Author: Megd

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Kansas Analytical Services LLC announced today the appointment of Lillian Lynn as Quality Assurance Manager.  John Heinrich, the managing partner of KAS said, “Lillian’s appointment is an important part of our continuing efforts to expand our business and serve our clients more effectively.  Lillian has an outstanding background in quality assurance and regulatory affairs and will assume full-time responsibility for our good manufacturing practices program  and data integrity practices and other quality matters.”

We are continuing to improve our capabilities to serve our clients in the pharmaceutical community.  We have several recent developments we are pleased to report on.

New Experimental Capability

KAS recently took delivery of a Bruker AvanceNEO three channel spectrometer.  The NEO is Bruker’s most recent product offering and provides a wide range of new features including multi – channel transmit and receive capability, a range of options for system operation and data analysis, and compatibility with Topspin 4, Bruker’s newest NMR software.  For KAS clients, this means access to state-of-the-art experimental capability and improved reliability and redundancy as we continue to operate our existing Avance spectrometer.

Implementation of Good Manufacturing Practices

KAS has completed the implementation of Good Manufacturing Practices (GMP) on the NEO system.  Bruker has recently installed a new version of Topspin 4 which is designed to support compliance with 21 CFR Part 11, This software provides complete capability for the implementation of data integrity (DI) practices including audit trails, data set locking, electronic signatures, and other features.  For KAS clients, this means the opportunity to perform analyses requiring GMP compliance including lot release and post-marketing surveillance.

Protocols for Analysis of Highly Potent Compounds

KAS has developed and validated a protocol for safely analyzing highly potent compounds including Band 4 and Band 5 materials.  The protocol is based on a triply redundant sample containment system originally developed for the analysis of radioactive materials and includes a ventilation system that captures any material that might escape the sample containment system.  For KAS clients, this means the capability to use the power of solid state NMR to characterize compounds that are impossible to analyze in-house.

We look forward to better serving your needs for solid state NMR analysis.

John P. Heinrich, Ph.D.

Managing Partner

KAS has had a number of requests from clients to analyze band 5 compounds, which are highly potent pharmaceutical compounds with an occupational exposure limit of <1ug/m³.  KAS has successfully completed an environmental health and safety (EHS) audit by a major client and is now able to safely analyze these compounds.  The client is a member of the Pharmaceutical Supply Chain Initiative (www.pscinitiative.org) and will make the results of the audit available to all PSCI members in redacted form so that they are not required to perform individual audits.

KAS has recently completed its implementation of GMP procedures for solid state NMR.  KAS is now able to offer its clients fully GMP compliant analysis.  Please contact the managing partner, John Heinrich (johnh@kansas-analytical.com) for further information.

In late 2016 KAS relocated to a new facility in Loveland, CO.  KAS shares this facility with PhoenixNMR, a supplier of state-of-the-art solid state NMR probes.  KAS has its own dedicated, secure laboratory space within the Phoenix facility.  The colocation provides KAS with access to NMR instrument expertise and repair services and helps ensure uninterrupted analytical services for our clients.