Specialty Capabilities
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.
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Food Interaction
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.
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ICP-MS Capabilities
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).
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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.
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Nitrosamines
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.
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Abuse Deterrence
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.
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Rapid Sterility
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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