Reliable, Compliant, and Traceable Results
Accurate Analytical Data
Trustworthy GPC/SEC guarantees proper functioning of equipment and ensures consistently accurate analytical data. The first step to trustworthy GPC is to install and maintain traceable and well documented GPC/SEC systems.
High-tech analytical instruments can not in themselves guarantee precise and correct results, whereas users can with modern approaches, efficient user- friendly software, compliance to national & international norms and guidelines and support from experts.
PSS ensuing solutions for Trustworthy GPC/SEC systems support for all phases of the analysis from method establishment throughout the system's complete life cycle.
- Dedicated GPC/SEC concepts which have proven cost-effective and successful solutions for all steps of validation.
- Modern, self-operable procedures to verify and give transparency and traceability to the entire system.
- Support from experienced GPC/SEC specialists and DIN ISO 9001:2000 certified contract analysis to help with exceptional tasks and specialty detectors or methods.
- Method development to establish or perform measurements that are not customary at your own analytical laboratory.
Compliant System Validation
Users can order the PSS complete instrument and software qualification service, at which point, PSS executes and documents all parts of the validation from Design Qualification (DQ) to Operational Qualification (OQ); for the Performance Qualification (PQ), validation of the application itself, PSS supports you with column and method development expertise.
Alternatively, for you (the user) to execute qualification tests on-site, PSS has integrated IQ, OQ/PV and PQ hardware and software tests within the Compliance Pack module, an option for WinGPC Unity Macromolecular Chromatography Data System. The Compliance Pack module documents adherence of WinGPC software and all its modules (i.e., viscometry, light scattering, 2D chromatography etc.) to requirements of FDA, ICH and GxP.
EasyValid System Suitability Test
PSS sells a dedicated GPC/SEC system suitability test that works for any equipment configuration, independently of instrument, hardware and software configuration. The EasyValid Validation Kit is applicable for the validation of mixed and matched components or for turn-key GPC/SEC systems. The test checks the overall performance for all components under true GPC/SEC conditions, using extensively characterized reference materials, (round robin certified) to authenticate the GPC/SEC typical results.
The EasyValid kit includes reference standards, a confirmation column, detailed procedure and documentation suitable for beginners or experienced users alike.
Certified Contract Analysis
The DIN EN ISO 9001:2000 certified PSS contract analysis laboratory features comprehensive services for the characterization of macromolecules and additives, in compliance with national and international guidelines. You receive competent and fast quality control as well as method development and measurements for R&D tasks. New methods are formulated in close cooperation with the R&D department. Documentation and validation of the systems as well as reporting may be performed according to client-specific requirements, delivering results ready for use with LIMS systems or other software informatics solutions.
PSS Contract Analysis Laboratory offers the following services:
- Conventional GPC/SEC in all solvents with online and off-line hyphenated techniques
- Additive analysis
- Static and dynamic liight scattering
- Membrane analysis
- Pore size characterization
You will profit from PSS' substantial development experience, not only of methodology, but also of high performance, stable, and inert GPC/SEC stationary phases. PSS column and particle technology will address even the most demanding applications on complex macromolecular analysis.
|405-0001||EasyValid Validation Kit|
|400-0073||4.6 mm I.D. x 250 mm length (30 mm precolumn), other dimensions on request|
|400-1011||Compliance Pack for WinGPC UniChrom|
|899-0021||Instrument and Software Qualification Service|
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