Did know that USP 800 hazardous drug compounding and safe handling standards become enforceable on November 1, 2023? Are you prepared to meet the standards outlined within USP 800? In this blog post, I’m going to address one element of USP General Chapter 800 – Section 6 which deal with “Environmental Quality & Control.” This is one specific area where using the ChemoGLO Wipe Kit is an easy way to establish and maintain compliance. But before we go into more detail about the Wipe Kits, here’s some information about Section 6:
Standards Established in Section 6, USP 800: Environmental Quality & Control
USP 800 and the National Institute for Occupational Safety and Health (NIOSH) recommends that employers develop a medical surveillance program to monitor the safety of the employees working with hazardous drugs. This recommendation includes using baseline data and ongoing monitoring of environmental hazards as a way to assess the potential risk of employee exposure to hazardous drugs. Here are a few of the standards established in USP General Chapter <800> Section 6:
• Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment).
• Wipe sampling kits should be verified before use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from various surface types found in the sampled area.
• If any measurable contamination is found, the designated person must identify, document, and contain the cause of contamination. Such action may include reevaluating work practices, re-training personnel, performing thorough deactivation, decontamination, cleaning, and improving engineering controls.
• Wipe sampling should be repeated to validate that the deactivation/decontamination and cleaning steps have been effective.
When it comes to compliance with USP 800 standards, it is important to leverage the best resources available. Using the ChemoGLO Wipe Kit is the easiest, fastest, and most reliable way to get quantitative data on potential hazardous drug exposures at baseline and for ongoing risk assessments. The ChemoGLO Wipe Kit is the most widely used wipe contamination kit in the United States. A single kit can measure 24 separate drugs (17 hazardous and 7 hormone drugs) at the same time and provide quantitative results within 3-5 business days.
A complete kit contains enough materials to test in six wipes. An easy-to-follow User Manual is included in every kit, and our Wipe Kit "How To" video offers step-by-step instructions. Once you've completed your testing, samples are sent back to the ChemoGLO laboratory facility for analysis. Within 3-5 business days, a professional and customized report of exposure concentrations will be sent to you via email.
Here are some other advantages offered by ChemoGLO’s Wipe Kits:
• All samples are shipped at room temperature; no refrigeration or dry ice required.
• The ChemoGLO assay has a very low limit of quantitation for each drug (10 ng/ft2) and a very high limit of quantitation for each drug (4000 ng/ft2) which allows for a wide range of detectable concentrations per drug.
• A detailed report, provided via email, shows the results for each individual institution compared to previous wipe studies at that institution to form a chronological comparison of results.
• In addition, the report compares the current wipe results for that institution to the thousands of historical ChemoGLO wipe sample results so that each institution can have a relative comparison of exposure concentrations that will assist in making a risk assessment determination.
• The founders of ChemoGLO, LLC are experts in their fields and understand the issues and concerns with chemotherapy formulations, pharmacy operations, and monitoring.
To order ChemoGLO products or arrange to speak with one of our experts, please email our sales group at orders@chemoglo.com or call 1-877-215-2705 ext. 2.