The main objective is to ensure that the medical device or its components are clean to a defined and acceptable levelbefore sterilization or use. The organization must control and maintain cleanliness throughout production to prevent contamination that could affect device safety, performance, or sterility.

This clause applies when:

• The product is cleaned before sterilization or use.

• The product is supplied non-sterile and must be cleaned before use or sterilization.

• The product is intended to be sterilized by another party or the end user.

• Cleanliness is critical to the product’s function or performance (e.g., implants, optical devices, catheters).

This clause applies when:

• The product is cleaned before sterilization or use.

• The product is supplied non-sterile and must be cleaned before use or sterilization.

• The product is intended to be sterilized by another party or the end user.

• Cleanliness is critical to the product’s function or performance (e.g., implants, optical devices, catheters).

Documented requirements define how clean a product must be for it to be safe and functional. This includes measurable criteria such as particulate limits, bioburden levels, and residue levels, along with specific methods, cleaning agents, and acceptance criteria used to achieve and verify those standards.

A cleaning process must be validated to ensure it consistently achieves the defined cleanliness level. Validation involves confirming the cleaning parameters (temperature, concentration, duration, water quality, and equipment type), verifying residue removal, and maintaining records of validation and periodic revalidation.

Cleanliness is ensured through controlled environments (cleanrooms or controlled areas), approved cleaning materials, operator gowning procedures, and environmental monitoring. Regular cleaning of production areas, tools, and equipment is also required to maintain consistent cleanliness levels.

Common contaminants include particulate matter (dust, fibers), microbial contamination (bacteria, fungi), and chemical residues (detergents, oils, adhesives). These contaminants can affect device performance or patient safety if not controlled.

Auditors typically review:

• The cleanliness specifications in product or process documentation.

• Validation evidence for cleaning processes.

• Records of cleaning activities and inspection results.

• Environmental controls in clean areas.

• Labeling and IFUs for non-sterile products.

 

They may also verify that training, segregation, and maintenance practices are effectively implemented.

Typical findings include:

• Lack of validated cleaning procedures.

• Inadequate cleanliness specifications or undefined acceptance limits.

• Poor segregation between cleaned and uncleaned items.

• Missing or incomplete cleaning records.

• Contamination found during final inspection or environmental monitoring.

ISO 13485 Clause 7.5.2 focuses on cleanliness before sterilization, ensuring the product surface and components are free of contaminants that could interfere with sterilization effectiveness. Clause 7.5.5 deals with validation and control of the sterilization process itself. Both are critical for ensuring final product safety.