Cleaning Validation
Tom Woody
- Developed and implemented risk-based cleaning strategy to manufacture dietary supplements on same GMP equipment as APIs.
- Developed and implemented successful solvent based cleaning method and carryover limits for use with adhesive-based manufacturing process.
- Successfully developed and implemented reduced tank cleaning method eliminating detergent use and manual interventions.
Contact Tom at 888.366.7660.
Cleaning Validation
Cleaning Validation tailored, executed and delivered. From developing defensible carryover limits to implementing cost-effective cleaning validation strategies, IPS has the Knowledge, Skill and Passion to meet each client’s unique needs.
Compliance
- Audits and risk analyses of cleaning programs vs. industry standards and regulatory requirements
- Assistance with regulatory and customer audits and observations
- Troubleshooting and investigation into cleaning related issues
- Identification and control of critical cleaning process parameters
Development
- Assistance with analytical method development
- Assistance with developing equipment cleaning methods for specific products/actives
- Development and execution of swab recovery program for actives and cleaning agents
- Development of periodic review program for cleaning validation processes
Verification/Validation Activities
- Calculation of justifiable carryover acceptance criteria for specific actives and cleaning agents
- Research and drafting of cleaning verification/validation protocols and reports
- Providing on-site resources for cleaning verification/validation protocol execution including swab/rinse sampling of equipment
- IQ, OQ, DPQ and PQ execution of cleaning equipment including CIP systems
Specialized Services
- Clearing equipment used with highly potent actives using defensible rationale
- Customized strategies to save on-going costs including improved cleaning methods, product/equipment grouping, campaigning, dirty/clean hold times and swab recovery work
- Presenting and implementing unique cleaning approach aligning with FDA’s new process validation guidelines
- Focused cleaning validation presentations and training activities to meet company objectives
- Providing periodic maintenance of manufacturing equipment including derouging and passivation of stainless steel surfaces