Cleaning Validation Solutions

Cleaning Validation Capabilities

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

01

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.

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02

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.

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03

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.

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04

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.

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Meet our Cleaning Validation Solutions Experts

Dr. Michelle Wall, PhD

MANAGER, ENGINEERING SOLUTIONS

Helpful Links

Here are some of our favorite resources on this topic

FDA PART 211

CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart D – Equipment Sec. 211.67 Equipment cleaning and maintenance

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Markets That Benefit from Our Cleaning Validation Solutions

Combination Products

Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.

Biologics

We understand why “the product is the process” and how to implement solutions to your unique challenges.

Pharmaceuticals

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

Other

Our diverse experience across the life science industry, including medical device and vaccines, ensures your challenges are in expert hands.

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.

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.

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.

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.

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.