Business Sectors

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Area of Appplications

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Pharmaceuticals

  • Our Chambers are used widely in the pharmaceutical industry for the testing and shelf life determination of drugs and medicines.
  • Incubators are used for the production and research of vaccines.
  • Cold Rooms are used for the storage of those critical products where the storage temperature plays a critical part.
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Cosmetics

Our Chambers are used in the cosmetics industry for product stability test.

  • Photostability Chambers are used for the product testing against exposure to UV rays.
  • Incubators are used to make raw materials.
  • Freeze-Thaw testings are done to ensure the products are weather proof.
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Food and Beverages

We have a lot to offer for the food and beverages industries. The Cooling Chambers are used for the storage of Fruits, Food Grains, Liquids ets. The Incubators find applications in Milk Industry, Bakery, Poultry.

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Agriculture Studies

Newtronic believes in continous innovation. As part of this program, we have developed a product for the Green House Industry. Instead of taking your plants to the weather, bring the weather to your plants using the "Plant Growth Chamber"

Aerosol

Looking at the challenges in the Aerosol Industry, Newtronic presents the FlameProof Walk-in Chambers. This Chamber is designed to retard fire incase it occurs from the flammable samples that can further damage the lab or manufacturing facility.
The Chamber adheres to the various international fire saftey norms like FM200.

Biotechnology

The Biotechnology and the Microbiology Industry are constantly reseaching for new creations. Everyday the demand of new drug arises out of the market.
For this the industry need incubators and stability chambers that match international guidelines helping them boost their research studies.

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Warehouse

Pharma Products can have their intended effects only when their quality and potency is preserved from production to consumption. This means that great care must be taken throughout the supply chain to keep these drugs in safe, optimal conditions.

WHY STABILITY STUDIES?

Successful Stability Studies have become a must criteria to meet the regulatory requirements of the various international bodies such as ICH, FDA, TAPPI, TGA, JPMMA, MHRA, ANVISA, ASEAN or any of the National Testing Standards.

APPLICATION

  • The primary reason for stability testing is the concern for the well-being of the patient suffering from the disease for which the products are being designed.
  • Degradation of the unstable product into toxic decomposition products not only results in loss of product activity but may lead to failure of the therapy resulting in death.
  • It has become a legal requirement to provide data for stability tests for the regulatory agencies before launching a new product commercially.
  • Stability studies protect the reputation of manufacturer by assuring that the product will retain its fitness for use with respect to quality as long as it is in market.
  • Translation Support
  • Other benefits of stability studies at developmental stage or marketed products are to provide database that may be of value in selection of adequate formulations, excipients and container closure system for development of new products.

Stability Guidelines

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STUDY CONDITIONS STUDY PERIOD APPLICATION GUIDELINES
Long Term 25° C ± 2° C / 60% RH ± 5% RH
30° C ± 2° C / 65% RH ± 5% RH
30° C ± 2° C / 75% RH ± 5% RH
12 months General Conditions ICH Q1 A (R2)
Accelerated 40° C ± 2° C / 75% RH ± 5% RH 06 months Drug Products packed in Semi-permeable containers
Long Term 25° C ± 2° C / 40% RH ± 5% RH
30° C ± 2° C / 35% RH ± 5% RH
12 months
Intermediate* 30° C ± 2° C / 65% RH ± 5% RH 06 months
Accelerated 40° C ± 2° C / NMT 25% RH 06 months Drug products for storage in Refrigerator
Long Term 5° C ± 3° C 12 months
Accelerated 25° C ± 2° C / 60% RH ± 5% RH 06 months Drug products intended for storage in a Freezer
Long Term -20° C ± 5° C 12 months
Photostability Exposure to Light intensity of 1.2 million Lux Hours & UV Light intensity of 200 watt / sq. mtr. ICH Q1 B
Other Conditions + 50° C / Ambient RH 60° C ± 2° C / 75% RH ± 5% RH