Single-Use System Validation | Sterilizing Grade Validation | Virus Clearance | Risk Assessment

Validation Services

Regulatory Compliance Adherence

LePure Validation Service Center, based in Shanghai, China, specialized validation services catering to single-use systems, sterilizing-grade filters, particle analysis, traceability assessments, water-for-injection (WFI) quality control, release testing, and more.

Our commitment to excellence is underpinned by a robust quality assurance program aligned with ISO9001 and ISO17025 standards, ensuring that our clients receive top-tier validation and testing solutions.

At the heart of our mission, LePure Validation Service Center embraces the values of professionalism, excellence, cooperation, and mutually beneficial partnerships. Our dedicated team of experts is poised to deliver testing services that are characterized by their unwavering commitment to quality, rapid response times, and comprehensive support, all in strict adherence to pertinent regulatory requirements. We are dedicated to becoming the trusted and dependable partner for each and every one of our valued customers.

Contact Our Validation Service Team

Single-Use System Validation

In biopharmaceutical manufacturing, single-use systems require validation, including chemical compatibility, adsorption, and Extractable & Leachables testing. Extractable & Leachables testing is crucial. Testing components is based on the risk of unsuitability. Once data is available, safety evaluation, considering production batch size and dosing regimen, ensures patient safety regarding extracted compounds.

  • Efficient Localization: Streamlining design, production, radiation, and validation for rapid delivery.
  • Advanced Analysis: Utilizing cutting-edge analytical tools for thorough extractables/leachables characterization.
  • Expert Support: A dedicated technical team offering regulatory guidance, technical assistance, and validation expertise.
  • Robust Quality Assurance: Ensuring trustworthy, transparent, and traceable data.

Sterilizing Grade Validation

Ensuring product safety and sterility is paramount. Filtration processes, especially for sterilizing-grade filters, must meet regulatory standards. This entails process-specific validation considering factors like time, temperature, and product. Validation includes bacterial challenge, adsorption, chemical compatibility, and extractables & leachables testing, followed by safety evaluation.gna aliquam erat volutpat.

  • Holistic Process Assessment: Assessing multiple factors in sterilizing filtration for rational process conditions, ensuring drug effectiveness and safety.
  • Advanced Analysis: Using state-of-the-art instruments for thorough extractables and leachables characterization.
  • Expert Support: A proficient technical team offering regulatory guidance, technical assistance, and validation experiments.
  • Sturdy Quality Assurance: Maintaining data authenticity, integrity, and traceability.

Virus Clearance

Drug regulatory agencies in various countries require that the purification and production process of biological products extracted from human or animal tissues or body fluids, animal-derived monoclonal antibodies, and recombinant products expressed by eukaryotic cells must conduct virus clearance/inactivation validation in the application materials before clinical trial and production stage.

  • Cost Control: Domestically produced virus clearance product as a cost-effective alternative to reduce production costs.
  • Advanced Analysis: Utilizing advanced and comprehensive instruments, along with a P2 laboratory, to meet virus clearance validation requirements.
  • Expert Support: A dedicated technical team offering regulatory guidance, technical assistance, and validation expertise.
  • Robust Quality Assurance: Ensuring trustworthy, transparent, and traceable data.

*Note: Virus Clearance Validation Service is only available in Mainland China.

Risk Assessment

Assessing and controlling risks associated with single-use systems (SUS) is crucial for pharmaceutical companies and regulatory agencies. These assessments ensure patient safety, drug efficacy, and quality throughout R&D and commercial manufacturing. Various changes can occur during different drug lifecycles and manufacturing stages, impacting drug quality, safety, and efficacy. Scientific and rational risk evaluations for these changes are essential.

  • Comprehensive Approach: Examining the entire process for one-time use system risk assessment.
  • Multi-dimensional Analysis: Ensuring drug quality, safety, and efficacy through thorough consideration of various factors.
  • Scientific Risk Assessment: Utilizing evidence-based, risk-oriented models for assessments.
  • Expert Team: Providing regulatory insights, technical support, and document drafting by professionals.
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