Application and importance of water activity in pharmaceutical factories
The application and importance of water activity to pharmaceutical factories | Tengyi Technology
Why is water activity important?
"Water activity" refers to the free-flowing water content in a product. It is closely related to the activity of microorganisms and the chemical stability of substances. It is a key parameter for controlling the "shelf life" and "quality" of products. The water activity analyzer is mainly used to reflect the effective moisture, stability and microbial growth status of food in a balanced state, as well as the chemical, enzymatic and physical changes that can affect food quality. It is often used to measure the ability of microorganisms to tolerate dryness. By measuring the water activity index of food and choosing reasonable packaging and storage methods, the use of preservatives can be reduced and the shelf life of food and fruits and vegetables can be determined. Since yeast, mold and bacteria need sufficient water to maintain growth, the water activity of various foods must be lower than the standard to effectively control the growth of microorganisms.
On March 30, 2018, the United States Pharmacopeia (USP) published a notice regarding new regulations related to water activity. The measurement of water activity has been incorporated into the regulations of the United States Pharmacopoeia and has officially become one of the necessary links in the pharmaceutical manufacturing process in the United States. It is believed that in the near future in Taiwan, water activity testing will be included in the Taiwan Pharmacopoeia regulations. Therefore, pharmaceutical manufacturers must begin to pay attention to the importance of water activity.
For more information, please visit: https://www.gmp-compliance.org/gmp-news/new-usp-chapter-922-water-activity
2. How to detect water activity?
a. List of types of water activity test analyzers:
- Electronic hygrometer (resistance hygrometer/capacitance hygrometer)
Humidity measurement (wet bulb temperature)
Dew point (cold mirror hygrometer/thermocouple)
Hair hygrometer
Freezing point depression sensor
Near infrared spectroscopy
b. List of necessary operations and calibrations for water activity test analyzers:
Standard saturated salt solution
Calibration of water activity meter (dew point hygrometer/electronic hygrometer/near infrared spectroscopy)
Precision/repeatability evaluation (performance qualification)
Water activity measurement (sample preparation/calibration check/measurement procedure/reporting results)
Freund, Japan, provides quality reports (IQ&OQ) for pharmaceutical customers for water activity test analyzers. Tengyi Technology is the exclusive agent of FREUND in Taiwan. Welcome to refer to us.
If you want to arrange a demonstration, please contact: 02-7746-3341
