Have a challenge? Bring it to Alcami! We are equipped and experienced in a broad assortment of specialty capabilities to provide solutions to your drug development process and validation challenges.
Environmental Monitoring & Cleanroom Services
A successful environmental monitoring program begins with the appropriate qualification and certification activities that will lay the groundwork for routine testing. Our team is well-versed in the current industry and regulatory standards and can assist with the state of control of manufacturing and testing environments.
Alcami is equipped and ready to handle study design and execution of food studies to support a variety of oral solid dosage forms, including tablets, capsules, and suspensions. Our subject matter experts have developed and executed studies using infant formula, yogurt, orange juice, apple sauce, smoothies, and a variety of other foods and drinks.
We offer multiple ICP-MS capabilities including catalyst control, assay determination, organometallic compounds, and cleaning verification methods in addition to elemental impurities testing (raw material and product testing).
Extractables & Leachables
Our scientists have a thorough working knowledge of plastics, rubber, and elastomeric materials - compounds frequently used in pharmaceutical manufacturing, packaging, and delivery technologies. Equipped with a wide range of compliant qualified instrumentation and working under cGMP guidelines, we perform timely, efficient trace analysis necessary to support your applications.
Alcami has the experience, technology, and testing platform to assist at all stages of nitrosamine assessments. There are 2 phases to nitrosamine compliance: assessment and testing.
Alcami specializes in Category 1 syringeability studies, has full GMP traceability, and uses a team-based approach when applying appropriate resources to effectively meet client deadlines. This is especially important as Category 1 strategies and results drive the in-vivo Category 2 and 3 studies required for abuse-deterrent labeling of drug products.
Rapid sterility is an alternative microbiological test method to the US Pharmacopeia (USP) <71>, Ph. Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. Alcami utilizes the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.
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