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Analytical and Cleaning Validation

We provide expert support for method validation to ensure reliability and offer data-driven solutions for your cleaning programs

Analytical and Cleaning Validation

We provide expert support for method validation to ensure reliability and offer data-driven solutions for your cleaning programs. Our services includes recovery studies, optimizing your cleaning processes (Cleaning Optimization), and determining acceptable residue limits (MACO Limits Determination), ensuring you have access to industry-best practices.

The integrity of your manufactured products relies on proven cleaning processes and reliable analytical methods. Our specialized service ensures that your cleaning programs are effective, consistent, and fully supported by rigorous data. we validate the analytical techniques used to measure residues and determine scientifically sound limits, providing the necessary assurance for regulatory compliance and product quality across your GxP

Our Offerings

Data Driven Assurance: Validating Cleaning Efficacy and Analytical Methods

Method Validation

Documented proof that analytical procedures are suitable for their intended purpose (eg., accuracy, precision, linearity, limit of detection/ quantitation). Essential for measuring cleaning residues.

Cleaning Program Support

Development and remediation of cleaning validation master plans and protocols. Addressing regulatory gaps and ensuring compliance with FDA, EMA, and other guidelines.

Cleaning Optimization

Utilizing data and scientific principles to refine cleaning procedures, potentially reducing cycle times, chemical usage, and resource consumption while maintaining efficacy.

Recovery Studies

Scientifically determining the efficiency of residue recovery from equipment surfaces. This critical data is used to correct analytical results and calculate accurate final residues levels.

MACO Limits Determination

Expertise in calculating the Maximum Allowable Carryover (MACO) or Health Based Exposure Limits (HBELs) for compounds, providing scientifically justified and defendable cleaning limits.

Audit Readiness

Preparing all validation documentation and data to ensure readiness for regulatory inspections and internal/external audits, establishing a defensible cleaning history.

Why Choose INFItrex?

The Strategic Connector for Critical Talent.

We are the focused bridge for the specialized world of Validation and Data. As a consulting company that places candidates for both clients and vendors, our value isn’t just in filling the position-it’s in securing the precise expertise that drives compliance, quality, and project success. Choose us to access a network of highly specialized professional unavailable through general staffing channels.
  • Specialized Expertise
  • Targeted Placement
  • Quality Compliance
  • Trusted Network