GE Analytical Instruments is a leader in helping global organizations use TOC analysis for cleaning validation.
Cleaning Validation and Verification
More and more life sciences and pharmaceutical companies are using TOC analysis to replace older, more traditional methods for Cleaning Validation (CV) applications. TOC analysis is a simpler and more reliable replacement for the traditional complex HPLC-based equipment cleaning and cleaning validation applications. Other advantages include:
- Application versatility
- Accuracy in measuring contaminant residues
- Faster analysis time
- Cost-effectiveness
- Real-time analysis feedback of rinse/cleaning status
The FDA views TOC as an acceptable cleaning validation method, based on a number of studies demonstrating the adequacy of total organic carbon (TOC) in measuring contaminant residues. (Click here to review the FDA's position on TOC and cleaning validation.) TOC analysis is suitable for quality assurance testing, equipment release, USP release, swab sampling, rinse sampling, clean in place (CIP) applications, and on-line process control to satisfy the FDA’s Process Analytical Technology (PAT) initiative.
GE Analytical Instruments is the leader in cleaning validation using TOC, and offers a wide range of instruments, documentation, and training to help you develop and manage a cleaning validation program. We are also at the forefront of cleaning validation technology with our Sievers 500 RL On-Line TOC Analyzer. Learn more about our cleaning validation solutions:
- Laboratory (swab sampling) cleaning validation
- On-Line cleaning validation
- At-line cleaning validation
Customers who use swab sampling often have inconsistent swab sample test recovery rates. Find out why in Pharmaceutical Technology's new Q&A column.