News & events

Berenice Dethier, Research Chemist II A potency test measures the amount of API in a formulation to ensure the product is within its specifications. Criteria for acceptance are set by the client and/or follow the industry benchmarks (generally set by USP). Several factors can contribute to a failing potency result.  Investigating the root cause of the failing

ARL now offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, cassettes, and vials. Three types of leaks that can be detected during CCIT include:   Historically, CCIT has been performed using probabilistic tests such as dye ingress or microbial immersion. Recently, USP issued new guidance requiring deterministic tests to achieve more

Vince Bobin, Laboratory Director Some of the same challenges in creating a formulation are also related to getting accurate and representative results from your Analytical Testing.  This article outlines how to avoid some common issues to help ensure the quality of compounded products. Topics include: Salt vs. Free Base Many pharmaceutical drugs are manufactured as

Andrew Taylor, Microbiology Supervisor Microbial identification is an important component of a quality assurance program; specifically as it relates to environmental monitoring (EM), raw material and final product bioburden assessment, and out-of-specification (OOS) investigations. Environmental Monitoring USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments states “a successful environmental control program includes an appropriate level of

Andrew Taylor, ARL Bio Pharma Microbiology Supervisor In recent years, there have been instances of endotoxin-caused illness resulting from contaminated compounded sterile preparations. In 2015, an incident occurred where seven cases of endotoxin poisoning were related to contaminated glutathione infusions. In this case, patients were symptomatic within 2 hours of administration. Most cases reported fever, rigor, and headache. An

Kerri Hirst, Microbiologist, ARL Bio Pharma A sterility test detects microbial contamination and provides data to determine if your product is ready for release.  A “Sterile” result indicates no contaminating microorganism is found in the sample. A “Not Sterile” result indicates microbial growth and the product examined does not comply with the test for sterility, unless it