wingpc mcds - comprehensive software for ... - pss-polymer.com€¦ · polymer standards _____ 15...

WinGPC UniChromMCDS

WinGPC UniChrom 3 2 PSS Perfect Separation Solutions

PSS About us Content

Why WinGPC UniChrom?One Chromatography Data System for the analysis of (Bio)Polymers and Proteins _______________ 4User friendly, precise, accurate and inspired __ 5

One solution from single user data im-port to client/serverData Evaluation ____________________________ 6(Multi)Workstation _________________________ 7Client/server solutions _____________________ 7

Compliant and validatedComprehensive data security and compliance _ 8UniChrom Compliance Pack _________________ 9

Powerful Software Modules forintelligent Copolymer Analysis ______________ 10

2D-Chromatography module ____________ 11Chemical Heterogeneity module _________ 11Copolymer analysis module ______________ 113D Spectra module _____________________ 11

Powerful Software Modules forabsolute molar masses and structure determination ____________________ 12

Light scattering modules ________________ 13Viscosity module _______________________ 13Mass spectrometry module ______________ 13End group analysis module ______________ 13

Reporting is a BreezeWinGPC UniChrom Reporting _______________ 14Individual design of reports _________________ 14

Supplies and Services for Comprehen-sive Characterization of Natural and Synthetic Macromolecules Polymer Standards _________________________ 15GPC/SEC Columns __________________________ 15Software __________________________________ 15Systems and Detectors _____________________ 15Analytical Services _________________________ 15GPC/SEC Training and Support ______________ 15

PERFECT SEPARATION SOLUTIONS

We take care of your analytical challen-ges in Liquid Chromatography of (Bio)Polymers and Proteins:We at PSS are fully dedicated to the advancement of macromolecular liquid chromatography by means of developing true solutions and providing expert and personal support. Based on excellent products and current research in material science, we crea-te easy-to-use and powerful solutions for QC and R&D.

PSS Polymer Standards Service GmbH was founded in 1985 as a spin-off from the University of Mainz, Germany. In 2001 PSS moved to new headquarters in Mainz-Mombach. The subsidiary company, PSS-USA, opened its office in 1994 and serves North and South American customers from Amherst, Massachusetts. Additional technical offices have also been opened in The Netherlands and North-east Germany. Elsewhere, PSS works with distri-bution partners on a worldwide basis. Our clients today includes global corporations, universities, research institutes, petrochemical and pharmaceu-tical companies in more than 60 countries.

Certified DIN ISO EN 9001

PSS is DIN ISO EN 9001 certified to produce and supply high quality Reference Polymers, GPC/SEC Columns, Software and Systems for the characterization of polymers by their molecular weight and their structural characteristics.

PSS operates a manufacturing facility equipped with a state-of-the-art characterization laboratory at the headquarters in Mainz (Germany), fully sup-porting customers working under stringent regula-tory conditions e.g., GLP, DIN, ISO.

Benefit from the unique know-how and extraordi-nary services of our company.


Video: WinGPC

Why WinGPCUniChrom?

BENEFIT FROM THE ADVANTAGES OF A CDS SPECIFICALLY DEVELO-PED FOR THE COMPREHENSIVE ANALYSIS OF MACROMOLECULES

Control for LC modules of all major vendors and specialty GPC/SEC detectors WinGPC UniChrom’s wide-ranging compatibility lets you acquire data from any commercial system in the market, allowing you to capitalize on previ-ous instrumentation investments. WinGPC allows simultaneous control of multiple instruments and detectors based on RC.Net driver technology. The ChromPilot adds comprehensive and convenient system control for > 300 LC modules and GPC/SEC specialty detectors. Mixed systems and configura-tions are fully supported. For older components, PSS data acquisition hardware enables data acqui-sition from any LC instrument with analog signal outputs.

A future-proof solution eliminates the need to learn multiple programs WinGPC combines GPC/SEC/GFC and all IPC met-hods with HPLC/CE/GC quantification in one en-vironment. The modular software design fits changing needs by offering a complete path for expansion to hyphenated techniques such as light scattering, viscometry or mass spectrometry and/or to 2-dimensional separations. No longer is there a need to learn multiple programs to fully imple-ment macromolecular chromatography within the laboratory.

