CS Analytical is the only FDA Regulated, cGMP contract laboratory that is solely dedicated to issues specific to container and package system qualification testing. The CS Analytical team is committed to helping clients ensure all container and package system regulatory requirements are met. This All-Star team of package professionals have the knowledge and experience across a wide variety of package types and services.
Ronak Patel: Manager, Routine Container Testing
A laboratory chemist with over ten years of experience in the contract laboratory market, Ronak also holds a Master of Business Administration degree. Ronak manages all aspects of CS Analytical routine container testing programs and is an expert in ICP-MS analytical techniques specific to USP 661.1, USP 232 and USP 233 Elemental Impurities, and more. Key areas of expertise include:
- USP 661.1 and USP 661.2
- USP 661 Plastic Testing
- USP 381 Elastomeric Closures
- USP 660 Glass Testing
- All relevant EP container and package system procedures
- Instrumental Analysis to include FT-IR, DSC, TOC, UV-Vis, ICP-MS
Alanna Johnson: Manager, Container Closure Integrity Testing
A highly experienced analyst and manager for all aspects of USP 1207 Container Closure Integrity Testing, Alanna holds a degree in Environmental Sciences. She plays a key role in all aspects of CS Analytical container leak testing programs inclusive of comprehensive CCI strategy development, method selection, test method development and validation, and overall study execution. She is an expert in all deterministic USP 1207 technologies including:
- USP 1207 Laser-Based Headspace Analysis
- USP 1207 Vacuum Decay Testing
- USP 1207 High Voltage Leak Testing
- USP 1207 Helium Leak Testing
Eric Creveling: Manager, Complementary & Comprehensive Services
A highly experienced laboratory professional, Eric brings more than 15 years of experience with a wide array of unique test requirements for container and package systems. Eric has experience and first-hand knowledge of virtually every type of package system that can or has been used for pharma, biotech, and medical device products. He is an expert in many test procedures that complement USP / EP requirements and works effectively across the CS Analytical team to implement comprehensive test programs to ensure a package system meets all relevant requirements. These programs provide value across the product lifecycle, from package development, validation, manufacturing in-process controls, and stability. Keys area of service that he oversees include:
- ASTM D4169 & ISTA Distribution Testing
- ASTM Bubble Emission, Dye Penetration, and Seal Quality Tests
- Instron Functional Testing inclusive of Method Development and Validation
- ISO Syringe Testing
- Storage, Stability, and Accelerated Aging Programs
- Volume Verification / Dose Accuracy Testing
- Packaging Component Dimensional Analysis
At CS Analytical, we take great pride in helping clients bring their products from concept, through FDA approval, and to market for patient use. Our team of package system experts understand the regulatory process and challenges that clients face, and we are committed to using our knowledge and experience to help clients work through the process in an straightforward and seamless manner.
