USP <797> Compliance: A Guide to Proper Donning of Garb for Sterile Compounders

USP <797> Final Revisions and Implementation Timeline

The revised USP <797> chapter was published on November 1, 2022, with an official implementation date of November 1, 2023.

Facilities must use this transition period to:

• Review revised language
• Assess their physical layout
• Update SOPs
• Train personnel accordingly

Garbing procedures must align with the final chapter’s updated expectations.

Regulatory Language: Facility-Determined Garbing Order

Section 3.2 of the revised chapter states that the order of hand washing and garbing depends on the placement of the sink.

Section 3.3 further clarifies that:

• Required garb
• Storage practices
• Order of garbing

This represents a shift toward facility-specific procedural responsibility rather than a one-size-fits-all sequence.

The Role of Sink Placement in Garbing Sequence

Sink placement directly impacts garbing order because hand hygiene must occur at an appropriate stage relative to crossing the line of demarcation (LOD) between dirty and clean areas.

The presenter stresses that physical layout determines workflow. Therefore, facilities must evaluate their sink location when establishing compliant garbing procedures.

Five Common Sink Placement Scenarios

The webinar outlines five common scenarios involving sink location:

1. Cleanroom sink located on the clean side of the line of demarcation
2. Cleanroom sink located on the dirty side of the line of demarcation
3. Cleanroom suite with sink located outside the cleanroom
4. Segregated Compounding Area (SCA) with sink inside the room
5. SCA with sink located outside the room

Each scenario requires thoughtful evaluation to ensure proper sequencing of handwashing and garbing to minimize contamination risk.

Cleanroom Suite Scenarios

In cleanroom suites, sink location relative to the line of demarcation significantly influences workflow.

If the sink is:

• On the clean side: hand hygiene and garbing must align with controlled area entry procedures.
• On the dirty side: personnel must consider when to perform hand hygiene before crossing into cleaner areas.
• Outside the suite: additional procedural controls may be needed before entering the cleanroom environment.

The emphasis is on preventing contamination transfer across the demarcation line.

Segregated Compounding Area (SCA) Scenarios

For SCAs, sink location inside or outside the compounding room changes the garbing sequence.

Facilities must determine:

• When hand hygiene occurs
• When garb is donned
• How to prevent contamination from flowing into the SCA

Because SCAs have different environmental controls than full cleanroom suites, workflow must be clearly defined and documented.

Documentation and SOP Requirements

USP <797> requires that facilities:

• Determine their specific garbing order
• Document it in SOPs
• Ensure consistency in practice

Regulators will expect written procedures that align with physical layout and actual workflow.

Garbing order is no longer assumed—it must be justified and documented.

Best Practice Considerations for Contamination Control

Throughout the discussion, contamination control remains the guiding principle.

Best practices include:

• Aligning garbing sequence with sink placement
• Protecting the clean side of the demarcation line
• Ensuring proper storage of garb
• Training staff on facility-specific procedures
• Conducting regular audits for compliance

The webinar reinforces that personnel are the largest contamination source, making garbing sequence critical.