Effective and efficient use of all resourcesWinGPC reliably performs all analysis in the labo-ratory, saves time, and reduces operating costs. Whether you measure, evaluate, assess, validate or create reports - all instruments, methods and tasks are unified in one software environment. Time and cost savings will result in a more efficient allocation of all resources, resulting in higher lab productivity. One software to learn, validate and maintain.

ONE CHROMATOGRAPHY DATA SYSTEM FOR THE ANALYSIS OF (BIO)POLY-MERS AND PROTEINS

For all markets - for R&D and QC

Unique Solutions

user friendly precise and accurate inspired

Intuitive operationClear and user-friendlyA simplified interface always lets you see what is going on. WinGPC‘s Bird‘s-eye-view shows all import-ant parameters and results simul-taneously. All windows are continu-ously updated in real time. WinGPC lets you monitor multiple injections at the same time assuring complete method documentation and tracea-bility. In addition, it offers unlimi-ted data acquisition time as well as sample prioritarization. Intelligent batch processing accelerates data analysis. WinGPC wizards offer a step-by-step guide for non-routine tasks.

Reliable automationFor more freedom in the labRoutine tasks in QC or R&D are per-formed automatically by WinGPC UniChrom. Automation includes (re)calibration, (advanced) data eva-luation and subsequent transfer to LIMS.

Save time and solventEnhance the productivity with-out sacrificing the resolutionWinGPC UniChrom’s overlaid injec-tion feature saves about 35% time (and eluent) per injection without sacrificing resolution. Overlaid in-jection allows injection of a sample prior to completion of the previous run.

More than just numbers Precise and accurate resultsUnique algorithms, specialized software modules, comparison overlays, and dedicated tools pro-vide versatility and eliminate the need for spreadsheet calculations. WinGPC UniChrom provides tracea-ble and validated results, even for special applications. WinGPC Uni-Chrom automatically determines the measurement uncertainty for all results, taking into account the system status and the data and ca-libration quality. The Artificial Intel-ligence Engine (AI) identifies poten-tial for improvements.

Expert supportNot just for WinGPCContinuing support from the ex-perts at PSS is not limited to soft-ware installation. On-site installa-tion and training, special update or application training, regular news-letters with tips & tricks, an ap-plication database, and personal contact are all part of our service. In addition, PSS offers customized programming developed in close cooperation with our customers.

• A detailed description of the software features, the supported methods and de-tectors can be found at: www.pss-polymer.com

• Demo at your Desk - contact: [email protected]

• Watch WinGPC Videos in our Webinar Channel (follow QR-Code above): https://www.pss-polymer.com/de/support/software-support.html


Client/ServerData Evaluation MultiWorkstationOne solution from single user data import to client/server

MultiWorkstationOne software package fulfills all needs for the li-quid chromatography of polymers, biopolymers and proteins. With its unique features and soft-ware modules for the determination of absolute molecular weight and structure as well as copoly-mer analysis, it provides true solutions for QA and R&D.

A WinGPC MultiWorkstation can operate up to 4 systems. When adding new systems or features, WinGPC offers cost-effective, quick-to-install licen-se options without time-consuming (re)qualificati-ons.

The WinGPC ChromPilot makes manufacturer-in-dependent system control more universal than ever. The ChromPilot Instrument Manager shows all status information and module settings with end conditions for system shut-down at the end of the sequence. The powerful sequence manager not only organizes injections; it can also manage Inst-rument and WinGPC methods for fully automated processing. This includes changes of the method, the UV wavelength and more. Detailed instrument log books ensure complete traceability.

Client/ServerWinGPC client/server installations reduce administ-rative effort and costs to a minimum and maximize data security and traceability.

NetConnect, the software solution for company-wide installations, organizes access to all resources and, together with WinGPC, manages all systems, users and PCs with flexibility.

Users are able to have individual measurement con-figurations and can start, check and evaluate mea-surements from any PC in the network. All WinGPC MultiWorkstation software modules and evaluation options are also available for client/server installa-tions.

A SOFTWARE PIONEER WITH GROWTH PERSPECTIVE

Since 1988 – and into the future

FROM DATA IMPORT TO (MULTI) WORKSTATION TO CLIENT/SERVER SOLUTIONS

WinGPC UniChrom is the ideal solution for all labo-ratories: The flexible design fits your changing needs by of-fering a complete path for expansion. A single-user software with data import can become a (multi)workstation solution with multi-detection and multiple systems - expandable to a global client/server installation.

