Bacterial Endotoxin Testing Services

Our bacterial endotoxin testing services laboratory can support you with performing your critical tests to help streamline the process to final product release. By partnering with Charles River, you can be confident that our experienced specialists can help improve the compliance and efficiency of your endotoxin testing program and help you to achieve control, consistency and precision in your laboratory.

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  • FEATURED SERVICES
    • Product validation programs – one and three lots
    • Endosafe® LAL proficiency testing program: For schedule information, email [email protected], or contact us at +33 (0) 474 72 28 53.
    • Regulatory compliance consultation
    • Methods development
    • On-site training
    • Reader/software qualification
    • Product release/stability testing
    • Sample preparation
    • Routine endotoxin detection for non-release applications
    • SOP and protocol writing

     

    Available Methods

    Product Code
    Method development TS100
    Routine endotoxin determination, non-regulated, any method
    PTS™
    Gel-clot
    Kinetic chromogenic
    Kinetic turbidimetric
    TS700

    Gel-Clot, Kinetic Chromogenic, and Kinetic Turbidimetric Techniques

    Product Code
    Product validation – 3 lots TS203
    Product validation – 1 lot TS201
    Product release or stability test* TBET1

    * Product validation must be completed prior to finished product release or stability testing.

    PTS™ Technique

    Product Code
    Product validation – 3 lots TS203
    Product validation – 1 lot TS201
    Product release or stability test* TBET1

    * Product validation must be completed prior to finished product release or stability testing.

    Additional Services

    Product Code
    Stability testing* TBET1
    Device extraction preparation or special sample preparation such as heat treatment** TS700E
    Oven validation/testing of challenge vials (≤ 10 vials) TS203
    Oven validation/testing of challenge vials (> 10 vials) TS203
    Special Certificate of Analysis (COA) testing TCOA1
    On-site training† TS400
    SOP and protocol writing TS800

    * Product validation must be completed prior to finished product release or stability testing.
    ** If Charles River prepares the extraction or treats the sample, there is an additional price per sample.
    † Travel expenses additional.

  • FRANCE SITE ISO CERTIFICATIONS

    ISO 9001:2015: Quality Management Systems

    ISO 9001:2015 concerns all of the activities carried out at the Charles River Endotoxin Microbial Detection site in Ecully (Lyon), France, as defined by the sale of material, equipment and reagents, provision of services, and training related to carrying out tests in laboratories in the field of endotoxin detection and microbial identification.

    About ISO 9001:2015
    ISO 9001:2015 sets out the criteria for quality management systems. It can be used by any organization, large or small, regardless of the field of activity. In fact, ISO 9001:2015 is implemented by over one million companies and organizations in over 170 countries. The standards outlined in ISO 9001:2015 are based on a number of quality management principles, including a strong customer focus, the motivation and implication of top management, a process-oriented approach and continual improvement. Using these standards helps ensure that customers get consistent, quality products and services.

    ISO 17025:2005 General Requirements Regarding Laboratory Proficiency Testing

    This ISO 17025:2005 documentation only relates to one part of the Charles River Endotoxin Microbial Detection site in Ecully (Lyon), France, namely the carrying out of bacterial endotoxin tests. Our laboratory has been ISO 17025:2005 accredited since April of 2007.

    About ISO 17025 and Accreditation
    The aim of an accreditation procedure is to establish trust in the service provisions fulfilled. Accreditation is required to represent the level of conformity assessment activities in terms of technical competence. ISO 17025 accreditation certifies the technical competence of testing laboratories to perform specific tasks. Accreditation guarantees that the results are obtained according to valid methods and procedures that comply with precise standards. Assays are carried out according to European Pharmacopoeia Chapter 2.6.14, Bacterial Endotoxins. Note: since January 2000, this text has been harmonized with the Japanese and American Pharmacopoeias (JP 4.01 and USP Chap. <85>, respectively).