Business Sectors

We provide Amazing Solutions

Area of Appplications

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Pharmacuticals

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 of vaccines.
Cold Room Solutions are used for the storage of those critical products where the temperature plays a critical part.
Stability Table has to be copy pasted.

Cosmetics

Our Chambers are used in the cosmetics industry to ensure its product stability especially for the Photostability and Weather changes. Incubators are used to make raw materials. Freeze-Thaw Chamber plays a vital role in determining if the final product and its packing are weatherproof.

Green House

Newtronic invests a lot in continuous innovation. As part of this program, We have developed products that are designed for the GreenHouse Industry. The Plant Growth Chamber is used for a number of applications like botany research, Seed germination etc.

Aerosol

Aerosol Industry deals with flammable materials. They have a strict fire safety rules. Newtronic Has developed a Flame Proof Chamber.This Chamber complies with the fire safety norms of FM200 system.

Biotechnology

Incubator is a device used to grow and maintain microbiological cultures or cell cultures.

This Industry works on the research of microbiological cultures and cell cultures. They Need to be grown in artificial environment. Newtronic Incubators are widely used in this application by many biotechnology labs.

Warehouse

Warehousing have standards to be followed. Specially when the warehouse comes under the USFDA scanner. Our cold room storage systems are designed as per the ICH and other Statutory compliance bodies.

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