Cleaning Validation Capabilities

Kymanox® utilizes a controlled, quality-driven process that manages risk and ultimately ensures a safe and effective product for the patient.

Robust Cleaning Programs 

Kymanox can help your organization develop robust cleaning programs that consistently and reliably result in equipment and devices that are clean to requisite levels.
Explore More

Validation Experts 

Our cleaning experts develop cleaning validation master plans and validation using reasonable worst-case conditions. We can also perform assessments of gaps and risks in your current cleaning processes.
Explore More

Analysis, Execution, and Training

Kymanox can help identify required analytical methods and sampling. We are also unmatched when it comes to execution of cleaning process qualifications, as well as delivery of comprehensive training.
Explore More

Life Cycle Management

When it comes to the implementation of life cycle management and process surveillance, Kymanox has a track record of developing the highest quality solutions in the industry.
Explore More

Meet our Cleaning Validation Solutions Experts

Michelle Frakes, PhD

Markets That Benefit from Our Cleaning Validation Solutions

Combination Products

Our experts understand the interaction between devices and drug products and are ready to support your next project


In the dynamic realm of biotechnology and cell and gene therapy we continue to offer innovation solutions and guidance


Drug development is constantly evolving with new regulations and technology, we stay up to date to maintain your compliance

Medical Devices

Building on over three decades of experience in the medical device industry, Kymanox has been at the forefront of innovation

The Kymanox Difference

At Kymanox we are more than consultants. We are partners with our clients and create custom solutions that meet each client’s unique needs.
about image

Proven Broad Expertise

Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.
Read More
about image

Flexibility & Agility

At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
Read More
about image

Dynamic Project Management

A personalized approach to project management that combines your needs with our proven tools and expertise to create a custom solution for your project.
Read More

Frequently Asked Cleaning Validation Questions (FAQs)

Where do you start when implementing a cleaning validation process?
A risk assessment is necessary to assess the cleaning validation strategy and the level of validation required for each cleaning procedure.  Some criteria that may be considered, if applicable, in the risk assessment are as follows.  This list is not considered an all-inclusive list and additional criteria may be applicable for a specific cleaning procedure. 
  • Solubility of process soils 
  • Dosage levels, toxicity, potency of process soils 
  • Equipment design, construction, surface material of construction 
  • Dedicated vs. multi product equipment 
  • Non-sterile vs. sterile processing 
  • Location of equipment step within overall process 
  • Manufacturing campaigns 
  • Batch size and possible changeovers 
  • Processing time 
  • Cleaning procedure (manual, semi-automated, fully automated) 
  • Cleaning intervals 
  • Equipment holding times (dirty and clean) 
  • Acceptance criteria 
  • Number of products covered by the cleaning procedure 
  • Cleaning agent residuals 
  • Subsequent equipment sterilization 
  • Equipment soiling (artificial soiling vs. actual processing) 
  • Equipment loading 
  • First vs. re-validation 
Are there any pre-requisites to consider before beginning a cleaning validation process?
Prior to initiating formal cleaning validation, several activities must be completed.  Equipment qualification activities for the associated equipment must have been successfully completed.  For equipment that is cleaned with a spray device, coverage studies must be completed with acceptable results.  For equipment cleaned with automated cycles, the cleaning cycle automation must be qualified.  The cleaning procedure for the equipment must be documented and approved.  Note: Cleaning procedures may need to be revised at the completion of cleaning validation activities to incorporate any recommendations from the validation effort.  Also, analytical assays used during the validation study and the instruments used to perform these assays must be validated.
What types of changes require re-validation of a cleaning process?
Changes resulting from new regulatory guidance, process improvements or new products can affect the validated status of cleaning cycles.  These changes can include changes to validated cycle parameters, changes to procedures or hold times, software upgrades, new loads or load configurations, changes to equipment or piping, changes to products, or changes to cleaning agents. The impact will need to be assessed for each individual change.