Cleanroom Audit: Ensuring Hygiene, Safety, and Process Discipline

A Garment Cleanroom Audit helps you evaluate how well your team follows approved procedures for gowning, garment maintenance, and cleanroom behavior. Cleanrooms rely on strict hygiene practices, controlled environments, and disciplined workflows. Even a small lapse in garment handling can introduce contamination that affects product quality, customer safety, and regulatory compliance.

The goal is simple: keep contaminants out, protect sensitive products, and maintain a stable, compliant cleanroom environment.

What Is a Garment Cleanroom Audit?

A Garment Cleanroom Audit is a structured inspection that reviews how employees use, store, maintain, and replace cleanroom garments. It checks whether gowning practices follow your SOPs, industry standards, and regulatory requirements such as ISO 14644, GMP guidelines, and customer specifications.

The audit focuses on:

• Cleanliness of garments

• Correct gowning techniques

• Integrity and condition of clothing

• Cross-contamination risks

• Overall behavior inside the cleanroom

This audit protects your cleanroom from preventable contamination.

Why Garment Audits Matter

Cleanroom garments act as the primary barrier between personnel and the controlled environment.
A strong garment audit program helps you:

• Reduce particle contamination

• Improve product safety

• Protect sterile or sensitive processes

• Meet ISO, GMP, FDA, and customer requirements

• Build discipline in gowning rooms and controlled areas

• Prevent repeat deviations or contamination events

Most contamination incidents start with human behavior. Garment audits help you detect and correct these issues early.

Key Areas Reviewed in a Garment Cleanroom Audit

A high-quality audit examines every step of the gowning and cleanroom behavior process.
The Lyons Quality Assurance Tracking System audit typically covers:

1. Gowning Room Cleanliness & Setup

• Floors, walls, and surfaces are clean

• Segregation between “dirty” and “clean” zones

• Clear signage for gowning order

• Proper waste disposal and sanitizer availability

A clean gowning area supports a clean cleanroom.

2. Availability & Condition of Garments

Audit checks whether garments are:

• Clean and ready for use

• Stored properly (covered, elevated, or in secure bins)

• Free from tears, linting, stains, or wear

• Correct size and type for the cleanroom classification

Poor garment condition increases contamination risk.

3. Gowning Procedure Compliance

The most critical step of the audit.
Inspectors check if employees:

• Follow the step-by-step gowning sequence

• Avoid touching the floor or unclean surfaces

• Use gloves correctly

• Wear masks, hoods, shoe covers, and goggles as required

• Seal garments properly (zippers, snaps, cuffs)

Any deviation here can compromise product integrity.

4. Behavior Inside the Cleanroom

Auditors observe whether staff:

• Move calmly to reduce particle shedding

• Avoid unnecessary conversation or movement

• Prevent touching of face, hair, or unauthorized surfaces

• Follow approved workflows and material handling steps

Human behavior is the top cause of cleanroom contamination.

5. Garment Removal & Disposal

Improper removal (degowning) can release particles back into the environment.
The audit checks:

• Safe removal sequence

• Proper disposal of single-use items

• Correct return of reusable garments

• Clean placement of used garments in designated bins

6. Garment Laundry & Replacement

A cleanroom audit also reviews how garments are maintained:

• Washing cycles meet cleanroom standards

• Garments are replaced at defined intervals

• Laundry service complies with ISO and GMP requirements

• Tracking (RFID, barcode, or batch logs) is accurate

This ensures garments stay effective as contamination barriers.

Common Findings in Garment Cleanroom Audits

Organizations often uncover issues such as:

• Touching unclean surfaces during gowning

• Torn or aging garments still in circulation

• Incorrect use of gloves or masks

• Garments trailing on the floor

• Poor segregation of clean/dirty zones

• Missing signage or unclear instructions

• Lack of training or refreshers for operators

The right audit helps you correct these issues before they impact the cleanroom.

How Lyons Quality Assurance Tracking System Supports Cleanroom Garment Audits

Using the Lyons Quality Assurance Tracking System, teams can run cleanroom garment audits with consistency and precision.

Key advantages:

• Easy-to-use digital checklist

• Photo evidence and non-conformance tracking

• Real-time issue capture

• CAPA assignment to responsible teams

• Full audit trail for compliance

• Trend reports to detect repeat issues

You can run audits daily, weekly, or per shift to maintain cleanroom discipline at all times.

Conclusion

A Garment Cleanroom Audit protects your cleanroom from human-based contamination risks. By checking gowning techniques, garment condition, cleanroom behavior, and garment handling processes, you ensure a safe and compliant environment. With the Lyons Quality Assurance Tracking System, audits become faster, more accurate, and more traceable—helping your team maintain world-class cleanroom standards.