Ensure Your Facility Meets the Highest Standards with GMP & CFR 21-Compliant Cleaning Validation Solutions. Specialized Services for Pharmaceutical, Biotech, Hospital and Outsourcing Facilities to Guarantee Safety, Compliance, and Efficiency.
Protect Your Products, Patients, and Business
In the pharmaceutical and biotech industries, maintaining cleanliness isn’t just a best practice — it’s a regulatory requirement. Our comprehensive cleaning validation services are designed to meet the strict guidelines of CGMP (current Good Manufacturing Practices) and CFR 21 regulations, ensuring your facility is safe, compliant, and audit ready. Partner with us to safeguard your operations, protect your products, and enhance patient safety.
What is Cleaning Validation?
It demonstrates that a pharmacy, hospital, or outsourcing facility’s cleaning procedure is effective and consistent in cleaning equipment and compounding surface areas. It provides documented evidence that the cleaning process can be performed reliably and repeatedly to remove residues of API, excipients, degradation products and cleaning agents’ or decrease them to acceptable levels that satisfy a predetermined and acceptable level of cleanliness.
Why Do I need it?
Protocol development, execution, and documentation tailored to your processes and equipment.
Fully aligned with cGMP and CFR 21 Part 211 requirements, ensuring readiness for FDA and other regulatory audits.
Minimized risks of cross-contamination to protect product integrity and patient safety.
Streamlined cleaning processes save time and resources without compromising quality.
Let Our Experience Work For You!
Why Choose Us ?
Industry professionals with over a decade of experience in pharmaceutical compliance and operations. Cleaning validation at Eagle is performed utilizing both specific and nonspecific analytical techniques to validate the cleaning process, including analyte-specific measurement, total organic carbon (TOC) measurement, and bioburden testing.
Who Do We Serve?
- Pharmaceutical Manufacturers
- Biotechnology Firms
- 503B Outsourcing Facilities
- Compounding Pharmacies
- Hospitals
Our Cleaning Validation Services Include:
Residue Analysis:
Establishing scientifically justified acceptable residue limits and implementing appropriate detection methods.
Risk Assessments:
Identifying critical cleaning parameters and developing risk-based strategies.
Validation Protocols:
Comprehensive Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services.
Analytical Testing:
Employing validated methods HPLC, TOC, and swab/rinse sampling to verify cleaning effectiveness.
Revalidation Services:
Regular updates to ensure compliance with evolving regulatory standards and changes in manufacturing processes.
Explanation of Studies
Cleaning validation is essential in assuring that product contact equipment is essentially free of residual active drug , cleaning agents, and microbial contamination. Cleaning validation at Eagle is performed utilizing both specific and nonspecific analytical techniques to validate the cleaning process, including analyte-specific measurement, total organic carbon (TOC) measurement, and bioburden testing.
Analyte-specific Method Development and Validation
An analytical method will be developed and validated for the specified analyte(s), typically the active pharmaceutical ingredient (API). Validation of the method will include specificity, linearity, limit of detection (LOD) and limit of quantitation (LOQ) determination, and accuracy/recovery studies.
USP <643> Total Organic Carbon (TOC) Measurement
TOC measurement is a nonspecific technique that evaluates the overall effectiveness of the cleaning process and is ideal for detecting all carbon-containing compounds including the API(s), excipients, and cleaning agents.
Bioburden Testing
Bioburden testing, provides a quantitative measurement of the microbial surface to evaluate the effectiveness of the cleaning process in reducing microbial contamination to a specified limit.
To learn more about Cleaning Validation, contact a member of our Client Care Team today.
Get Started Today
Got Validation Needs?
Call the Eagle Client Care Team at (800) 745-8916 to discuss your operation’s specific needs.