Syft Tracer Pharm11 for Automated Workflows in Pharmaceutical and CDMO Applications

Syft Tracer Pharm11 is a package solution for high-throughput, automated processes in pharmaceutical and CDMO applications that are 21 CFR Part 11 compliant.Syft Tracer, a CTC autosampler, a High Throughput (HTP) Inlet, and SyftAuditTracer 21 CFR Part 11 compliance software are all included.

Syft Tracer is the latest generation of real-time, direct injection mass spectrometry (MS) that combines trace-level detection sensitivity, unprecedented performance stability, and highly repeatable results.

Syft Tracer Pharm11 is a single configuration for assessing chemically varied compounds using a single technique or switching between methods without the requirement for column changeover or other chromatographic delays.

Using the same instrument setup, users can perform headspace extraction, dissolution in aqueous solvents or non-polar alternatives, and direct sampling from powder or solid headspace back-to-back.

Syft Tracer Pharm11 enables theexamination of more than 200 samples daily, with full user and data traceability. SyftAuditTracer software is entirely compatible with 21 CFR Part 11 and has an easy-to-use data analysis and operation interface.

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Syft Tracer Pharm11 enables users to make critical decisions more quickly.

Features and benefits:

Batch processing of quantitative run results

Trace level multi-analyte detection sensitivity

Highly selective and quantitative

No chromatography or sample prep required

Easy to operate and interpret data

The first and only compliant solution for direct MS

One configuration for multiple, diverse analyses

Autosampler integration tailored to high-throughput SIFT-MS analysis, enabling the analysis of >200 samples/day

Includes HTP Inlet designed for high-throughput applications

Flexibility to append sequences to running batches

SyftAuditTracer is a comprehensive software suite for user and data tracing. This is the first and only real-time mass spectrometry software that complies with 21 CFR Part 11 requirements.

Every stage of the workflow generates an audit trail, including the login procedure, user logs and permissions, data collecting, and data processing.

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SyftAuditTracer is a password-protected system that requires logging in to use the interface. The program can only be used by authorized users. Password expiration, password requirements, and automatic logout after inactivity are all included in the security settings.

SyftAuditTracer audit logs capture which actions were done, by whom, and when, ensuring full traceability from data gathering through reporting completion. Important records (such as data, techniques, audit logs, and reports) are uneditable. Backup capability is included in the program, allowing for regular system backups (e.g.daily, overnight).

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SyftAuditTracer software allows users to configure user roles and permissions. Different privileges (create methods, execute methods, sign off reports, user management, etc.) can be assigned to match the duties of defined roles (admin, analyst, lab manager, etc.). Syft can give default privileges for defined roles as needed.

With an easy-to-use user interface, SyftAuditTracer lets users create, import, and maintain SIFT-MS and autosampler techniques. Users can examine critical pressures and temperatures in hardware, instrument status and faults, and analyte quantitation status.

The steps and outcomes of the daily Performance Tune method are automatically recorded. SyftAuditTracer makes it simple to monitor and attach fresh batches to ongoing sequences.

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SyftAuditTracer has standard data processing facilities such as data visualization, raw signal processing, blank subtraction, quantitation with calibration curves or single point calibration, and the option to export data as CSV files for further processing in other applications.