Reusable Device Cleaning Validation

Cleaning validation is a required activity for reusable medical devices to demonstrate that defined cleaning processes consistently remove soils and contaminants to levels acceptable for subsequent sterilization. Within Life Science Outsourcing’s Sterilization Validation Services (SVS) division, cleaning validation is performed to support regulatory compliance, reprocessing effectiveness, and documented sterility assurance for reusable instruments and implants.

SVS provides cleaning validation services aligned with applicable regulatory and standards-based requirements for reusable medical devices.

What Is Cleaning Validation?

Cleaning validation is the documented process of establishing and confirming that a defined cleaning procedure effectively removes organic and inorganic residues from a reusable medical device under worst-case conditions.

Cleaning validation provides objective evidence that cleaning parameters, methods, and acceptance criteria are suitable to support subsequent sterilization and safe reuse.

Who Needs Cleaning Validation?

Cleaning validation is required or commonly performed by:

Medical device manufacturers producing reusable instruments or non-sterile implants
Medical device startups developing reusable products for regulatory submission
OEMs scaling reusable products into commercial manufacturing
Manufacturers defining or updating reprocessing instructions
Quality and regulatory teams responsible for validation documentation and compliance

Cleaning requirements are determined by device design, materials, use conditions, and regulatory expectations.

How Does Cleaning Validation Work?

Cleaning validation within SVS generally includes:

Review of device design, materials, and intended use
Identification of worst-case devices, features, and contamination scenarios
Definition of cleaning parameters, agents, and methods
Execution of cleaning validation studies using defined protocols
Analytical testing to assess cleaning effectiveness
Generation of validation documentation suitable for regulatory use

Testing activities may be performed using SVS in-house laboratory capabilities and qualified partner laboratories, as appropriate.

Relationship to Reprocessing and IFU Development

Cleaning validation data are used to support:

Definition of validated cleaning parameters
Development or confirmation of reprocessing instructions
Documentation included in reusable device Instructions for Use (IFU)

Validated cleaning processes help ensure consistency between documented instructions and achievable reprocessing outcomes.

What Standards Apply?

Cleaning validation services within SVS align with applicable regulatory and standards-based requirements, including:

ISO 17664 — Processing of health care products (information to be provided by the manufacturer)
ISO 17665 — Moist heat sterilization
ISO 11737 — Bioburden and sterility assurance
ISO 10993 — Biological evaluation of medical devices (as applicable)
FDA Quality System Regulation (21 CFR Part 820)