Our Cleanroom Manufacturing Process

Cleanroom manufacturing is crucial in producing high-quality, contamination-free plastic injection moulded components for industries such as medical devices, aerospace, and automotive, where precision and cleanliness are paramount.

At Nordell, we adhere to ISO 7 standards to ensure the utmost cleanliness and precision.

This blog will detail our cleanroom manufacturing process, from staff entry protocols to equipment and product handling.

Maintaining ISO 7 Standards in Our Cleanroom

Ensuring our cleanroom meets ISO 7 standards is paramount to our operations.

The ISO 7 classification requires maintaining a controlled environment with a maximum of 352,000 particles per cubic meter, each measuring 0.5 micrometres or larger.

To achieve this, we implement stringent measures across our cleanroom processes.

Staff Entry Protocols

Before stepping into our ISO 7 cleanroom, our staff diligently follow a meticulous entry procedure, leaving no room for contamination risks.

The process includes:

1. Pre-entry Training: All personnel undergo comprehensive training on cleanroom protocols, including hygiene, gowning procedures, and contamination control.
2. Gowning Process: Staff must wear specialised cleanroom garments, including coveralls, gloves, masks, and shoe covers. These garments are designed to prevent particles from clothing and skin from entering the cleanroom environment.
3. Hand Sanitation: Staff must sanitise their hands using alcohol-based solutions to ensure no contaminants are brought into the cleanroom.
4. Controlled Entry: Access to the cleanroom is controlled and monitored, ensuring only authorised personnel enter. Strict log records are maintained.

Handling Equipment and Products

In cleanroom manufacturing, maintaining the integrity of equipment and products is vital.

Our procedures include:

1. Equipment Preparation: Equipment entering the cleanroom is thoroughly cleaned before entry, and any raw materials are decanted into plastic totes before entry. Only plastic pallets and tote bins for final packing are allowed into a cleanroom, with cardboard boxes and wooden pallets NOT allowed.
2. Controlled Environment: The cleanroom is equipped with HEPA filters, which are designed to trap particles as small as 0.3 microns, and positive air pressure systems. These systems continuously filter and circulate clean air, ensuring a contamination-free environment.
3. Product Handling: Operators wear plastic gloves to eliminate the risk of introducing contaminants in clean, controlled conditions. Each manufacturing process step is designed to minimise human contact and reduce contamination risks, ensuring the integrity and quality of our products.
4. Regular Monitoring: We conduct regular particle count and microbial monitoring to ensure the cleanroom environment consistently meets ISO 7 standards.

Comprehensive Cleanroom Manufacturing Services

Our cleanroom manufacturing process at Nordell ensures the highest quality and precision for your plastic injection moulded components.

From stringent staff entry protocols to meticulous equipment and product handling, we maintain ISO 7 standards to deliver superior results.

For more information about our cleanroom manufacturing capabilities, visit our Cleanroom Injection Moulding page.

To understand our commitment to ISO 7 standards, please see our ISO 7 Cleanroom Standards page.

Adhering to these rigorous protocols ensures that every product manufactured in our cleanroom meets the highest cleanliness and quality standards, making Nordell a trusted partner in cleanroom manufacturing.