A cleanroom is a controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out to provide the cleanest area possible. Cleanrooms are essential in industries such as pharmaceuticals, biotechnology, semiconductor manufacturing, and medical device production where contamination can compromise product quality, safety, and compliance with regulatory standards like ISO 14644 and GMP.
Cleanrooms are classified according to ISO 14644-1 standards based on the number of particles per cubic meter of air. The main classifications range from ISO Class 1 (cleanest) to ISO Class 9. Common classes include:
- ISO Class 5 — 3,520 particles of 0.5 micrometers per cubic meter, used for sterile pharmaceutical production
- ISO Class 7 — 352,000 particles, suitable for electronics assembly
- ISO Class 8 — 3,520,000 particles, for general manufacturing applications
Each class determines the type of filtration, airflow, and equipment required for compliance.
HEPA filters typically need replacement every 2-3 years under normal operating conditions. However, the actual replacement schedule depends on several factors: operating hours, contamination levels in the environment, pre-filter maintenance, and pressure differential monitoring.
Regular testing per ISO 14644-3 standards and maintaining pressure differential logs help determine when filters are approaching their end of life. Signs that replacement is needed include increased pressure drop across the filter, reduced airflow, or failed particle count tests.
A modular cleanroom is a prefabricated, customizable cleanroom system built using standardized panels and components that can be assembled on-site. Benefits include:
- Faster installation (typically 50-70% quicker than traditional construction)
- Lower total cost of ownership
- Flexibility for reconfiguration or relocation
- Minimal disruption to existing operations
- Scalability to expand as needs grow
- Compliance with ISO 14644 standards
Modular cleanrooms are ideal for companies needing quick deployment or anticipating future changes in space requirements.
An air shower is a decontamination chamber placed at cleanroom entry points. It uses high-velocity, HEPA-filtered air jets to blow off loose particles from personnel, equipment, and materials before they enter the controlled environment.
Air showers typically feature interlocked doors that prevent both doors from opening simultaneously, maintaining pressure differentials and preventing contamination. They are essential for ISO 5-8 cleanrooms and significantly reduce particle counts introduced by human movement.
A Fan Filter Unit (FFU) is a compact, self-contained device mounted in the ceiling that draws air through a HEPA filter and distributes filtered air into the cleanroom. It handles local air filtration and circulation.
An Air Handling Unit (AHU) is a larger central system that conditions outside air (heating, cooling, humidifying) and distributes it through ductwork to multiple zones.
In cleanroom HVAC, FFUs and AHUs work together: AHUs provide conditioned makeup air while FFUs provide the high volume of filtered recirculated air needed to maintain cleanliness levels.
Choosing the right cleanroom equipment involves several key considerations:
- Determine your required ISO classification based on your application and regulatory requirements
- Assess your space constraints and whether a modular or traditional build is more suitable
- Calculate your airflow requirements based on room volume and desired air changes per hour (typically 10-20 for ISO 8, up to 500+ for ISO 5)
- Consider your budget including initial investment and operating costs
- Consult with a cleanroom specialist like Hansen Cleanroom who can provide a comprehensive assessment and customized solution
Hansen Cleanroom products and solutions comply with multiple international standards including:
- ISO 14644 — Cleanrooms and associated controlled environments
- CE marking — European market access
- UL certification — Electrical safety standards
- RoHS compliance — Environmental standards
- GMP — Good Manufacturing Practice for pharmaceutical applications
- FDA requirements — Where applicable
All products undergo rigorous quality control testing before shipment, and we provide complete documentation and certificates of compliance with each order.
Standard lead times for Hansen Cleanroom equipment range from 7 to 15 working days for most products including FFUs, air showers, and pass-through boxes. Modular cleanroom systems typically require 15-25 working days depending on customization complexity and project scale.
For large or highly customized orders, lead times may extend to 4-6 weeks. We also offer expedited production for urgent projects. Please contact our sales team for specific delivery schedules based on your requirements.
Yes, Hansen Cleanroom provides comprehensive support throughout the entire project lifecycle. Our services include:
- Free consultation and cleanroom design
- Detailed installation guidance and documentation
- Optional on-site installation supervision
- Commissioning and certification testing
- Operator training programs
- 24-month warranty on all equipment
- Ongoing technical support via phone, email, and video consultation
We also maintain a global inventory of spare parts to ensure rapid response for any maintenance needs.
