Cleanliness Testing in
Medical and
Food Applications

"How Clean Is My Product?"

It is relatively easy to pose the question “how clean is my product?" However, this apparently simple question frequently involves substantial testing and requires an intimate understanding of cleaning process, material behavior and regulatory requirements.

For a start, it is virtually impossible to guarantee a completely residue free device or package, and in the cases where that is possible, it is rarely cost-effective. Determining levels of contaminants in food and medical packaging is critical for regulatory clearance and consumer safety, but is rarely trivial. The problem is even more complex when one is considering medical implant cleanliness, either directly, or as a result of quality control efforts on clean-lines.

Critical Cleanliness Elements

Critical elements that must be considered are (by no means exhaustive):

  • End use
  • Potential residues
  • Acceptable residue concentrations
  • Potential change products
  • Storage conditions
  • Available methods for determination of residues, and their respective detection limits
  • Desirable statistics in “proving” the defined levels.
  • Design restrictions (potential blind holes and locations where residues may not be easily accessed)

It is important in medical devices that not only the potential residues be determined, but that a coherent and rational argument is used to define acceptance criteria a priori.

CPG has extensive experience in determining the most relevant tests for elucidation of levels of contaminants, and the levels that are reasonable in a particular application. Through our work with ASTM, we are developing standards for cleanliness assessment of medical implants, cleanliness validation, and design of components for easy cleaning. Through our fundamental chemistry expertise we also have a strong understand of polymer and packaging additives that may become a leachable species or another potential source of residues. We also provide testing for plastics that will be in contact with food.

Please contact us if you require further information, or review the more specific list of topics to the left. You may also find some of our case studies and application notes of interest (see right side bar). In addition, our academic and educational seminars may provide more information.