News & events

Kathy Heatherly, MSFS, ARL Technical Sales A bulk substance, also known as an active pharmaceutical ingredient (API), is often the starting point of a compounded preparation.   Prior to use, compounding pharmacies and outsourcing facilities should confirm the quality of an active pharmaceutical ingredient to ensure consistency of the material as received from the supplier and suitability for use

Andrew Taylor, ARL Bio Pharma Microbiology Lab Supervisor Pyrogens are a group of fever causing substances which can be found in compounded sterile preparations (CSPs) if appropriate actions are not taken to reduce or remove them. One of the most widely known groups of pyrogens are bacterial endotoxins.  Bacterial endotoxins are: USP <797> requires a

Dr. Qiang Liu, Chief Scientific Officer A beyond use date (BUD) is the date after which a compounded preparation shall not be used. The BUD is determined from the date the preparation is compounded. This date should be based on drug-specific, scientifically valid studies when possible. Things to consider when assigning BUD include:   USP <797>

Qiang Liu, PhD, Research and Development Supervisor Container Closure Integrity Testing (CCIT) The container closure system for a drug product provides critical protection for stability and sterility. Contaminants (such as microorganisms and reactive substances) could potentially cross through defective container closures putting the drug product and patients at risk. USP chapter <1207> defines the concept of container

ARL’s sterility testing cleanroom provides reliable results to verify your people, processes, and drug products are free of contamination. This pharmaceutical grade facility has cutting edge technology that controls the sample test environment and improves the reliability of your sterility results. Our cleanroom provides you faster results in a controlled environment you can trust. Call 800-393-1595 today

Kerri Hirst, Senior Microbiologist Sterility testing by USP <71> is a test used in tandem with other sterility assurance procedures and tests to ensure that a product is free of microbial contaminants and safe for patients to use.  For a sterility test to perform appropriately, a method suitability validation must be completed on each specific