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By Steve Gonzales

Steve Gonzales, vice president of Technical Safety Services, outlines some essential do’s and don’ts for medical device cleanroom best practice.

The cleanroom remains one of the most important tools in combatting contamination and maintaining safety and quality in medical device manufacturing. All too many facilities, however, fall victim to unexpected contaminants and outbreaks, despite what they took to be their best efforts.

Contaminant control is never more important than in this critical field, where health and even lives can be put at risk by unknown or unacceptable contaminant levels in a medical product or device. Here, we’ll look at some of the most effective methods that medical device manufacturers are using to take the next step in keeping cleanrooms and facilities free of contamination incidents and outbreaks.

  • Don’t: Don’t assume that surface cleaning is sufficient. In highly sensitive fields such as medical manufacturing, the threat of contaminants is not limited to those from working surfaces. Airborne contaminants can land on sensitive equipment or products — and are difficult, if not impossible, to address through traditional surface-focused cleaning and disinfecting methods.
  • Do: Use cleanroom fogging to destroy airborne contaminants, in supplement to surface cleaning. In scenarios where contaminants must be tightly controlled, cleanroom fogging should be regularly used to rid the air of unwanted particles and further reduce the risk of contamination. In conjunction with surface cleaning and proper personnel protocols, this step can vastly reduce contamination incidents.
  • Don’t: Don’t forget to research the strengths and weaknesses of fogging media. Once you’ve made the decision to undertake cleanroom fogging, it is time to decide based on the nature of your facility, products and cleaning requirements. Different fogging media have different qualities, and some may or may not be appropriate for your application.
  • Do: Know the difference between fogging methods. Typical fogging media includes standard chemical disinfectants, ozone, vaporized hydrogen peroxide, chlorine dioxide and more. In addition, no-contact methods such as UV light are available. Each method has different environmental requirements, cycle times, safety considerations and specialised efficacies.
  • Don’t: Don’t leave chemical fogging residue in the cleanroom. Most fogging methods (aside from UV light) will use some type of particulate matter that kills or neutralises airborne contaminants. Throughout the fogging process, these particles will settle onto cleanroom surfaces, leaving a residue that can pose a further risk to processes.
  • Do: Include a final residue removal step after fogging. As a final step after fogging, conduct a wipedown of all cleanroom surfaces to remove this residue and maintain safe working areas.
  • Don’t: Don’t get surprised by hidden contaminants, such as fungi and mould. Fungi and mould are among the most insidious contaminants that can attack the cleanroom. They reproduce easily and can come from nearly any source or location — including those that aren’t reached by standard surface cleaning and disinfection. There have even been reports of contamination and outbreak occurring from personnel who have followed all protocol but have a case of fungal infection such as athlete’s foot.
  • Do: Test the facility for fungi and take steps to combat it. The facility and surrounding areas should be regularly tested for mould spores and fungus, using standardised and approved processes — which will usually run beyond a simple off-the-shelf mould tester. The severity of a mould outbreak — which can be incredibly difficult to reverse and can lead to an extended facility shutdown — more than justifies the resources for this testing.
  • Don’t: Don’t rely on standard cleaning or disinfecting alone to combat fungi. Moreover, mould and fungi can be resistant to standard cleaning methods, and even more powerful disinfectants.
  • Do: Use sporicides as necessary. Thus, be sure to incorporate sporicides and other, more specialised cleaning media into your protocols as necessary, to help ensure you are using the correct methods to combat every possible source of contamination.

With these tips at your side, you are now ready to take next-level steps in guarding against more advanced types of contamination, such as airborne particles and fungi. These practices are an integral part of the vast responsibility in medical device manufacturing.

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