News & events

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

James Zellner, ARL Bio Pharma Technical Sales How do you know your staff is doing a thorough job disinfecting surfaces and equipment at your facility?  Do you have proof that your cleaning procedure is effective in removing potential contaminants from surface areas? An important part of a complete quality program is generating data that the

Cindy Pickens, ARL Bio Pharma Laboratory Supervisor Particulate Matter testing is performed on all parenteral solutions to determine the cleanliness and stability of the solution; and, is listed in USP <797> as a necessary component for quality assurance of compounded sterile preparations under the responsibilities of compounding personnel. It is also specifically outlined as a