ISO Cleanroom Cleaning Standards
Maintaining compliance with ISO 14644-1 requires a technical cleaning methodology that is specific to the classification of your controlled environment.
Cleanrooms are defined by the concentration of airborne particles, ranging from ISO Class 1 (cleanest) to ISO Class 9 (comparable to room air). As the class number decreases, the tolerance for contamination drops exponentially, demanding more rigorous cleaning frequencies, specialized chemistry, and non-shedding materials.
CleanTech Facility Services provides validated cleaning protocols designed to ensure your facility consistently meets its ISO targets during both "at-rest" and "operational" states.
Class 1-9 Expertise
Tiered protocols matching the stringent requirements of every ISO class.
Validated Methods
Cleaning frequencies and techniques documented for audit compliance.
HEPA Technology
Use of Class-approved vacuums and specialized filtration equipment.
Defining the Standard
Under ISO 14644-1, the facility must be cleaned using methods that do not introduce more particles than they remove. Our technical approach includes:
- Top-down cleaning (Ceiling to Walls to Floors)
- Overlapping linear strokes (unidirectional mopping)
- Validated dwell times for sterile and non-sterile agents
- Microfiber materials with < 0.1 micron particle shedding
Regulatory Compliance
- ISO 14644-5: Cleanroom Operations
- ISO 14644-2: Monitoring and Testing
- USP <797> / <800> Pharmacy standards integration
- FDA cGMP (Current Good Manufacturing Practice) alignment
Specialized Cleaning Protocols
We provide structured cleaning schedules that are customized to your specific cleanroom classification and operational workflow.
Daily & Weekly Maintenance
Routine cleaning focuses on high-touch surfaces, floors, and entry zones. We use Class-approved disinfectants and sanitized mopping systems to maintain the daily particulate baseline without disrupting ongoing operations.
Deep Cleaning & Periodic Re-Validation
Monthly or quarterly deep cleans address walls, ceilings, and difficult-to-reach areas. This phase often precedes official particulate re-testing and includes the removal of residue from previous cleaning agents (stripping and rinsing).
Non-Shedding Supplies & Equipment
Standard janitorial supplies are a primary source of contamination. We utilize specialized cleanroom-grade equipment, including low-linting polyester wipes, dual-bucket mopping systems, and HEPA-filtered vacuums that are dedicated to specific ISO zones.
Service Standards
- Documented training protocols
- Sterile/Non-sterile agent options
- Audit-ready documentation
- Class-appropriate gowning
Compliance Strengths
- Reduced yield loss from particles
- Minimized legal/regulatory risk
- Consistent audit performance
- Long-term facility health
Protecting the Critical Environment
In an ISO-certified environment, your facility's cleanliness is a measurable technical specification. CleanTech Facility Services provides the expertise and discipline needed to maintain that specification, protecting your product, your patients, and your reputation.
Request an ISO Compliance Audit
Does your current cleaning program meet ISO 14644-1 requirements? Contact us for a technical audit of your cleaning protocols and supplies.
SCHEDULE AN ISO AUDITNeed Help Maintaining Your ISO Class Compliance?
CleanTech Facility Services provides the technical discipline your controlled environment requires.