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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.
contact us for
more info.
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