Achieve Compliance with Reliable Cleaning Validation
Minimize manufacturing downtime with our meticulous cleaning validation. We analyze surfaces for potential contaminants to ensure your processes maintain compliance. Whether your program is developing new processes, expanding product lines, or remediating previous methods, our expert team offers support at any phase.
From API or detergent residue to each equipment component, we thoroughly evaluate every aspect of your processes to provide reliable cleaning validation services and results. Our team also provides expert guidance to identify overlooked problem areas or address issues that concern regulators. Cross contamination causes costly errors, which is why our comprehensive services validate your processes from start to finish.
Easier Cleaning Validation Protocol
We support various regulatory standards, equipment, and materials. For example, TOC cleaning validation, GMP cleaning validation, and ICH cleaning validation are all common requests for our laboratory.
Coupon Catalog
Our coupon catalog provides representatives for the manufacturing materials necessary to validate potential cross contamination. This selection includes aluminum, steel, acrylic, and various plastics, such as HDPE, LEXAN, Delrin, and polycarbonate.
Custom Kits
We provide custom test kits to simplify sampling into a ready-made approach. Our team prepares the solutions and other necessary materials so all you need to do is collect samples and send the cleaning validation swabs back for testing.
Secure Data Accessibility
Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®. PacePort® is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.
The copies are offered in high-resolution and in color, giving your team easy and clear viewing for review. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort® is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.
Integrated Laboratory Services
When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.
Additional Resources
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.