The use of industrial PCs in cleanroom environments presents a unique set of technical and regulatory challenges, requiring careful consideration in the selection and configuration of suitable hardware. At PSB GmbH, our experience spans decades of engineering high-performance computing systems tailored to stringent requirements across various industries, including medical and pharmaceutical sectors. Our approach is rooted in a deep understanding of contamination control, precision manufacturing, and compliance with internationally recognized cleanroom standards. We prioritize robust construction, seamless integration, and advanced filtration concepts to ensure that our solutions meet not just performance, but also hygiene and durability criteria expected in these specialized environments. By engaging closely with our clients, we develop and customize PC systems that excel even in demanding cleanroom scenarios, combining innovation with proven reliability.
What is a Cleanroom? – Definition and Classification
A cleanroom is a controlled environment specifically designed to minimize the introduction, generation, and retention of particles and contaminants. Cleanrooms are crucial in sectors where even microscopic impurities can compromise product quality, such as the semiconductor, pharmaceutical, biotechnology, and food industries. These controlled spaces are rigorously classified according to the quantity and size of particles allowed per volume of air, ensuring strict contamination control. Common standards include ISO 14644 and GMP protocols.
Cleanroom Classes According to ISO 14644
| ISO Class | Maximum Particles ≥0.5μm/m³ | Typical Application |
|---|---|---|
| ISO 1 | 10 | Nanoelectronics, advanced semiconductor manufacturing |
| ISO 5 | 3,520 | Pharmaceutical filling, critical assembly lines |
| ISO 7 | 352,000 | General pharmaceutical and biotech processes |
| ISO 8 | 3,520,000 | Food processing, general industry |
The GMP guidelines (Good Manufacturing Practice) also define cleanroom classifications, emphasizing hygiene and quality control, particularly for pharmaceutical and medical device production. Requirements under GMP focus not only on air cleanliness but also on layout, personnel flow, equipment, and cleaning routines.
Requirements for Industrial PCs in Cleanrooms
Industrial PCs for cleanrooms must satisfy rigorous demands in terms of particle emission, resistance to harsh cleaning, and environmental protection. The choice of enclosure materials—primarily stainless steel—and the technical design directly influence compliance with these criteria. Other critical requirements include:
- IP Protection: High IP ratings (IP65 and above) ensure dustproof and water-resistant capabilities during regular wet cleaning and disinfection.
- Electrostatic Discharge (ESD) Compliance: ESD-tolerant PCs prevent the generation and discharge of static electricity that could damage sensitive electronics or attract particles.
- Fanless Cooling: Fanless PCs reduce turbulence and airborne particle movement, maintaining lower contamination risks.
- Surface Finish: Smooth, sealed surfaces with specified surface roughness (often Ra ≤ 0.8 μm) to prevent microbial and particle accumulation.
- Sealing and Enclosure: Comprehensive sealing to prevent infiltration and accumulation of particles in crevices or seams.
HEPA/ULPA Filtration and Air Management
Cleanroom operations often incorporate HEPA (High Efficiency Particulate Air) or ULPA (Ultra Low Penetration Air) filters to maintain air purity. Proper placement and construction of industrial PCs must not interfere with laminar airflow or the effectiveness of air changes, and the equipment should be designed to allow for unobstructed decontamination and efficient particle monitoring.
Norms and Standards for Cleanroom PCs
- ISO 14644: Provides the international standard for classification of air cleanliness based on particle concentrations.
- GMP: Ensures product quality and safety, especially in pharmaceuticals, with strict guidelines on hygiene and equipment.
- IP Protection: Defines the enclosure’s resistance to dust and water ingress—critical for regular cleaning and disinfection.
- ESD: Standards on electrostatic discharge compatibility to prevent component damage and maintain cleanliness.
Selection Criteria for Cleanroom PCs
The selection of a cleanroom industrial PC system involves more than matching performance specifications; it centers on compliance with cleanroom procedures and industry regulations. The following criteria should be prioritized:
- Material Selection: Stainless steel is favored for its chemical resistance and non-porous, hygienic finish. All surfaces should be corrosion-resistant and withstand aggressive cleaning agents.
- Protection Class: The enclosure’s IP protection level (e.g., IP65/IP69K) ensures no particle or fluid ingress during cleaning or operation.
- Fanless Operation: Fanless systems prevent the spread of airborne contaminants and reduce contamination risks.
- Hygienic Design: Seamless designs with sloped surfaces, round edges, and hidden fasteners further minimize potential sites for microbial accumulation and enable easy cleaning.
- ESD Compliance: Designed to be fully ESD-compliant, safeguarding sensitive components and reducing static-induced particle adhesion.
- Seal Quality: Advanced sealing strategies inhibit ingress of particles and facilitate high-frequency cleaning.
- Interface Design: Touch panels compatible with gloves, minimal physical buttons, and protected I/O ports for easy sterilization are preferred.
