About This Service
AnalytiLab provides cleaning validation services to demonstrate that pharmaceutical manufacturing equipment is adequately cleaned between production batches. Our services include development and validation of analytical methods for swab and rinse samples, determination of acceptance limits, and preparation of cleaning validation protocols and reports per FDA cGMP and EMA guidelines.
Key Information
Accredited by
What's Included
Instruments Used
HPLC (UV/PDA)
API residue quantification in swab/rinse
TOC Analyzer
Total organic carbon in rinse water
UV-Vis Spectrophotometer
Rapid screening of API residues
ICP-OES
Detergent residue (phosphate) analysis
Regulatory Standards
How We Work
Limit Calculation
MACO and acceptance limits calculated based on therapeutic dose and batch size.
Method Development
Sensitive HPLC/TOC method developed and validated for swab/rinse matrices.
Recovery Studies
Swab recovery studies performed on representative equipment surfaces.
Validation Report
Full cleaning validation report with protocol, data, and compliance statement.
Ready to Start Your Cleaning Method Validation?
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Related Services
Pharmaceutical Testing
Complete testing of APIs, formulations, excipients & finished products as per USP, EP, BP, IP, and ICH guidelines.
Analytical Method Development & Validation
Stability-indicating, residual solvent, dissolution, and cleaning validation methods per ICH/FDA/USP guidelines.
Stability Studies
ICH-compliant long-term, accelerated, and stressed stability studies with 24/7 monitored climatic chambers.