News & events
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ARL’s Cleanroom
Read MoreARL’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
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Method Suitability and its Importance to the Sterility Test Method
Read MoreKerri 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
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Microbial Disinfectant Cleaning Challenge Studies
Read MoreJames 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
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Particulate Matter Testing
Read MoreCindy 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
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Benefits of Submitting Master Formulation Records
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Stability Versus Potency Testing: The Madness is in the Method
Read MoreAbstract: Potency tests, known as quantitative tests, are designed to determine how much of the active drug is in the sample. Stability tests are used to determine a beyond-use date for a preparation. Employing the proper method to determine potency or stability is key to understanding the difference between potency testing and stability testing. Methods