide temperature range from 0ºC upto -20ºC.

NEWTRONIC Deep Freezers are equipped with a Standby Cooling System to significantly minimize breakdowns. The switchover to Standby system is automatic & immediate upon detection of a fault in Primary. If desired, the switchovers can also be scheduled or manual ones.

They also offer automatic defrost by utilizing a heater to defrost the condenser coils, which cycles on and off, preventing any ice build-up. Their robust compressors and CFC-free insulation help ensure temperature uniformity and sample protection.

For drug products intended for storage at sub-zero temperatures, NEWTRONIC Deep Freezers provide a very optimal solution by offering a wide temperature range from 0ºC upto -20ºC.

NEWTRONIC Deep Freezers are equipped with a Standby Cooling System to significantly minimize breakdowns. The switchover to Standby system is automatic & immediate upon detection of a fault in Primary. If desired, the switchovers can also be scheduled or manual ones.

They also offer automatic defrost by utilizing a heater to defrost the condenser coils, which cycles on and off, preventing any ice build-up. Their robust compressors and CFC-free insulation help ensure temperature uniformity and sample protection.

We have developed a revolutionary ultra-low temperature freezer that seamlessly joins the ranks of proven NEWTRONIC products in terms of reliability as well as setting new standards for safety. In addition, our commitment to after sales-support & service ensures satisfaction throughout the life of your product. Whether storing blood products, reagents, vaccines, or medication, a NEWTRONIC product offer true protection.

We are introducing an intelligent freezer with unique features of extended warm-uptime, remote monitoring, SMS alerts. Constructed from high-quality proven components with energy-efficient refrigeration design, ULT freezers provide top notch performance that can withstand the test of time to guarantee the integrity of your samples.

We have developed a revolutionary ultra-low temperature freezer that seamlessly joins the ranks of proven NEWTRONIC products in terms of reliability as well as setting new standards for safety. In addition, our commitment to after sales-support & service ensures satisfaction throughout the life of your product. Whether storing blood products, reagents, vaccines, or medication, a NEWTRONIC product offer true protection.

We are introducing an intelligent freezer with unique features of extended warm-uptime, remote monitoring, SMS alerts. Constructed from high-quality proven components with energy-efficient refrigeration design, ULT freezers provide top notch performance that can withstand the test of time to guarantee the integrity of your samples.

Compact in size, can be easily carried anywhere
Can be easily carried in vehicles & directly powered by vehicle battery output
DC compressor cooling system
Available with both 12 or 24 volts and 240 volts cords
Automatic temperature control with digital LED display

USB Temperature data logger for transport monitoring (optional)

B.O.D. stands for Bacteriological Oxygen Demand. NEWTRONIC's BOD Incubators are ideal for the growth & storage of bacterial cultures, gentle incubation & conditioning and Media Preparation.

Media Prepartion & Culture growth at temperatures of 22.5°C (±2.5°C) & 32.5°C (±2.5°C) have become a standard practice in any Microbiology or ARD labs.

The chambers ensure consistent performance at any temperature within a range of 5°C to 60°C at an accuracy of ±0.5°C & at an uniformity of ±1°C.

The chambers are provided with a glass door for sample viewing & quick retrieval. They are connected through Ethernet to 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 so as to comply with regulatory guidelines.

These are the medium to large-sized versions of BOD Incubators with similar application of growth & storage of bacterial cultures, gentle incubation & conditioning and Media Preparation.

Walk-In Incubators are ideal for incubation of micro-organisms, eggs, etc to cater to mass-scale production of vaccines & other drug products.

While Humidity is not a parameter to be controlled or measured in a Walk-In Incubator, it is important that there is no loss of humidity in the chamber since it can lead to cracks in the media.

The design team at NEWTRONIC ensure that our Walk-In Incubators are designed to fit into such key requirements perfectly well. 

They are supplied at customer-site in a knock-down condition & can pass through standard sized doorways. They are assembled on-site. The installation & commissioning is accompanied with IQ, OQ, PQ protocols & complete documentation.