Cleanroom Assembly and Manufacturing: Creating a Custom Assembly Process


The client: A client in the assisted reproductive space came to Natech with a device that needed to be injection molded and assembled.

The product: The device was designed to separate the best-performing sperm to increase fertilization rates and improve motility. The client required a partner to design and validate a repeatable and scalable assembly process to create a finished device that could be manufactured in a cleanroom environment to avoid particulate contamination.


The client presented a prototype device that was being manually assembled using laser cut plastics. This assembly method involved bonding plastic parts together and clamping them together overnight for 12 hours to ensure the adhesive was bonded together.

However, this was an insufficient method that took a long time, resulting in a slow and inefficient production process. It was not scalable and was causing issues with quality control. The client needed a partner who could help to design a more efficient process for mass production.


Custom Assembly Process

To overcome these challenges, our team created and validated a repeatable, scalable custom assembly process using both customized and standard, off-the-shelf equipment. 

First, we constructed an ISO Class 8 clean room for the client, to guarantee a specific level of cleanliness in accordance with international standards.

natech plastics cleanroom

The assembly process involved optimizing the product for scalability, which involved replacing laser cutting with injection molding and manual alignment with fixturing and molded-in features. This process combined multiple components into one, resulting in significant time savings per piece.

In the assembly process, a highly-trained cleanroom technician ensures precise placement of the membrane and adhesive layers by using tweezers to hold the membrane and place it on top of the first adhesive layer.

Medical Assembly Device ISO Class 8 Cleanroom medical assembly

They ensure the alignment and absence of bubbles before applying another piece of adhesive to complete the laminated structure. This attention to detail and dexterity-required process results in a high-quality final product. The use of a trained person minimizes defects, improves efficiency, and guarantees a consistent end product.

Then, to eliminate operator bias and output inconsistencies, we built six custom laminators. This automated the process and ensured it was controlled and repeatable. This machine is used to apply pressure and remove any air bubbles from the laminated materials. The machine ensures a uniform and even distribution of pressure, resulting in a smooth and consistent laminate.

The vacuum lamination step is only 8 seconds long. This step not only saves time, but it also improves the quality and consistency of the assembly process. This process helped ensure a proper bond between layers and reduced the risk of production line stoppage and supply chain risks.

To package the device, the team also replaced the original Tyvek pouch with a Tyvek sealed thermoformed tray for packaging the device. 

Medical Device Assembly Cleanroom Packaging


This custom assembly process increased throughput by reducing the time and effort required to manually remove air bubbles and wrinkles, allowing for faster and more consistent production. This resulted in increased productivity, reduced waste, and lower costs. Taking the assembly process from 12 hours to 8 seconds was a significant improvement for the client.

By automating the process, it reduced the risk of human error and inconsistencies that can occur when manual methods are used. This reduces the risk of inconsistency as each piece undergoes the same process, regardless of who performs it or when. This results in a more consistent and reliable production process, which can increase throughput, reduce the risk of production line stoppage, and reduce supply chain risks. 

With the custom assembly process, we transformed the client’s original prototype device from a manual and non-scalable product to a fully optimized and scalable manufacturing process.

blister packaging

The process of creating the custom assembly for the client’s device took two years of design, process design, troubleshooting, and risk management. The entire team was dedicated to updating the process and ensuring it was validated to meet international standards. Since inconsistent output was a risk based on who was performing the task, the lamination process was crucial in making the assembly process repeatable.

Overall, the custom assembly process and automated laminating helped to ensure the consistency and reliability of the final product, reducing supply chain risks and improving the efficiency of the production line. Natech is the FDA-registered manufacturer for this device and maintains the highest standard of quality and process controls. Natech was able to create a custom assembly process for the client’s device that was repeatable, scalable, and assembled in a cleanroom environment.