ChemoSure: A Next‑Generation Wipe Sampling Solution for USP <800> Compliance

The Critical Role of Surface Monitoring under USP <800>

USP General Chapter <800> sets rigorous expectations for the handling of hazardous drugs (HDs), with the goal of protecting healthcare workers, patients, and the environment from exposure. One of its key elements is environmental quality and control, which includes surface sampling (wipe testing) to verify that decontamination, cleaning, and containment strategies are effective.

Because USP <800> does not prescribe acceptable absolute thresholds for HD residues, the presence of detectable contamination often triggers root cause investigations and remediation. In practice, surface wipe sampling is widely accepted as a benchmark and should be performed at baseline and at least semiannually or more frequently depending on risk and monitoring history.

However, a persistent challenge in HD environmental monitoring is complexity: multiple analytes, solvent compatibility, sample logistics, and result turnaround all can make implementation burdensome. That’s where ChemoSure enters the picture.

What Is ChemoSure?

ChemoSure is a wipe sampling kit developed by Eurofins Built Environment Testing in Richmond, VA, designed for surface residue monitoring of hazardous drugs to support USP <800> compliance.

Key features and differentiators:

• Single‑swab, broad‑spectrum method: Uses a 50/50 methanol/water wetting solution and a single swab to sample a 100 cm² area, while being compatible across multiple drug classes (including platinum compounds).
• Wide analyte coverage: Detects 19 hazardous drugs, each reported individually—including cisplatin, oxaliplatin, and carboplatin (differentiated).
• Comprehensive kit: Each sampling kit includes:
  The wetting agent (50/50 methanol/water)
  • The swab(s) and a 100 cm² sampling template
  • Test tube vials
  • Chain-of-Custody (COC) documentation
  • Prepaid FedEx return shipping label
• Ease of workflow: Because ChemoSure uses one swab per sample location and includes clear instructions, it streamlines sampling logistics and staff training.

By combining broad analyte compatibility, operational simplicity, and logistical completeness, ChemoSure helps reduce barriers to routine HD surface monitoring in healthcare settings.

Technical Advantages & USP <800> Alignment

Let’s explore how ChemoSure’s features align with the needs of HD environmental monitoring and USP <800> expectations:

1. Broad Compatibility & Platinum Differentiation
   Many wipe sampling protocols require separate swabs or solvents for different drug classes. ChemoSure’s optimization with a 50/50 methanol/water matrix supports wide analyte compatibility in one sampling pass. Moreover, its ability to differentiate individual platinum-based drugs (cisplatin, carboplatin, oxaliplatin) is a notable value-add compared to methods that lump platinum species together.
2. Single‑Swab Workflow & Reduced Complexity
   Using one swab per location simplifies chain‑of‑custody paperwork, lowers handling error potential, and lessens training burden—especially helpful when multiple staff or locations are being sampled.
3. Turnkey Sampling Logistics
   By providing all necessary materials (swab, template, solvent, vial, COC, prepaid shipping), ChemoSure ensures uniform sampling methodology and avoids delays or omissions. Logistical weaknesses often delay or degrade wipe programs; ChemoSure’s completeness is a practical differentiator.
4. Data Traceability & Documentation
   The built‑in chain‑of‑custody and controlled shipping package support rigorous QA oversight, audit readiness, and trendable data over time.
5. Support for Routine Sampling Strategy
   ChemoSure is especially well-suited for the baseline / semiannual sampling strategy commonly used in HD environmental monitoring:

• Establish an initial benchmark across sentinel locations
• Monitor over time to detect upticks or anomalies
• Use deviations to trigger root cause analysis and corrective actions

Because ChemoSure lowers the friction of sampling execution, organizations are more likely to maintain consistent monitoring rather than sporadic testing.

How ChemoSure Solves the Monitoring Burden

Imagine a hospital compounding pharmacy struggling to sustain regular surface monitoring because assembling materials and coordinating shipping becomes a burden. With ChemoSure:

• Each sampling location is provided with a self-contained kit.
• Technicians follow included instructions, label their sample, drop it off for FedEx pickup, and send it to the lab.
• The lab delivers concentrations per analyte, including distinguished platinum species.
• Leadership reviews results across cycles, locates hotspots, refines cleaning or engineering controls, and tracks improvements.

Because the sampling burden is lower, the site is more likely to maintain compliance consistency and generate useful trend data rather than doing “one-off” measurements.

Potential Limitations & Considerations

While ChemoSure offers many advantages, users should note:

1. Analytical Sensitivity & Reporting limit
   Even robust wipe methods are bounded by the reporting limits and recovery efficiencies of the laboratory method. In very well-controlled facilities, residual levels may fall below detection thresholds.
2. Surface Material Effects
   Different surface materials (stainless steel, plastics, glass) may influence recovery. Consistency in sampling technique is critical (wetting, pressure, swab rotation).
3. Absence of Absolute Safe Limits
   USP <800> doesn’t mandate numeric safe thresholds. Interpretation must rely on each facility’s history, trends, and root cause analysis.
4. Cost Considerations
   Institutions must budget for periodic sampling. The reduced complexity of ChemoSure mitigates “hidden” personnel time or kit assembly costs, but the per-sample cost remains a factor.

ChemoSure addresses a long-standing challenge in hazardous drug monitoring: making regular, reliable surface sampling more practical and less error-prone. With its expansive analyte panel (including platinum differentiation), single‑swab design, and all-in-one kit logistics, it empowers EHS, pharmacy, and compounding teams to run consistent USP <800> monitoring programs.

For organizations dedicated to worker safety and continuous improvement, ChemoSure offers a streamlined path to repeatable, actionable environmental monitoring.

Move from complex sampling to actionable data. Contact us today to learn more about ChemoSure and to order your kits now.