The use of Contec® Critical Site® Sterile Wipes presaturated with 70% IPA has become common practice for disinfecting entry points of sterile packages and devices.
However, questions arise regarding the number of critical sites that can be wiped using a single wet wipe. In this blog post, we will explore this topic and provide insights from industry experts, clarifying the guidelines and addressing potential confusion surrounding the use of critical site wipes.
The revised chapter does not explicitly address the specific number of critical sites that can be wiped using a single wet wipe. However, industry experts tell us if the wipe is wet and effectively wets the target site, it is permissible to use a single wipe on multiple critical sites. Remember that the relative bioburden on critical sites should be very low.
To fully grasp the context of this question, it is essential to recognize the confusion caused by some language contained in the 2008 version of USP Chapter <797>. This language stated that the “surface of the sterile 70% IPA swabs used for disinfecting entry points of sterile packages and devices shall not contact any other object before contacting the surface of the entry point.” Certain accreditation companies interpreted that language to mean the use of a separate wipe for each site was required. That language was removed and so does not appear in the new version of USP <797> initially published 11/1/2022.
When seeking clarification on the use of critical site wipes, it is valuable to consult with Contec Healthcare experts, who specialize in providing contamination control solutions. Multiple critical sites can be effectively wiped using a single wet wipe. The key factor is ensuring that the wipe remains adequately wet throughout the process to maintain its efficacy. Each site must be wiped vigorously in one direction to ensure the chemical action of the alcohol as well as secure the mechanical action of the wipe to move any existing bioburden off the site to reduce the risk of contamination. While wiping multiple critical sites with a single wet wipe is acceptable, sites must be allowed to dry before proceeding.
It is important to use sterile Critical Site Wipes correctly to achieve critical preparation that effectively reduces the risk of microbial contamination. While the revised chapter does not quantify the number of critical sites that can be wiped with a single wet wipe, industry experts confirm that multiple sites may be wiped provided the wipe remains wet and effectively wipes the target surface. Understanding the historical context, seeking expert perspectives, and ensuring proper drying before puncture are crucial to maintaining proper asepsis.