Centralized laboratory specializing in cleaning development studies & associated analytical services.

Hyde's C.O.R.E. Lab

Hyde’s CORE Lab is our centralized laboratory specializing in cleaning development studies and associated analytical services. As a solutions oriented partner in the development and maintenance of your cleaning systems, we optimize your cleaning program to ensure FDA compliance, minimal downtime and efficient product and equipment groupings. By using Quality by Design (QbD) principles, our team provides incremental improvement

- Cost Reduction
Specialized skills, efficient execution

- Optimization
Comprehensive, impartial with continued process verification

- Regulatory Compliance
FDA, ICH, PDA, ISPE, ASTM alignment

- Exploration
Quality by Design (QbD), 6 Sigma principles

Hyde’s CORE Lab partners with our clients to optimize cleaning programs using robust data-driven methodologies. Our science-based studies ensure regulatory compliance aligning with international guidance and industry best practices

  • Cleaning Development
  • Analytical Methods (TOC Swab/Rinse Recovery)
  • Pilot Scale Studies

Cleaning Agent Screening & Selection Determination of the most viable cleaning agent (alkaline, neutral or acidic) and assessment of the most suitable chemical for the particular residue.
“Worst–Case” Residue Determination Using fixed parameters of temperature, cleaning agent concentration, and agitation determined from conversations with the client, multiple residues are evaluated to determine the one that is most difficult to remove under worst-case conditions.
Design Space Exploration With the identified worst-case residue and cleaning agent in hand, the design space exploration uses a Design of Experiments (DOE) approach to explore the interdependency between temperature, chemical concentration and mechanical agitation. The design space exploration allows for a selection of optimal cleaning parameters that can be scaled up to pilot and production processes.
Visual Residue Limit Studies Visual residue limits (VRL) represent a simple alternative to analytical methods used for cleaning verification and requalification. Hyde will explore decreasing amounts of process residue under controlled conditions with multiple operators to assess if the VRL is more or less than the Acceptable Residue Limit of detection. chemical for the particular residue.
Surface Swab Method Development In order to comply with FDA guidelines on direct surface sampling, Hyde will develop a swab method specific to the client’s worst-case compound for Total Organic Carbon (TOC) analysis.
TOC Method Validation Using the worst-case residue, Hyde will validate swab and rinse methods using Total Organic Carbon (TOC) as the analytical tool. Once complete, the method can easily be transferred to the client’s laboratory through an evaluation of accuracy (recovery) against the method validation results.
Pilot Scale Testing With the laboratory results in hand, process parameters are scaled up to a pilot level to assess the most suitable cleaning duration based on the selected temperature, chemical agent type and concentration, and flow velocity.
Custom Design of Experiments (DOE) Other critical cleaning parameters can be evaluated within a DOE framework to better optimize the cleaning process. Potential variables for exploration include temperature, cleaning agent concentration, cleaning agent type, agitation and materials of construction.curacy (recovery) against the method validation results.