Our Services
- Extractable / Leachable Testing
- Chemical Compatibility Testing of Filters
- Validation and Auditable Analytical Testing Services
- USP Testing
- Validation Consulting
- Method Development and Validation
- Long Term Stability Testing
- Controlled Substance Handling
- Auditing Services for FDA/EPA Regulated Environments
Extractable / Leachable Testing
With the FDA's increasing concern about leachables from plastic and rubber materials used to produce final drug formulations, having the appropriate testing methods is critical to FDA approval. Validation Resources, LLC has developed the science of detecting, identifying, and quantitating extractables and leachables. Take advantage of this experience and let Validation Resources guide you through the testing process.
Chemical Compatibility Testing of Filters
Validation Resources is able to perform Chemical Compatibility testing of filters. These services include Bubble Point Comparison, Flow Rate Comparison, Burst Pressure Comparison, and Membrane Thickness Comparison.
Validation and Auditable Analytical Testing Services
All of our testing is auditable. The process begins with the creation of a customer approved protocol designed for a specific application. The end result is a customer approved final report.
During the test each step is well documented following controlled procedures, data is generated using qualified equipment and methods, the data verified and materials tracked. Testing services include, but are not limited to, qualitative and quantitative studies.
USP Testing
We are able to perform a variety of USP testing including, but not limited to:
- Residual Solvents - USP <467>
- Nonvolatile Residue (NVR) - USP <661>
- Water Conductivity - USP <645>
- pH - USP <791>
- pH - USP (Sterile Purified Water)
- Total Organic Carbon (TOC) - USP <643>
- Ammonia - USP (Sterile Purified Water)
- Calcium - USP (Sterile Purified Water)
- Carbon Dioxide - USP (Sterile Purified Water)
- Chloride - USP (Sterile Purified Water)
- Sulfate - USP (Sterile Purified Water)
- Oxidizable Substances - USP (Sterile Purified Water)
- Heavy Metals - USP <231>
- Karl Fischer - USP <921>
Validation Consulting
Validation Resources, LLC is at the forefront of current scientific and regulatory issues regarding extractables and leachables. Our scientists have presented papers and served as session moderators at PDA extractables symposia as well as annual PDA meetings. We can give your materials validation program the direction that it needs to meet the current regulatory requirements.
Method Development and Validation
We can develop and validate your analytical methods.
Long Term Stability Testing
We are able to provide long-term stability testing at controlled temperature.
Controlled Substance Handling
Validation Resources has an active DEA Controlled Substance Registration for Schedules 2, 3, 3N, 4, and 5.
Auditing Services for FDA/EPA Regulated Environments
- Independent, external audits of quality systems
- Supplier Audits
- Contract laboratory audits
- Contract manufacturer audits