The pharmaceutical industry requires strict cleaning validation in accordance with GMP (Good Manufacturing Practice) guidelines. ATP testing with the Charm novaLUM II-X provides a fast, objective method for cleaning verification that meets FDA 21 CFR Part 11 and EU GMP Annex 15 requirements.
- Work surface in a controlled area
- Product-contact point after cleaning
- Equipment point from the validation plan
- FDA 21 CFR Part 11 (electronic records)
- EU GMP Annex 15 (cleaning validation)
- ICH Q7 (API manufacturing)
- EMA guidelines for cleaning validation
- WHO GMP guidelines
- ISO 14644 (cleanrooms)
ATP Hygiene Monitoring
novaLINK 6 software meets FDA 21 CFR Part 11 requirements for electronic records: audit trail, electronic signatures and access control.
Use ATP testing as an additional method in cleaning validation studies in accordance with EU GMP Annex 15. Objective data for your validation reports.
Validate cleaning results in 5 seconds instead of waiting hours for microbiological culture results. Increase production capacity.
Set limits based on historical data and automatically receive an alert for deviations. Trend analysis for continuous improvement.