Checklist: What to Look for in a Cleanroom Industrial PC
- Compliance with ISO 14644 or GMP cleanroom classification
- Stainless steel housing with polished or brushed finish
- Fanless operation
- High IP protection class (IP65/IP69K)
- Sealed and easy-to-sanitize design
- ESD-tested components and build
- Hygienic cable management and integration
Industry-Specific Examples
| Sector | Required Features | Regulation Reference |
|---|---|---|
| Pharmaceutical | GMP compliance, HEPA/ULPA compatibility, stainless steel design | ISO 14644, GMP |
| Semiconductor | ESD-safe, minimal particle emission, high IP class | ISO 14644-1 |
| Food Processing | Easy-to-clean design, high chemical resistance, corrosion-proof | ISO 14644-5 |
Practice: Installation, Operation, and Maintenance
Proper handling throughout the life cycle—installation, daily operation, and maintenance—ensures that cleanroom PCs maintain compliance and reliability. The following best practices are industry-proven:
Installation and Integration
- Install PCs in locations minimizing obstruction of airflow, especially near HEPA filter outlets or return vents.
- Ensure all cable entries are professionally sealed and avoid exposed wiring.
- Prefer wall mounts or stainless steel stands to limit floor contact and dust accumulation.
- Use touch-based solutions over keyboards and mice; if necessary, select models rated for cleanroom use.
Operation and Daily Use
- Use covers or shields during intensive cleaning in adjacent areas.
- Operate with gloves and other personal protective equipment (PPE) as standard in the respective cleanroom class.
- Log access and system use for traceability and process validation in GMP environments.
Cleaning and Disinfection
- Follow a defined cleaning protocol compatible with the PC design and surface material.
- Use only approved cleaning agents (alcohol-based or others as specified).
- Regularly check and replace seals and gaskets to ensure continued IP protection.
- Perform scheduled audits and particle monitoring around device placement to verify ongoing compliance.
Maintenance and Longevity
- Periodic inspection and servicing of all seals, touch panels, and connectors.
- Update firmware to address security vulnerabilities and maintain compliance with industry standards.
- Maintain thorough documentation of maintenance and upgrades for regulatory traceability.
FAQ: Frequently Asked Questions about Industrial PCs in Cleanrooms
- What distinguishes a cleanroom PC from a standard industrial PC? Cleanroom PCs are specifically developed with sealed, hygienic stainless steel housings, fanless operation, high IP protection, and ESD-compliant design. These features prevent contamination, endure intensive cleaning, and conform to rigorous cleanroom standards such as ISO 14644 and GMP.
- Why is stainless steel the preferred material? Stainless steel is resistant to corrosion, chemicals, and mechanical impact. Its non-porous surface allows for thorough cleaning and disinfection, meeting the elevated hygiene requirements of cleanrooms.
- How is particle emission minimized in cleanroom PCs? Through fanless construction, sealed mechanical design, careful selection of low-outgas materials, and smooth surface finishing, particle generation is kept to a minimum.
- What role does ESD compliance play in cleanroom environments? ESD protection prevents the buildup and accidental discharge of static electricity, which could damage sensitive electronics and attract dust or particles.
- How often should cleanroom PCs be cleaned and maintained? Cleaning intervals depend on cleanroom class, usage frequency, and industry practices. Daily external wiping and periodic deep cleaning—with checks and documentation—are common, especially in pharmaceutical and food processing environments.
- Can standard PCs be upgraded for cleanroom use? Generally, no. Retrofitting usually cannot guarantee the required sealing, material resistance, and hygienic surface qualities prescribed by ISO 14644 and GMP for cleanroom settings.
Future Trends: Digitalization and Automation in Cleanrooms
The evolution of cleanroom environments is driven by digital transformation with an increasing role for automation, IoT solutions, and real-time data analytics. Advanced industrial PCs are becoming pivotal nodes in smart cleanrooms, enabling the integration of:
- Automated Monitoring: Real-time environmental sensors for continuous particle monitoring, temperature, and humidity control.
- Predictive Maintenance: AI-powered diagnostics reduce downtime by predicting failures and maintenance needs in advance.
- Seamless Integration: Industrial PCs interface with MES (Manufacturing Execution Systems), ERP, and quality management systems for process optimization.
- Wireless and Touchless Interfaces: Minimize direct contact and lower contamination risks while improving operator efficiency.
- Data Security and Validation: Secure, validated systems for audit trails, compliance, and traceability under GMP/ISO guidelines.
Looking ahead, the suitability of cleanroom industrial PC solutions will increasingly depend on their adaptability to digital workflows, ability to support higher cleanroom classes, and ease of remote maintenance. These trends promise safer, more reliable, and more productive cleanroom operations across all relevant industries.
Selecting the right industrial PC for cleanroom applications is more than a matter of technical compatibility—it is about ensuring long-term operational stability and process safety. At PSB GmbH, we draw on our extensive expertise in developing systems that withstand the rigors of daily use, rigorous cleaning routines, and strict environmental requirements. Our manufacturer-neutral philosophy means we always focus on the best solution for each customer, from bespoke hardware design through to scalable production and dependable delivery. Every system undergoes comprehensive burn-in testing, reflecting our commitment to reliability and longevity. As demands for hygienic, high-performance IT solutions continue to evolve, PSB GmbH remains dedicated to delivering future-oriented, customer-specific systems that set new standards in cleanroom computing.
