Primer for Success: Expert Q&A Panel

Cleanroom Design Questions (Anteroom & Sink Placement)

One discussion focuses on wet anteroom design, particularly whether it must be ISO-classified.

Key takeaways:

• Wet anterooms do not necessarily need to be ISO-classified

• They may function as controlled but unclassified (CNC) spaces

• Sinks can also be located outside classified areas

However, making the space ISO-classified may provide advantages, such as keeping water out of higher-classification areas.

HEPA Filter Integrity and Certification Requirements

The panel addresses questions about HEPA filter integrity testing.

Key points:

• HEPA integrity testing is part of routine certification

• It must be performed at least every six months

• Testing is conducted by certification professionals

Facilities are responsible for ensuring certification occurs—not for performing the tests themselves.

Technical Considerations in Certification Testing

The discussion includes technical aspects of certification testing, such as:

• Aerosol challenge testing for HEPA filters

• Proper setup for accurate testing results

These technical details highlight the complexity of certification processes and the need for qualified professionals.

Equipment Setup and Testing Parameters

A specific question addresses aerosol injection port placement.

Insights include:

• Injection ports can be placed at significant distances (e.g., up to ~45 feet or more)

• Tubing size and system setup influence effectiveness

• Proper configuration is critical to achieving valid test results

This reinforces that testing is both technical and highly dependent on setup conditions.

Clarifying Responsibilities: Facility vs. Certifier

A key clarification is the division of responsibilities:

• Facilities → Ensure certification is scheduled and completed

• Certifiers → Perform testing and validation

Facilities should not attempt to perform specialized certification tasks without proper expertise.

Practical Interpretation of USP Requirements

The panel helps interpret USP standards in practical terms, emphasizing:

• Flexibility in design (e.g., sink placement)

• Importance of meeting intent, not just letter of the regulation

• Real-world application of standards

This helps bridge the gap between regulatory text and operational implementation.

Key Themes from Audience Questions

Recurring themes across questions include:

• Cleanroom design flexibility

• Certification requirements and frequency

• Technical details of testing procedures

• Roles and responsibilities in compliance

These reflect common areas of confusion and focus for pharmacy teams.