Compounding Pharmacy

Infinity Laboratories supports compounding pharmacies with state-of-the-art facilities across the United States. Acting as an extension of your team, we deliver quality results with the rapid turnaround time of a local lab while utilizing the cutting-edge solutions of a national provider.

We offer comprehensive analytical testing services for raw materials, in-process materials, finished products, containers, and packaging. Additionally, cleanroom, EO sterilization, and laboratory instrumentation services ensure your compounding facility is compliant, safe, and efficient.

Compounding Pharmacy Testing Services

Compounding pharmaceutical organizations operate under the same rigor as any drug or device manufacturing operation. However, they also face the challenge of maintaining the nimble operations needed for small-batch, customized drug, or medical device production.

Infinity offers thousands of US-based compounding pharmacies robust testing services that include:
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Method Development & Regulatory Support

With decades of experience in contract testing, Infinity has the experience to construct phase-appropriate analytical methods and quality data for your compounding pharmacy.

Analytical Chemistry Testing

Comprehensive method development, validation, and analytical testing services for compounding pharmacies nationwide.

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 production 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 drug or medical device product.

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 or medical device product, identifying any undesirable effects of extractables and leachables.

Container Testing

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

Package Testing

Safeguard your drug or medical device 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 and medical device product development, quality, and safety from development to commercialization, our cleanroom, environmental monitoring, and instrumentation services allow for effective and compliant compounding pharmacy operations.

Infinity provide full-service sterilization and equipment support services that include:
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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 compounding pharmacy 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 compounding pharmacies? Connect with one of our team members today.