Water activity is broadly used and accepted in the food industry to control both product safety and quality. While for the pharmaceutical industry water activity has been well established to have the same efficacy, it has not yet been accepted as integral to a drug release program.
USP <1112> is an informational chapter on the application of water activity in pharma and has been in publication since 2006; however, it does not include an SOP or any validation guidance.
To remove this limitation, USP has developed USP <922> Water Activity as an official method for measuring water activity that will hopefully further facilitate the implementation of water activity as an integral part of a pharmaceutical quality program. Both USP <922> and USP <1112> highlight the potential applications for water activity. These include stability control, microbial risk prevention, optimized formulation reduced caking and clumping, and moisture migration control.
Learn more about water activity in Cannabis in this eLearning course that Dr. Brady Carter worked on with ASTM. It is a great way to learn more about why water activity is a required test for Cannabis in most states.
Cannabis-based products for both medicinal and recreational use are gaining in popularity and acceptance. However, if not handled properly, these products can pose a safety issue for consumers. Dried buds, extracted oils, or processed edibles with microbial contamination can result in allergic reactions, respiratory complications, or foodborne illnesses. From a quality standpoint, changes in efficacy and potency due to chemical reactions or structural loss can also result in poor product and lost revenue. Water activity is utilized as an effective tool in the food and pharmaceutical industries to maximize microbial, chemical, and physical stability. It provides this same safety and control to the cannabis market and it is important that cultivators and processors understand water activity and how to maximize its usefulness. Safety regulations for the cultivation and processing of cannabis-based products is currently handled at the state level, resulting in inconsistent recommendations. As a result, not all states currently require water activity testing of cannabis. However, based on its established relationship with common safety and quality modes of failure, it should be one of the most important analytical test run by anyone in the cannabis market.
Our Application Scientist, Dr. Brady Carter, has been interviewed by Keith Loria at Pet Food Processing magazine for their September 2020 edition.
Read the article here to learn more about why water activity measurement is so important in pet food processing and how Neutec Group can help!
By Dr. Brady Carter
The shelf life of a product is defined as the practical time that it remains desirable to consumers. It dictates the radius of distribution for the product, how it must be stored, and its best by date. Failure to match this expected shelf life can result in customer complaints, product recalls, and tarnished reputation. Consequently, correctly determining the optimal production process and handling that maximizes the shelf life and then monitoring to make sure those conditions are met is the difference between profitability and lost revenue. However, correctly determining the shelf life of a product can be a challenging endeavor, often due to a lack of resources and clear guidelines for conducting shelf life testing. The shelf life simplified paradigm takes a pragmatic approach to shelf life determination by using the relationship between water activity and shelf life to guide the process.
Our Application Scientist, Dr. Brady Carter, is an expert on water activity and moisture sorption with over 20 years of experience as a research scientist. He has presented hundreds of webinars, provided training seminars across the world on all aspects of water activity measurement and application, and has authored numerous publications including his newest chapter published Applications for Dynamic Moisture Sorption Profiles in Foods in Water Activity in Foods: Fundamentals and Applications.
With the legalization of cannabis-based products for both medicinal and in some locations recreational use, has come the need to implement safety initiatives. Microbial contamination in either dried buds, extracted oils, or processed edibles can result in allergic reactions, respiratory complications, or foodborne illnesses. In addition, breakdown due to chemical reactions can result in changes in efficacy and potency. Water activity is an effective tool used in the food and pharmaceutical industries to maximize microbial, chemical, and physical stability. It provides this same safety and control to the cannabis market and it is important that cultivators and processors understand water activity and how to maximize its usefulness.
Water Activity in pharma applications is not something new, but is often overlooked in favor of main- stream analytical laboratory technologies like HPLC, GC etc. Because there is little regulatory pressure on doing water activity measurements, this parameter is somewhat overlooked in the pharma industry. Contrary to this, demand is steadily increasing for aw testing because of the benefits it has for API (active pharmaceutical ingredients.) These include stability, low microbial risk, optimized formulation, reduced caking and clumping and low moisture migration which all have massive product improvement advantages.The resulting key benefits are: Less consumer complaints, greater confidence, higher production output with consequently better products for the consumer and greater profits for the manufacturer.Conclusively, water activity is a powerful, and often essential, quality parameter for pharmaceutical products.