PTL’s analytical team is your expert choice for the comprehensive development and validation of dependable particle characterization test methods. Our extensive experience with a wide variety of material types, industries, and analytical techniques provides a broad knowledge base to facilitate the development and validation of accurate, robust, and precise methods for even the most problematic sample types.
Method Development (Stage 1 & Stage 2) – NEW Method
PTL utilizes a two-stage method development system, depending on how robust our clients desire their method to be. Stage 1 establishes basic method parameters and proof-of-concept; no prior method is needed to start. Stage 2 includes a customized design-of-experiments testing plan by our statistical team in order to evaluate multiple factors and their potential to impact results. Refinement of critical factors may ensue, in order to assure that variances are minimized in the final method.
Clients receive a comprehensive method development report which includes all initial evaluations conducted, corresponding results, statistical summaries, as well as the finalized test method. Contact PTL today to discuss your method development needs.
Method Evaluation
Since our clients come from a wide variety of backgrounds and process stages, PTL also conducts preliminary evaluation of partial or full client-provided test methods. Cursory analytical support time allows for us to assess whether your method would benefit from deeper development or is already close to being prepared for validation. This evaluation aims to conclude with a formally incepted PTL test method, ready for Stage 2 development or validation.
Method Validation
PTL’s validation team has broad and extensive experience conducting particle characterization validations at client request. Method validations are conducted in conjunction with PTL developed methods or client provided methods. PTL follows testing guidelines set forth by the ICH, USP, and FDA.
As your validation partner, PTL customizes a testing protocol designed per your specific quality requirements. At the conclusion of testing, PTL provides a comprehensive validation report which incorporates the validation data and statistical summary, as well as the final validated method. Contact PTL’s validation team today to discuss your validation requirements.
Method Verification
PTL frequently conducts method verifications for our clients, following USP guidelines. PTL provides a complete verification package, including protocol development, sample analysis, and a comprehensive report. Contact PTL’s validation team to discuss your specific method verification requirements.
Method Transfer
PTL coordinates and executes method transfer projects both into PTL’s laboratory as well as those transferred to an alternative facility. Whether your company requires complete oversight of the project, including protocol creation, testing, and report generation, or simply execution of the analytical testing in accordance with your provided protocol, PTL is prepared to participate at any level. Throughout the method transfer process, PTL will work to assure your quality requirement