Few of our Stability Chamber Equipments:
Stability Chamber Overview
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About Stability Chamber
VackerGlobal Stability Chambers are perfectly designed and developed to match the high demands of climatic tests and stability studies. The characteristics of the chambers meet the FDA/ICH stability requirements generating out of the ordinary control as well as a uniform temperature and humidity.
Furthermore, VackerGlobal Stability Chambers features numerous safety attributes, audiovisual alarms, 21 CFR part 11 software, and a wide range of selection which is the most preferred choice for stability studies.
Every VackerGlobal Stability Chamber repeatedly produces certain guidelines, structural integrity in order to keep the chamber working smoothly through years of vigorous testing cycles and measuring the equipment that accurately records the test data.
Validation
Stability chambers are ideal in terms of storage, shelf-life, packaging and stability. There are two types of chamber available; one with temperature only and the other one with both temperature and humidity. The size ranges from reach-in to walk-in, while temperature ranges from -30°C to 80°C, and an optional humidity range from 10% to 95% RH.
Stress testing is expected to be carried out on each batch of the drug substance which should include the effect of temperatures in 10°C increments (50°C, 60°C, etc.). Similarly, stress testing for humidity is typically performed at 75% RH or greater (where appropriate).
Qualification
To provide evidence of stability tests, and for the approval of pharmaceuticals, various steps must be taken to ensure that the stability test chambers function properly such as:
- The change in temperature and humidity need to remain within the chamber’s needs and specific range in order to maintain this over a relatively long period of time.
- The stability chambers should meet ICH Q1A guidelines for pharmaceutical stability testing that provide direction on stability testing agreements including temperature, humidity, and trial duration.
Validation should be carried out on a regular basis to secure that an environmental room or cabinet is fit for error free and repeatable performance.
The various steps regarding the installation qualifications for validating stability chambers are:
Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)
Many of our clients are from the Middle East, Africa and Europe, with production facilities both domestically and abroad.
Our Values
About Us
VackerGlobal is providing air engineering solutions for almost 10 years. Our products and services are available across the world including the USA, Europe, Middle East, and Africa. VackerGlobal is involved in all kinds of sensors, measuring instruments, monitoring systems, and control solutions for temperature, humidity & pressure. We are an ISO 9001:2015 & ISO 45001:2018 certified company trusted by multinational companies.
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