ATS Labs - Excellence in Antimicrobial Testing
 
 
 
Efficacy Testing
New Product Screening
Process Validation
Custom Studies
 

New, Now, and in the Know at ATS Labs

- Medical Device Disinfectants
- We have NDM-1 Positive Organisms
- Treated Articles
- Swine Influenza A (H1N1) Virus
- C. difficile Sporicidal Testing
- Cleanroom Disinfectant Validation
- Gas and Vapor Phase Testing

>> Read more



 


 

Product and Process Validations

 

Validation testing is just no fun. In fact, it is a lot of work. But when the FDA inspector at your facility starts asking those questions, you're thankful you have that validation report in your files. ATS Labs has years of experience helping clients develop robust and comprehensive validations that stand up to FDA scrutiny.

 

ATS Labs understands the importance of validating the practices and processes you use every day and recognizes that no other facility faces the same disinfection challenges that you do. That is why ATS Labs tailors your disinfection validation around your facility's unique processes, surfaces, disinfectant products, and multitude of environmental isolates.

 

Similarly, we know the antimicrobial processes you use to assure the integrity of your product are unique, often involving multiple critical process parameters. That is why we create a custom process validation protocol to assure your process is effective.

Product and Process Validations for FDA Approval – Microbiology Laboratory Services by ATS Labs

Disinfectant Validation and Process Validation testing includes:

 

l  Custom protocols simulating your operations

l  Relevant challenge organisms

l  Realistic testing conditions

l  Antimicrobial neutralization controls

l  Process sensitivity controls

l  Comprehensive QA reviews

l  GLP documentation and reporting

 

We welcome the opportunity to work with you to design validation testing that fits your operations today, and we provide you with GLP documentation to prove it.

 
1285 Corporate Center Drive, Suite 110  -  Eagan  -  Minnesota 55121       651.379.5510       info@ats-labs.com