Cleanovators 2025 Panel Q&A

Surface Wipe Sampling Beyond the PEC

One key discussion centers on whether to perform wipe sampling outside the Primary Engineering Control (PEC).

Key insight:

• Even if not explicitly required, sampling outside the PEC is highly valuable
• It provides visibility into contamination spread beyond controlled zones

High-Touch Areas and Hidden Contamination Risks

Experts highlight high-touch areas as critical sampling points, including:

• Storage and staging areas for compounded products
• Doorknobs and entry/exit points
• Areas accessed frequently by staff (e.g., nurses retrieving medications)

These areas often show unexpectedly high contamination levels.

Material Handling of Hazardous Drugs Upon Receipt

The panel discusses best practices for handling hazardous drugs (HDs) after receipt.

Key considerations include:

• Evaluating all touchpoints from receiving to storage
• Understanding contamination risks introduced during handling

Material handling is presented as the start of the contamination control process, not just compounding.

Packaging and Decontamination Practices

A common question addresses whether to:

• Keep HDs in manufacturer packaging
• Wipe outer boxes, inner containers, or both

Key takeaway:

• Decontamination should consider all layers of packaging
• Packaging can both contain and spread contamination

Workflow Considerations from Receiving to Storage

The panel emphasizes that contamination control must cover the entire workflow:

• Receiving
• Transport
• Storage
• Preparation
• Administration

Each step introduces potential exposure risks.

Common Gaps in Real-World Practice

The discussion reveals several common gaps:

• Overlooking areas outside the PEC
• Underestimating contamination in high-touch zones
• Inconsistent material handling practices

These gaps often lead to unnoticed exposure risks.

Integrating Best Practices Across the Workflow

Effective contamination control requires:

• Standardized procedures across all workflow stages
• Consistent decontamination practices
• Awareness of contamination pathways

A holistic approach is necessary for meaningful risk reduction.

Key Themes from Audience Questions

Recurring themes include:

• Where to sample for hazardous drug residues
• How to handle materials safely
• How contamination spreads beyond expected areas
• Practical interpretation of USP <800> requirements

These reflect real-world concerns faced by pharmacy teams.