Data Evaluation WinGPC Data Evaluation enables correct, feature-rich, and user-friendly GPC/SEC/GFC calculations with a software package specifically developed for analysis of macromolecular distributions.

A convenient interface allows existing CDS data to be loaded into the proven WinGPC structure. WinGPC features are available for post acquisition analysis. Software modules, such as the heparin mo-dule, can be added separately.

Also available as WinGPC Portable for Data EvaluationEasy to use:just plug a USB stick into any PC or notebook and get started

IaaS solutions


Comprehensive data security and compliance

DATA SECURITY AND TRACEABILI-TY HAVE HIGHEST PRIORITY FOR THE DEVELOPMENT OF WINGPC

The sophisticated design of WinGPC’s powerful database forms the basis for solid and unique so-lutions

• All results are immediately available. • Evaluation and calibration parameters are

stored with the raw data.• No tedious searching: powerful filter functi-

ons for quick access to even the oldest data from previous versions eliminate the need to search in laboratory notebooks.

• No accidental overwriting of data: raw data are always protected - and for highest demands in combination with the Compliance Pack: data storage in the WinGPC Data Safe is available.

Compliance with national and international GPC/SEC standards (such as ISO/EN, DIN, ASTM or JIS and BR) is included in WinGPC. Built-in system sui-tability and column performance routines allow for easy-to-use tests with comprehensive docu-mentation. The optional user-friendly Compliance Pack enables users to completely fulfil the requi-rements of GxP and FDA 21CFR 11.

ValidiationWinGPC UniChrom is a commercial off-the-shelf chromatography program and a closed system. It is designed in such a way that the installed product is always identical. The user-accessible functionali-ty is controlled by a license key. This allows general validation and verification tools to be directly exe-cuted by the user on-site.

PSS has developed AUTOVAL to prove the correct-ness of WinGPC data treatment and calculation routines. This tool uses additional theoretical mo-lar mass distributions to validate software algo-rithms and data flow paths. AUTOVAL is provided free of charge with every license. The validation can be executed on any customer workstation to prove correct operation on specific systems.

Compliance Pack

WinGPC UniChrom is designed in accordance with FDA 21CFR11 to provide the necessary tools to help companies using macromolecular chromatography to comply with this rule.

Secure LoginSecure login is guaranteed using unique usernames and passwords. Direct link to the Windows Active Directory authentication protocol ensures a secure login in accordance with company policy.

Administration and User LevelsThe Compliance Pack administration tool ena-bles user administration, assignment to a specific user group as well as granting specific WinGPC ad-ministrative and operative privileges.WinGPC UniChrom offers four different user groups with pre-configured privileges recommended by PSS. To ensure efficient processing of laboratory tasks, administrators can adjust default group pri-vileges to reflect the company requirements.

Data SafeTo protect data in the Windows environment, they can be stored in the optional WinGPC Data Safe. These data can only be seen and opened in WinGPC.

Electronic SignaturesEvaluations can be electronically signed by users in a multi-step process with signing and reviewing. Electronically signed data are protected against changes.

Traceability with Logbooks and Audit TrailsFour different logbooks and audit trails independ-ently record operator actions:

• WinGPC Sample AuditTrail • WinGPC Session- Logbook • WinGPC ChromPilot System Logbook • WinGPC Administration-Logbook

Logbook and Audit Trail entries are time-stamped. They document user, workstation, action, actual value, previous value (if applicable), and, if requi-red, the reason for change.

Audit trails are encrypted, only accessible in WinGPC and cannot be edited or modified. Filter functions facilitate the audit trail review and help to identify questionable actions.

MEETS ALL COMPLI-ANCE REQUIREMENTS OF THE PHARMACEU-TICAL INDUSTRY

Precision calculation for all results including AI evaluation

2009

First version Compliance Pack for 21CFR11 requirements

2006

Data Safe for the highest level of data security at Windows level

2020

Extended options for electronic signatures

2018

ChromPilot for driver-based, vendor-independent system control

2011

First version for Windows, already with the powerful WinGPC sample database

1992


Powerful Software Modules for intelligent Copolymer Analysis

Product deformulation by applying detector or method combinationsMany samples are copolymers which have a como-nomer distribution and a molar mass distribution. The chemical heterogeneity of a product can be an important parameter for performance and quality.

