At-line cleaning validation reduces analytical testing time and allows you to gain near-instant results
Cleaning validation (CV) is an integral component to current Good Manufacturing Practice (cGMP) to ensure the safety and purity of products. By moving cleaning validation out of the laboratory to an at-line location, your CV program can become more automated and efficient; these improvements align with process analytical technology (PAT) initiatives and Pharma 4.0 guidelines.
eBook: Total Organic Carbon (TOC) for Cleaning Validation Programs
Integrate cleaning validation onto the manufacturing floor to achieve efficiency gains by:
- Significantly reducing turnaround time for results, enabling faster batch release, and improved production efficiency
- Decreasing opportunity for human error and sample degradation/contamination during transport to the lab
- Reducing the need for sample storage and handling
- Reducing laboratory workload and waste
Want to know more? Evaluate at-line cleaning validation systems with the educational resources below. Learn key considerations, industry best practices, and expert insights to help you make an informed decision in whether moving to at-line cleaning validation is right for your facility.
Wondering if you should move your cleaning validation program out of the QC lab and onto the manufacturing floor? We can help you decide.
At-Line Cleaning Validation Resources
Cleaning Validation Overview
eBook: Total Organic Carbon (TOC) for Cleaning Validation Programs
Discover how TOC testing ensures compliant equipment cleanliness in pharmaceutical manufacturing and gain comprehensive insights into its implementation - download our essential e-book to master TOC for cleaning validation.
Top 5 Secrets to a Successful Cleaning Validation Program
This fact sheet helps teams to identify areas for improving their cleaning validation programs.
Article: Comparing Lab, At-Line, and Online TOC for Compendial Water Testing and Cleaning Validation
This article provides detail about each testing approach and how it can optimize operational efficiency needs of water purity and equipment cleanliness monitoring while meeting regulatory compliance requirements. Compare efficiency, benefits, and use cases for deployment of laboratory, at-line, and online TOC and conductivity testing.
Validating the TOC Method for Cleaning Validation Applications in the Pharmaceutical Industry
When validation TOC methods, laboratory studies must establish that performance characteristics meet certain requirements for the intended analytical applications. Read our application note detailing examples using Sievers TOC Analyzers of various parameters, including linearity, percent recovery, and precision, as it relates to TOC method validation for cleaning validation.
Article: Annex 1 and Cleaning Validation - How At-line and Online Analytical Methods Can Enhance Your Contamination Control Strategy
Written for and published with American Pharmaceutical Review: This article discusses revised Annex 1 to detail enhanced contamination control strategies in cleaning validation, where implementing at-line and online analytical methods can improve process understanding, reduce equipment downtime, and strengthen quality control - discover how to optimize your cleaning validation program with these advanced monitoring approaches.
Evaluation, Verification, and Justification for At-line Cleaning Validation
How Does Cleaning Validation Testing in the Lab Compare to Online or At-line Cleaning Validation?
Learn how TOC and conductivity monitoring enhance cleaning validation in cGMP manufacturing. Compare laboratory, at-line, and online analysis methods, benefits and other considerations when evaluating cleaning validation processes.
Process Analytical Technology (PAT) Application: At-Line Total Organic Carbon (TOC) for Cleaning Validation and Product Changeover
The Sievers M9 can be used on the production floor, where sampling occurs at-line following a CIP of the column using the Integrated On-Line Sampler (iOS). Typically, product changeover or the periodic monitoring of samples can be completed within minutes or hours using the Sievers M9 Portable, providing efficiency gains for single or multi-product facilities.
Justifying Total Organic Carbon (TOC) Limits Based on Process Capability - Determining TOC Process Capability for Swab And Rinse Sample
Explore our guide to implementing effective one-sided acceptance criteria for your cleaning validation program. Learn how to leverage TOC data and process capability analysis to establish practical, and verifiable cleaning limits.
Total Organic Carbon (TOC) Monitoring Efficiency Quiz
Take a 10 question quiz to help QA/QC teams identify areas for UPW monitoring improvements with TOC.
Sievers Solutions
Sievers Validation Support Package for Cleaning Validation (VSPCV)
The Validation Support Package for Cleaning Validation (VSPCV) is a documentation set that guides the use of Total Organic Carbon (TOC) in cleaning validation. It includes guidance, examples, worksheets, templates, and protocols to streamline cleaning validation processes using Sievers TOC Analyzers.
