Specialty Solutions for Trustworthy GPC Results
PSS ensuing solutions for Trustworthy GPC/SEC support all phases of the analysis from method establishment through the system’s complete life cycle:
- Complete instrument and software qualification service; PSS executes and documents all parts of the validation from DQ to OQ; for the PQ, validation of the application itself, PSS supports you with column and method development expertise
- Software and Modules; Execute all the validation steps yourself in-house: IQ, OQ/PV and PQ hardware and software tests are integrated within the Compliance Pack module, an option module for WingGPC Unity Macromolecular Chromatography Data System
- Tools: EasyValid Validation Kit; with self-operable procedures to verify, give transparency and traceability to the entire system. PSS’ system suitability test checks the performance of any GPC/SEC equipment, even if configured with mix and match components, under true GPC/SEC conditionsy
- Certified Contract Analysis (DIN EN ISO 9001:2000) You receive competent and fast quality control, method development or/and measurements for R&D tasks. Documentation and validation of the systems and reporting may be performed according to client-specific requirements, delivering results ready for use with LIMS systems or other software informatics solutionss.
- Turn-key Instrumentation SECcurity GPC System with personalized configuration, support and training
Method Development for Macromolecular Characterization
PSS is committed to work with you on various aspects of methods development:
- Evaluate & document a column selection
- Trial testing of a particular polymer to validate other analytical testing services prior to analytical outsourcing of your samples
- Complex protocol development under GMP/GLP requirements /methodologies typical of the pharmaceutical industry
- To demonstrate Method Robustness.
Evaluate and Document a Column Selection
PSS will facilitate your column selection when you are researching alternative GPC columns or your new product has not been subject of a PSS application. Subject to pre-approval, PSS will select a suitable stationary phase and perform a GPC test to document our columns performance with your own samples. We will process the sample through the analytical service lab charging the customary testing fee. The cost of this service will be credited to the purchase of the column set used for the test (especified in the analysis report).
Trial Testing Prior to Analytical Outsourcing
Subject to pre-approval, PSS will perform a trial testing for you to decide if the prescribed GPC test and conditions are adequate for your testing needs We will analyze the sample(s) and charge the customary testing fee. The cost of this test will be credited to offset the cost of testing your sample batch at our laboratory, using the same methodology of the testing trial.
GMP/GLP or Method Robustness Protocol Development
Complex protocol development for research or to document GMP/GLP methods, will be assessed to cover the hourly cost of development and quoted separately.
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