Validation Services

Professional, Efficient, and Reliable Filter Validation Solutions

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Aliothr^® Validation Center

World-leading Infrastructure

Located in Lingang, Shanghai, our 800 m² validation center is equipped with LCMS-MS, HSGCMS, DIGCMS, SEM, online steam sterilization systems, FTIR, and subvisible particle analyzers.

Comprehensive Validation Services

Provide process-specific validation services for filters and single-use systems, including extractables & leachables studies, chemical compatibility, bacterial retention, and adsorption testing — helping customers validate filtration process effectiveness and reliability while meeting regulatory compliance.

Trusted Quality Assurance

Operates under ISO 9001, accredited by CNAS, and independently audited by LRQA — ensuring data integrity, accuracy, and traceability.

Experienced Professional Team

Core personnel come from leading global filtration companies' validation laboratories, with years of hands-on project experience and proven professional capabilities recognized across the industry.

Alipharma^® Validation Services

Compatibility Report

Reaction assessment

Adsorption Report

Drug adsorption

Extractables/Leachables Report

Released substances

Safety Assessment Report

Toxicity evaluation

Bacterial Challenge Report

Retention efficiency

Reuse Bacterial Challenge Report

Reused filters

Reuse Compatibility Report

Reused filters

Validation Process

Starting from customer needs, we deliver streamlined, data-driven validation services — from validation recommendations, protocols to final reports farmatted for regulatory review.

RequirementsProcess ValidationRecommendationProtocolReport

Validation Recommendation

A regulatory-compliant assessment of the customer's process will be conducted to establish a validation plan, functioning as the Master Validation Plan for this process.

Validation Protocol

Formulate a regulatory-compliant validation protocol that outlines the rationale, methods, critical parameters, and acceptance criteria, alongside a predefined action plan for potential deviations.

Validation Report

Provide raw test data and calculation methods, derive validation conclusions based on test results, and offer regulatory compliance consulting services.

How to Select Validation Services?

Select the most suitable combination of validation items based on your filtration application scenario and regulatory requirements.

Recommended Validation for Single-use Systems

To meet FDA, EMA, and NMPA compliance, we recommend:

Bacterial Retention Test (BRT) — Confirms microbial retention
Chemical Compatibility — Verifies filter-fluid resistance
Adsorption Study — Evaluates active ingredient loss
Extractables & Leachables (E&L) — Assesses material safety

Customized Validation Strategies

Every process is unique. We design customized protocols based on your specific parameters (temperature, pressure, flow rate, contact time, solution composition) to ensure compliance and cost-efficiency.

Resource Downloads

Access technical resources and guideline documents.

Online Message

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