Sievers Total Traceability - Certified Reference Materials & Vials for TOC Analysis
This application note discusses how you can ensure ongoing assurance of quality data for traceability, effectiveness (compliance) and efficiency (cost) with your TOC instruments.
Sievers M9 TOC Analyzers
Sievers M9 Total Organic Carbon (TOC) Analyzers provide stable and precise TOC measurement for ultrapure and pharmaceutical water monitoring. Choose laboratory, portable, or online instruments that provide simultaneous TOC and optional Stage 1 conductivity testing.
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Cleaning Validation Overview
Cleaning Validation Overview
eBook: Total Organic Carbon (TOC) for Cleaning Validation Programs
Discover how TOC testing ensures compliant equipment cleanliness in pharmaceutical manufacturing and gain comprehensive insights into its implementation - download our essential e-book to master TOC for cleaning validation.
Top 5 Secrets to a Successful Cleaning Validation Program
This fact sheet helps teams to identify areas for improving their cleaning validation programs.
Article: Comparing Lab, At-Line, and Online TOC for Compendial Water Testing and Cleaning Validation
This article provides detail about each testing approach and how it can optimize operational efficiency needs of water purity and equipment cleanliness monitoring while meeting regulatory compliance requirements. Compare efficiency, benefits, and use cases for deployment of laboratory, at-line, and online TOC and conductivity testing.
Validating the TOC Method for Cleaning Validation Applications in the Pharmaceutical Industry
When validation TOC methods, laboratory studies must establish that performance characteristics meet certain requirements for the intended analytical applications. Read our application note detailing examples using Sievers TOC Analyzers of various parameters, including linearity, percent recovery, and precision, as it relates to TOC method validation for cleaning validation.
Article: Annex 1 and Cleaning Validation - How At-line and Online Analytical Methods Can Enhance Your Contamination Control Strategy
Written for and published with American Pharmaceutical Review: This article discusses revised Annex 1 to detail enhanced contamination control strategies in cleaning validation, where implementing at-line and online analytical methods can improve process understanding, reduce equipment downtime, and strengthen quality control - discover how to optimize your cleaning validation program with these advanced monitoring approaches.
-
Evaluation, Verification, and Justification for At-line Cleaning Validation
Evaluation, Verification, and Justification for At-line Cleaning Validation
How Does Cleaning Validation Testing in the Lab Compare to Online or At-line Cleaning Validation?
Learn how TOC and conductivity monitoring enhance cleaning validation in cGMP manufacturing. Compare laboratory, at-line, and online analysis methods, benefits and other considerations when evaluating cleaning validation processes.
Process Analytical Technology (PAT) Application: At-Line Total Organic Carbon (TOC) for Cleaning Validation and Product Changeover
The Sievers M9 can be used on the production floor, where sampling occurs at-line following a CIP of the column using the Integrated On-Line Sampler (iOS). Typically, product changeover or the periodic monitoring of samples can be completed within minutes or hours using the Sievers M9 Portable, providing efficiency gains for single or multi-product facilities.
Justifying Total Organic Carbon (TOC) Limits Based on Process Capability - Determining TOC Process Capability for Swab And Rinse Sample
Explore our guide to implementing effective one-sided acceptance criteria for your cleaning validation program. Learn how to leverage TOC data and process capability analysis to establish practical, and verifiable cleaning limits.
Total Organic Carbon (TOC) Monitoring Efficiency Quiz
Take a 10 question quiz to help QA/QC teams identify areas for UPW monitoring improvements with TOC.
-
Sievers Solutions
Sievers Solutions
Sievers Validation Support Package for Cleaning Validation (VSPCV)
The Validation Support Package for Cleaning Validation (VSPCV) is a documentation set that guides the use of Total Organic Carbon (TOC) in cleaning validation. It includes guidance, examples, worksheets, templates, and protocols to streamline cleaning validation processes using Sievers TOC Analyzers.
Sievers Total Traceability - Certified Reference Materials & Vials for TOC Analysis
This application note discusses how you can ensure ongoing assurance of quality data for traceability, effectiveness (compliance) and efficiency (cost) with your TOC instruments.
Sievers M9 TOC Analyzers
Sievers M9 Total Organic Carbon (TOC) Analyzers provide stable and precise TOC measurement for ultrapure and pharmaceutical water monitoring. Choose laboratory, portable, or online instruments that provide simultaneous TOC and optional Stage 1 conductivity testing.