• Manufacturing Systems

 
 
 

Cleaning Validation

"One must recognize that for cleaning validation, as with validation of other processes, there may be more than one way to validate a process. In the end, the test of any validation process is whether scientific data shows that the system consistently does as expected and produces a result that consistently meets predetermined specifications." – FDA Guide to Inspections: VALIDATION OF CLEANING PROCESSES.

USDM provides companies in the Life Science Industry with industry proven validation consultants that are experienced in all aspects of Cleaning Validation. USDM has qualified and validated numerous Clean in Place (CIP) and Steam in Place (SIP) systems and adhere to Regulatory, USP, and ISPE guidelines for performing cleaning validation.

USDM cleaning validation services include:

  • Equipment Design
  • Evaluating the Complexity of the Equipment
  • Standard Operating Procedures (SOP)
  • Determining the specificity and sensitivity of the analytical method used.
  • Sampling
  • Direct Surface Sampling
  • Rinse Samples
  • Monitoring - Indirect testing
  • Establishing Residual Limits
  • Validation
 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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