Stability Chambers: Controlled Testing with Newtronic Lifecare Equipment

In the pharmaceutical, biotechnology, and life sciences industries, proper environmental control is pivotal for carrying out tests and validation. Stability Chambers from Newtronic Lifecare Equipment come in handy at this juncture to help manage this situation. Compliance is another area where our stability chambers are second to none: certified to ICH guidelines and GMP standards, they ensure industry-leading uniformity, accuracy, reliability, and control.

What Are Stability Chambers?

A stability chamber is a specific chamber intended for testing the stability, shelf life as well as performance of individual products at desired relative humidity and temperature. These are used to emulate different climatic environments with a purpose of determining the durability of a given product. These are requisite tools in pharmaceutical research companies and development, cosmetics and even the food industry.

These chambers at Newtronic Lifecare are designed and constructed for accurate storage conditions compliance with the global market's standards.

Why Choose Newtronic Stability Chambers?

  • ICH Compliance: Newtronic stability chambers are provided to meet the requirements of ICH Q1A (R2) so as to provide reliable results for test conditions.
  • Precise Control: Newtronic chambers also come with fully programmable, digital controllers, sensors and uniform air circulation that provides optimum control of the temperature holding, with a variation of ±0.5°C and relative humidity control, ±3%RH.
  • Energy Efficient Design: Optimized insulation, utilisation of environment-friendly refrigerants, and intelligent compressors help in utilizing less power in operation and make it economical.
  • Custom-Built Solutions: Newtronic provides walk-in and reach-in stability chambers with a range from small quantity for testing, to large quantity for production or production line use.
  • Advanced Monitoring & Alarms: When you’re trialing the software you will have Real-time data logging and monitoring, including 21 CFR part 11 compliance, in addition to remote monitoring, so you’ll always be informed and compliant.

Key Features of Newtronic Stability Chambers

  • Temperature range: 10°C to 60°C
  • Humidity range: 40% to 95% RH
  • To ensure long life and corrosion-free working, the equipments are provided in Stainless Steel
  • For convenient control and management of the whole operation, the use of PLC/HMI control systems is adopted
  • Sufficient fallback mechanisms for critical components such as compressors and humidifier

Why Stability Testing Matters

Stability testing also helps to determine whether the product is safe, effective, and of high quality within the shelf life that is expected. The likes of the FDA, MHRA, EU-GMP, TGA and WHO demand stability testing data before granting approval for products to be released on the market.

Newtronic Lifecare Equipment provides precision chambers, which meet the regulatory requirements, decrease test variability, and enhance the quality of the tested product.

Conclusion

Newtronic Stability Chambers is the right choice for those who are in need of a stable study management solution that is innovative, flexible, and reliable. Based out of India, Newtronic Lifecare has over 30 years of experience in the manufacturing of Life Sciences equipment and to provide high-quality environmental testing services, which are accordance with the current governing laws and guidelines.

Send Enquiry: enquiry@newtronic.in