WinGPC UniChrom offers a variety of data analysis options to meet any R&D and QA requirement for modern high-tech products. Access the full range of product properties through WinGPC UniChrom’s ad-vanced and unique characterization modules.

WinGPC UniChrom is the only software that seam-lessly integrates any method and detector. Data can be processed/reprocessed on-line or post-run by se-lecting the most appropriate data analysis method or method combination. This gives access to a we-alth of product properties which are not currently available in any other software.

2D CHROMATOGRAPHY MODULEThe 2D analysis module combines the separation power of two different chromatographic techni-ques (HPLC, GPC/SEC, TREF, IC, CE, GC). This results in an unmatched enhancement of resolution and peak capacity, and yields in-depth information on complex products. All kinds of detectors can be used in both dimensions. Data acquisition and con-trol of the fraction transfer between dimensions is fully automated.

Multiple views of raw and consolidated data, inclu-ding 3D surface plots or contour maps, are available.

WinGPC UniChrom is the only software that deter-mines and quantifies multiple property distributions simultaneously.

CHEMICAL HETEROGENEITY MODULEThe chemical heterogeneity module calculates the chemical composition, the skew, and width of the compositional distribution based on HPLC-type se-parations (IPC, Polymer-LAC, GPEC). It relies on a composition calibration of the chromatographical time base. This calibration can be done either with standards of known composition or by using multi-detection (Copolymer Analysis module).

COPOLYMER ANALYSIS MODULEThe copolymer analysis module calculates the ave-rage chemical composition, the comonomer dis-tribution, and the copolymer average molecular weight. It uses multiple detectors in GPC/SEC se-parations. This data processing method needs at least two independent concentration signals for the automatic determination of the copolymer composition. It relies on the calibration of the in-dividual signal responses to measure comonomer concentration in an absolute way.

3D SPECTRA MODULEThe 3D spectra module enables comprehensive analysis and display of 3D DAD/FLD data fields. It allows simultaneous data acquisition from 2D (e.g. RI, MALLS) and 3D signal sources (e.g. diode array detector DAD/PDA or fluorescence detector, FLD). After the analysis, a complete UV/VIS or FLD spec-trum with automatic assignment and interpolation of 3D data fields is displayed.

This module requires the ChromPilot for system control.


Powerful Software Modules for absolute molar masses and structure determination

Determine true molar masses and more with advanced detectionThe characterization of modern and highly specia-lized macromolecules is challenging due to the va-riety of monomers and topologies. The macromo-lecular architecture strongly affects the application properties with respect to processability, rheologi-cal behavior and transport properties.

GPC/SEC elucidation of these products has become more feasible with the availability of on-line mass spectrometers and molar mass sensitive detectors like light scattering or viscometers. They provide absolute molecular weights, the type of branching architecture and the degree of branching. The addi-tion of light scattering and viscometry information

adds reliability and significance by combining prima-ry information. The use of viscometry in conjunction with RALLS (Triple Detection) has become standard methodology to overcome the limitation posed by 90° light scattering. The combination of the LS mo-dule and the viscosity module adds triple evaluation capability. WinGPC UniChrom goes one step further by combining MALLS and/or viscometry with mass spectrometry and end group analysis. This allows for the unambiguous absolute measurement of bran-ching, aggregation, agglomeration, structure para-meters and gel content.

LIGHT SCATTERING MODULESWinGPC supports all light scattering methods and a large selection of detectors. Two static light scat-tering modules are available, which differ in the number of supported angles and are therefore tailored to your application. Both modules also support dynamic light scattering for the display of hydrodynamic radii.

For applications that can be restricted to a single angle, the LS module is the suitable choice for any RALLS or LALLS instrument. Validated light scat-tering data evaluation yields absolute and reliable measurement of all molar mass averages and their distribution, including dn/dc or recovery determi-nation. The MALLS module has all the single angle features as well as the following additional information: ra-dius of gyration (Rg) and its distribution evaluated with Zimm’s, Debye’s or Berry’s method, degree of branching and structure coefficients. WinGPC UniChrom allows monitoring of up to 20 different angles and 6 auxiliary analog signals from RI, UV, pressure or viscometer at the same time.

VISCOSITY MODULEThe viscosity module supports all viscometers re-gardless of manufacturer or design principle (e.g. single or dual capillary, asymmetric or symmetric bridge). Viscometers directly measure intrinsic vi-scosity without relying on any assumptions.

