细菌内毒素检测服务

我们的细菌内毒素检测服务实验室可协助执行关键检测,帮助简化最终产品放行流程。通过与 Charles River 合作,您可以完全放心,经验丰富的专家能帮助您提高内毒素检测计划的合规性和效率,并帮助您实现实验室的控制、一致性和精确性。

如果您能获得一致性更高、更可靠的 BET 结果,同时还能保持 FDA 合规,这会如何?

Endosafe 模块只需回答以下 5 个问题,即可了解哪种快速技术可以帮助您减少分析师培训和重检率,并消除数据输入、收集和解释中的人为错误。回答问题

  • FEATURED SERVICES

    Routine endotoxin detection for non-release applications*

    The bacterial endotoxin testing services performed by Charles River uses customer-requested methods for submitted samples. Our optimized formulations provide increased sensitivity, greater linearity, and superior interference resistance. Endotoxin testing formulations are offered with a comprehensive range of buffers and accessories, providing numerous options for resolving interferences with difficult to test products.

     

    Product validation – one and three lots*

    Before performing product release testing, Charles River offers validation testing for up to three product lots.

     

    Product release testing**

    Charles River can be your partner during this crucial part of ensuring drug product quality and safety. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require lot release tests for each biopharmaceutical batch. 

     

    Stability testing**

    Charles River can test your product for stability after exposure to a variety of environmental factors such as temperature, humidity and light.

     

    Depyrogenation validation

    Charles River offers depyrogenation validation testing from oven validation to stopper washing endotoxin reduction using specifically contaminated articles to verify a 3-log reduction in endotoxin content.

     

    On-site training

    Charles River can create and facilitate training courses on LAL to meet your specifications.

     

    SOP and protocol writing

    Charles River offers SOP and protocol writing assistance to help our customers create a procedure specific to your operation including the activities necessary to complete tasks in accordance with your standards and regulations.

     

    Service Code

    Routine endotoxin determination, non-regulated, any method*

    • Endosafe® cartridge technology
    • Gel-clot - Specific sensitivity requests can be met with ranges that include 0.015 to 0.25 EU/mL for gel-clot.
    • Kinetic chromogenic - Specific sensitivity requests can be met with ranges as low as 0.001 EU/mL for the kinetic chromogenic method.
    • Kinetic turbidimetric
    TS700

     

    Service Code
    Product validation – 3 lots TS203
    Product validation – 1 lot TS201
    Product release testing** - Quality agreement available with this testing TBET1
    Stability testing** - Quality agreement available with this testing TBET1

     

    Additional Services

    Service Code
    Device extraction preparation or special sample preparation such as heat treatment*** TS700E
    Depyrogenation validation (≤ 10 vials) TS203
    Depyrogenation validation (> 10 vials) Inquire when >10 vials
    On-site training TS400
    SOP and protocol writing TS800

     

    Endosafe® LAL proficiency testing program: For schedule information, email [email protected], or contact us at +33 (0) 474 72 28 53.

    *Includes methods development and sample preparation.
    ** 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.

  • AVAILABLE METHODS
  • FRANCE SITE ISO CERTIFICATION

    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.

How can you ensure regulatory compliance?

lab worker checking vials for QAIn order to comply with federal and international regulatory requirements, you must work with a partner that does the same. Our corporate compliance program assures clients, management, and regulators that our work meets your expectations.

Learn More About ISO 17025 Accreditation

Frequently Asked Questions (FAQs) About Endotoxin Testing Services