Cleanroom Injection Molding

Cleanrooms are critical to the injection molding process. Learn what a cleanroom is, how it’s used, why the standards of a cleanroom are essential, and how Spectrum Plastics Group Minneapolis’s cleanroom supports the success of our projects.

What is a cleanroom environment?

A cleanroom is a controlled environment where technicians use equipment and gear to minimize and eliminate pollutants such as dust, microbes, and other airborne particles.

Cleanrooms are used in manufacturing to varying degrees based on many factors, such as:

  • The end-product being produced in the application,
  • The specific part and its placement in the application workflow,
  • The potential risks or contamination.

With our vast experience, Spectrum can manage the complexity of different cleanroom applications.

Why is a cleanroom important for industries like medical devices?

Many medical devices come into contact with or are inserted into the human body. Therefore, manufacturers must utilize the highest standards of precision and cleanliness when producing medical device products to ensure the safety of patients.

Additionally, standards significantly drive the cleanroom technology and processes needed in medical device manufacturing. Most medical device manufacturing must be conducted in a cleanroom between Class 100,000 (ISO 8) and Class 100 (ISO 5).

Here are some of the key reasons why cleanroom molding is important:

  • Precision and Consistency: Cleanroom molding facilities are equipped with advanced machinery and technologies that allow for precise control over the molding process and the molding environment. This results in consistent and high-quality output, which is particularly important for industries where even minor variations can lead to product defects or failures.
  • Reduced Contamination Risk: Cleanroom environments are designed to minimize the presence of particles, dust, and other contaminants that can negatively impact the quality and functionality of the molded products. This is crucial in industries like medical devices and pharmaceuticals where even small particles can cause serious issues.
  • Compliance with Regulatory Standards: Industries like healthcare and pharmaceuticals are subject to stringent regulatory requirements. Cleanroom molding helps companies meet these standards by ensuring that products are manufactured in environments that meet specific cleanliness and contamination control guidelines.
  • Increased Product Reliability: In healthcare, reliability is of paramount importance. Cleanroom molding helps ensure that components and products are manufactured in a controlled environment, minimizing the risk of defects or failures due to contaminants. Cleanroom molding is particularly critical in the medical and healthcare industries where products like surgical instruments, implantable devices, and pharmaceutical packaging must meet extremely high standards of cleanliness to ensure patient safety and compliance with regulatory requirements.
  • Protecting Sensitive Materials: Some materials used in molding processes can be sensitive to environmental conditions. Cleanroom environments help protect these materials from exposure to contaminants, ensuring the integrity of the final product.
  • Enhanced Customer Confidence: When customers in industries that require cleanroom molding (such as healthcare) know that a product has been manufactured in a controlled, clean environment, it instills confidence in the quality and reliability of the product.

Cleanroom Classifications and Standards:

Cleanrooms are classified into different levels, depending on the “allowable” amount of particles (contaminants) in the space. This is conveyed as the number of particles per cubic meter.

Medical injection molding is typically conducted in an ISO Class 8 cleanroom. An ISO 8 cleanroom provides air quality levels with an allowable maximum of 100,000 particles (≥0.5 um) per cubic foot of interior air with a minimum of 20 air exchanges per hour.

What is the cleanroom like at the Spectrum Minneapolis facility?

The cleanroom facility in Minneapolis is an ISO Class 8 room with 10,000 square feet of controlled environment.

Spectrum designed the cleanroom to manage the unique challenges of cleanroom molding and workflow. Real-time data capture, process quality monitoring, and in-cavity pressure monitoring are components of this cleanroom’s ultra-modern digital technology framework.

Other features in our cleanroom include:

  • Class 8 cleanroom, capable of Class 7.
  • 18 vertical and horizontal presses, ranging in size from 14 – 166 tons.
  • 3 bays in one room for injection molding and assembly.
  • Higher ceilings than traditional labs due to automated equipment and cells.
  • Electric presses reduce contaminants and provide risk mitigation.
  • Future expansion is available to meet market demand.

Our cleanroom facilities are ideal for testing, developing, and assembling highly sensitive parts and products. These parts are made from materials engineered to deliver very specific physical and chemical characteristics.

Work Area and Personal Attire

The work area and personnel within the Minneapolis cleanroom conform to environmental control standards through the use of: 

  • Gowning: We understand that gowning involves a human element, which is the most significant risk in a cleanroom. Our gowning area was built with plenty of space for personnel to come in and out. We meet all the appropriate cleanroom standards.
  • Interlocked Doors: Both doors to the cleanroom are interlocked, preventing contaminants from outside.
  • Hand Washing Stations: Our state-of-the-art hand washing stations rotate and dry.
  • Monitored Pressure & Humidity: We monitor pressure and humidity tied to a centralized computer system.
  • Training: Personnel are rigorously trained and adhere to all cleanroom standards.
  • Cleaning and Maintenance: Workers must keep their equipment and work area organized and always sanitized. All parts are cleaned according to a predetermined process.

Quality and Safety

Keeping the cleanroom environment free from contaminants requires precise control of the area's airflow, temperature, and humidity and strict cleaning procedures for the people, equipment, and materials that pass in and out of the cleanroom.

Other advantages of our cleanroom include:

  • Low bioburden.
  • Heightened awareness of cleanliness and quality. 
  • Minimize microbes and foreign particles.
  • Manages fluid path.

We fully understand the specifications of each part and the standard of excellence our customers require.

External and Internal Audits

We subject our cleanroom to regular external and internal audits to ensure quality control.

Our external audits have always confirmed our high-quality standards. An external certified professional verifies our airflow, filter flow, and bioburdens. We are ISO 14644 certified, and our cleanrooms are suited for manufacturing various types of medical devices.

Experienced members of our team perform our internal audits.

How are markets evolving and requiring more cleanliness?

Cleanroom molding is vital for industries where precision, cleanliness, and contamination control are paramount. It helps companies meet regulatory standards, produce high-quality, reliable products, and maintain the integrity of sensitive materials. This specialized manufacturing process plays a crucial role in ensuring the safety, functionality, and quality of products in various high-stakes industries.

Customers’ expectations for even higher quality cleanliness increase with the production of medical molding products.

At Spectrum, we have anticipated continued growth of key markets and can expand our cleanrooms as demand changes.

Not all parts require cleanroom injection molding. We also offer injection molding services for lower-risk applications that require a controlled environment but no certification.

Do you have any questions about our cleanroom and injection molding services? Contact us for more information.

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