Validated and proprietary viscometry data proces-sing methods derive true molecular weights and reliable Mark-Houwink constants based on the uni-versal calibration principle. The branching index g’ can be measured across the molar mass distribution.

If one of the light scattering modules and the viscosity module is used at the same time, triple detection is automatically available.

MASS SPECTROMETRY MODULEThe mass spectrometry module supports data import of mass spectrometry data into WinGPC UniChrom. The mass spectrum for every elution volume slice can be reviewed with automatic assi-gnment of the degree of charge, the degree of po-lymerization and the molar mass of the end group. A dedicated calibration curve can be created after automatic band broadening correction to generate true molar masses.

END GROUP ANALYSIS MODULEThe end group analysis software module allows the determination of functionality distribution and absolute molecular weights without the need for calibration standards or light scattering detection. End group data analysis only needs two indepen-dent detector signals for the automatic calculation of the results.

In addition, the calculation of heparin product qua-lity in full compliance with national and internatio-nal pharmacopoeias (e.g. EP, USP, JP, DAB) can be achieved.


Supplies and Services

For Comprehensive Cha-racterization of Natural and Synthetic Macromole-cules

Polymer Standard and Referen-ce Materials

• GPC/SEC Standards and Kits• Certified Reference Materials• MALDI Kits• Viscosity & Light Scattering

Validation Kits• ReadyCal Kits• Deuterated Polymers• Tailor made Polymers and

Copolymers

GPC/SEC Columns• For all Organic Eluents• For all Aqueous Eluents• For High and Low Molecular

Weight Synthetic and Bio-polymers

• From Micro GPC/SEC to Pre-parative Scale

• HighSpeed Columns for fast Analysis

Software• WinGPC UniChrom Macro-

moleculare Chromatography Data System: Light Scattering Modules for LALLS, RALLS, TALLS, MALLS Viscosity Module Mass Spectrometry Module Copolymer Module End Group Analysis Module 2D-Chromatography Module Heparin Module Compliance Pack LAN/Server Solutions

• PoroCheck Software for In-verse GPC/SEC and Pore Size Determination

Systems and Detectors• (Bio)SECcurity² Systems and

Components• Light Scattering Detectors• Viscometers

Analytical Services• Molar Mass Determination• Branching and Structure Ana-

lysis• Method Transfer• Product Deformulation• Consulting• Installation, Training, IQ/OQ,

Maintenance and Service Contracts

GPC/SEC Training and Support• Classroom Style Trainings and

Software Courses• Inhouse Trainings• User Meetings• NetCommunity with Applica-

tions• GPC/SEC Tips&Tricks,

Troubleshooting

Reporting is a Breeze

WinGPC UniChrom Reporting

Reporting is quick and comprehensive. WinGPC ge-nerates detailed and informative reports in many practical formats, e.g.:

• as graphics for word processing• as files for direct data import into LIMS • as electronic reports in PDF, JPG or HTML

format• as printouts of individual samples or overlays

with direct comparison of results

The optional ReportDesigner is available for the individual design of reports. It enables the creati-on of single and multi-page reports based on your own templates and with your company logo and corporate design.

ReportDesigner Analysis Reports

The WinGPC UniChrom ReportDesigner sets the new standard for reporting. By designing your own layouts, possibly modifying one of the attractive PSS example templates, your data can be presen-ted in a targeted manner. The ReportDesigner not only supports the corpo-rate design, but also optimizes work flows by:

automatically setting pass/fail flags based on laboratory-specific quality criteria

allowing for the addition of customized calculations

offering comprehensive comment functions while printing the report

providing statistics calculation functions to simplify the determination of mean values from multiple injections or the documenta-tion of the system utilization

The ReportDesigner supports all modules and functions of WinGPC UniChrom.

www.pss-polymer.com

ContactPSS Polymer Standards Service GmbH

In der Dalheimer Wiese 5D-55120 Mainz, GermanyPhone: +49 (0)6131-96239-0Fax: +49 (0)[email protected]

AmericasPSS-Polymer Standards Service – USA IncAmherst Fields Research Park160 Old Farm Rd, Suite AAmherst, MA 01002, USAPhone: +1 (413) 835 0265Fax: +1 (413) 835 [email protected]

wingpc mcds - comprehensive software for ... - pss-polymer.com€¦ · polymer standards _____ 15...

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