Skip to main content

Cleanroom Manufacturing

At HARBEC, we manufacture precision parts with tight tolerances in a decentralized ISO Class 8 cleanroom for flexible production. We also specialize in additive manufacturing and 3D printing, CNC machining, injection molding, mold making, and quality assurance for the medical market.

What is a Class 8 Cleanroom?

A Class 8 cleanroom is a controlled environment that meets specific cleanliness standards defined by the International Organization for Standardization (ISO). Cleanrooms are designed to minimize the presence of airborne particles, such as dust, microbes, aerosol particles, and chemical vapors, to a level suitable for the specific processes or activities conducted within them.

In the ISO classification system, cleanrooms are graded based on the maximum allowable number of particles per cubic meter of air within a specified particle size range. Class 8 cleanrooms adhere to the ISO 14644-1 standard, which specifies the following particle limits:

  • Maximum allowable particles ≥0.5 micrometers: 3,520 particles per cubic meter
  • Maximum allowable particles ≥5 micrometers: 29 particles per cubic meter

Key Characteristics and Features of a Class 8 Cleanroom:

  • Air Quality Control: Class 8 cleanrooms are designed to maintain a high level of air quality by utilizing sophisticated air filtration systems to minimize the presence of contaminants.
  • Positive Pressure: Typically, a Class 8 cleanroom is maintained at a positive pressure relative to adjacent spaces, ensuring that air flows from the cleanroom to less clean areas, preventing the entry of contaminants.
  • Controlled Airflow: The airflow within the cleanroom is carefully controlled to maintain uniform distribution and prevent the accumulation of particles.
  • Stringent Cleaning Procedures: Regular and thorough cleaning and maintenance protocols are followed to ensure cleanliness and compliance with the specified standards.
  • Personnel Garments and Procedures: Individuals entering a Class 8 cleanroom are required to wear appropriate cleanroom garments, such as gowns, gloves, masks, and shoe covers, to prevent contamination.
  • Monitoring and Testing: Continuous monitoring and testing of air quality, particle counts, temperature, humidity, and other parameters are performed to ensure compliance with the ISO standards.

Class 8 cleanrooms are commonly used in industries such as electronics, pharmaceuticals, biotechnology, medical devices, and aerospace, where precise control of air quality is critical to manufacturing processes, research, and development.

The Decentralized Cleanroom Module

Decentralized systems are preferred for their effectiveness and cost-efficiency over centralized ones. In centralized cleanrooms, maintenance halts all processes since the injection molding machine operates within the same space. Conversely, a decentralized approach situates production equipment like injection molding machines outside the cleanroom, allowing uninterrupted operations focused on processing, handling, inspection, and secondary procedures. Maintenance of the mold can occur without disrupting these crucial functions. HARBEC's decentralized cleanrooms feature HEPA units, encapsulated conveyors, and pass-throughs, enhancing cleanliness control and reducing operating costs. This setup allows easy reconfiguration using standard cleanroom openings for part conveyance. However, hybrid cleanrooms, though initially cost-effective, can be less efficient and challenging to adapt.
  • FED 100,000 Availability: FED 100,000 classification adheres to specific cleanliness standards, ensuring a controlled environment.
  • Laminar Flow Clean Room: Incorporates a laminar flow setup to maintain optimal air quality and minimize particulate contamination.
  • Daily Particle Monitoring: Regular monitoring of particle levels to guarantee a clean and controlled production environment.
  • Optimized for Production: Designed and structured to enhance production efficiency and precision.
  • Secondary Labeling/Packaging: Facilities for secondary labeling and packaging to meet stringent quality and compliance requirements.
  • Size and Dimensions: Spans an area of 32×50 feet, covering 1,600 square feet, providing ample space for streamlined operations.
  • Contamination Control: Implementation of measures to control and prevent contamination, ensuring product quality and consistency.
  • Regulatory Compliance: Adherence to industry-specific regulations, meeting the necessary compliance standards.
  • Focus on Product Quality and Consistency: Prioritizing product quality and consistency through a controlled production environment.
  • Improved Product Longevity: A controlled setting contributing to the longevity and durability of the produced products, meeting high-quality standards.

Benefits of Decentralizing Cleanroom Manufacturing

Decentralized cleanrooms have been popular in Europe for years. HARBEC recognizes many of the advantages, including the following:

Reduce Contamination Concerns

Having the machine outside the clean room removes unnecessary particulates and heat within the clean room in turn requiring less energy for operation. In addition, maintenance and operations of molding machines are conducted outside the clean room further reducing contamination risks and concerns.

Handle Processes on Multiple Lines

Decentralized cleanroom manufacturing can reduce downtime. If one line fails, it does not necessarily affect the others. Furthermore, having multiple lines means faster turn times and lower labor costs. If your job requires a larger or smaller molding machine, we simply swap it out with an existing machine or add it to our clean room without creating downtime for other products in production.

Enhance Energy Efficiency

An essential energy efficiency concept for cleanroom systems or components is to achieve the most productive work for the least amount of energy (lowest energy cost). In general, decentralized cleanrooms use less energy than centralized ones.

Elevating Standards, Every Day

HARBEC’s commitment to continuous improvement means you’re always getting the latest in technological advancements for a competitive advantage in your industry.