Fast and Efficient High Performance Ion Mobility Spectrometry Proves Convincing PAT for Pharmaceutical Industry | New

ACTON, Mass., July 21, 2021 / PRNewswire-PRWeb / – Excellims Corporation (Excellims), a leading supplier of high performance ion mobility spectrometers (high performance IMS) and compact ion mobility (MS) mass spectrometry, signals its commitment to the pharmaceutical industry with the introduction of compliant online GMP-PAT (Process Analytical Technology) and a growing body of literature demonstrating its value in pharmaceutical applications. Despite its success in security applications, IMS is currently underutilized by the pharmaceutical industry. Excellims has harnessed the inherent advantages of IMS in high-performance instrumentation that brings rapid, GMP-compliant analyzes to the point of need, creating a PAT well suited for applications ranging from reaction monitoring to cleaning validation.

The high performance IMS is particularly suitable for cleaning validation, offering sensitivity and speed. A regulatory requirement (FDA CFR – Code of Federal Regulations Title 21, Sec. 211.67), cleaning validation requires that all manufacturing equipment be free of contamination to ensure safety, identity, strength, quality or the purity of the drug product. Legacy analytical techniques (such as Total Organic Carbon (TOC) and HPLC High Performance Liquid Chromatography) can be time consuming and / or lab-based, keeping production equipment offline for too long. This has sparked the desire for more responsive online or near-the-line technologies.

HPIMS (High Performance Ion Mobility Spectrometry) achieves chemical separation with high resolving power (R> 70) and sensitivity while requiring only 30 seconds for a typical analysis. Combined with electrospray ionization, HPIMS can detect and quantify a wide range of analytes, including isobaric compounds, without the need for complex column selection or non-traditional detectors. Freed from the vacuum hood, HPIMS can be deployed at the point of need and presents a rapid alternative for many applications typically handled by chromatography.

“The pharmacy is a natural home for IMS,” observes Dr Ching wu, founder and CEO of Excellims. “And we are delighted to reaffirm our commitment to this industry. We recognized early on the potential of a high performance IMS to directly address PAT requirements. While many traditional analytical techniques are based on laboratories with long measurement times or excessively heavy instrumentation to measure, HPIMS is inherently well suited for point-of-need implementation. Our HPIMS technology approaches real-time measurement, with the sensitivity required by pharma, right down to the production line.

Excellims offers three HPIMS-based instruments: The first, the GA2200, provides IMS-based chemical detection at the point of need, in minutes, rather than the days associated with laboratory techniques and is the only stand-alone HPIMS designed for the environment. GMP. The second is a rugged and portable integrated HPIMS mass spectrometer (MC3100), which brings two-dimensional chemical detection to address unresolved field detection challenges. Finally, Excillims also allows ion mobility to be added to a lab for six digits, rather than seven using the MA3100, an HPIMS module that can be added to an existing mass spectrometer.

Download more in this white paper on IMS for PAT, or explore the online seminar “Establishment of a rapid, compliant and specific cleaning validation protocol”, a date to be announced soon.

About Excellim:

Founded in 2005, Excellims Corporation is the global innovator of ion mobility solutions for chemical detection. We provide high speed chemical analysis solutions for use in:

  • Pharmaceutical chemistry
  • Food and drug safety
  • Security and Forensic Medicine
  • Medical diagnosis

Excellims has developed High Performance Ion Mobility Spectrometry (HPIMS) to meet the needs of government and industry as they research better ways to detect chemicals with increasing speed and accuracy.

Our analytical tools perform simultaneous separation and detection. Excellims instruments are based on our core technology, High Performance Ion Mobility Spectrometry (HPIMS) and HPIMS-MS. HPIMS is well suited for applications requiring robust analysis that must be performed in harsh environments.

We offer the world’s first ESI-HPIMS (DirectsprayTM) systems for liquids that provide chromatographic-like separation with simultaneous detection. Quick-to-change source options add versatility for liquid, solid or gas samples.

We manufacture a full line of chemical analysis and detection products for research, industry and government.

http://www.excellims.com

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For media inquiries in the United States

Laura Browne

[email protected]

+1 978 893 9618

For media inquiries in Europe

Contact:

Claire England

[email protected]

+44 (0) 7808 020554

Media contact

Lexi chapin, Excellims Corporation, +1 7819573130 Ext: 6, [email protected]

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SOURCE Excellims Corporation


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