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Pharmaceutical

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Infinity Laboratories has been helping the pharmaceutical industry assure the safety and efficacy of drug products for over two decades. By offering a full suite of analytical testing services for raw materials, in-process materials, and finished products, Infinity can help you to ensure regulatory compliance while also reducing risk and time to market.

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Pharmaceutical Testing Services

Our team of seasoned life science professionals act as an extension of your team with comprehensive testing, method development, and validation services for traditional and novel drug products.

Infinity supports the entire product lifecycle with single-source testing services including:
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Method Development & Regulatory Support

With decades of experience in contract laboratory testing, Infinity has the expertise to construct phase-appropriate analytical methods and quality data for every step of your product’s journey.

Analytical Chemistry Testing

Comprehensive method development, validation, and analytical testing services nationwide for traditional and advanced pharmaceutical organizations.

Wet Chemistry Testing

Infinity provides precise results and reliable data through a set of traditional assays characterizing elements in a liquefied sample.

Stability Testing

Validate that your product maintains the characteristics demonstrated at the point of manufacture throughout warehousing, transportation, storage, and administration.

Microbiology Testing

Comprehensive microbiological testing to support identifying and eliminating potential contamination risks by specific pathogens, bacteria, yeast, and molds.

Sterility Assurance Testing

Comprehensive sterility monitoring and validation to support the safety of your therapeutics.

Gas & Water Testing

Ensure product safety and quality by identifying contamination, impurities, or lack of consistency in your gas and water supplies.

Extractables & Leachables Studies

Identify potentially harmful contamination of your drug product, identifying any undesirable effects of extractables and leachables.

Container Testing

Ensure your container is suitable for direct contact with your drug product during its distribution and shelf-life through various compatibility and material assays.

Package Testing

Safeguard your pharmaceutical product from the harsh conditions of real-world distribution to assure safe delivery through package and environmental testing.

Sterilization, Cleanroom & Instrumentation Services

Just as Infinity’s testing services support drug product development, quality, and safety from early-phase development to commercialization, our cleanroom, environmental monitoring, and instrumentation services allow for effective and compliant operations.

Infinity provides robust product and facility services to support the entire development process, including:
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EO Sterilization

Effective sterilization for single-use bioprocessing systems and other therapeutic production materials using cutting-edge technologies.

Cleanroom Validation & Certification Services

Validate that the air supply, air distribution, filtration, materials, and procedures are regulated to meet the relevant parameters as defined by ISO 14698.

Environmental Monitoring

Our team studies for contamination continuously, developing monitoring programs that ensure compliance with FDA, USP, ISO 13485, and ISO 14698 requirements.

Laboratory & Process Instrumentation Services

Infinity supports a wide range of laboratory instruments for our pharmaceutical partners, including calibration, repair, and maintenance.
“At Infinity, we provide the capabilities and service offerings of a national organization, with the flexibility of a local lab. It’s really important to us to maintain a personal connection with our clients as we continue to fulfill our vision of becoming a single source testing services provider for the pharmaceutical, medical device, and compounding pharmacy sectors.”
Joe Troxell, CEO at Infinity Laboratories

Get in Touch

Want to learn more about our analytical, sterilization, cleanroom, and laboratory instrumentation services for pharmaceutical developers and manufacturers? Connect with one of our team members today.

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