Healthcare instruments often contain extremely sensitive optical components and, without suitable equipment and strict process controls in place, particulate contamination can occur during production, leading to manufacturing defects and costly rework. Our 4,000 square foot optical assembly room, constructed specially to control contamination, allows no more than 1,000 particles larger than 0.5 microns to be present per cubic foot of air. The facility contains a full suite of scalable optical-alignment workstations featuring our innovative vPoke® technology, a zero-defect, computer-directed process that offers significant improvements in assembly, testing and alignment efficiencies, as well as increased quality control and traceability. Several practices and protocols must be followed in order for the optical assembly room to effectively maintain the level of cleanliness required to build optical systems, including:
- Controlled access: only authorized personnel are allowed to enter, and they must follow proper gowning procedures to prevent the introduction of particles.
- Positive air pressure: the optical assembly room is maintained at a positive air pressure relative to the surrounding environment to prevent the ingress of particles.
- HEPA filtration: high efficiency particulate air filters are used to capture particulates from the air before it is circulated back into the room.
- Controlled environment: the temperature and humidity levels are controlled to minimize the generation of particles.
- Minimal surface contamination: all surfaces are cleaned regularly to avoid contamination.
By following these protocols, the optical assembly room serves as a controlled environment for optical system builds, minimizing the risk of particulate contamination and ensuring the reliability and quality of the finished product.
Planning for Success
Our dedicated team of certified optical engineers and technicians will work closely with you prior to manufacturing to compile a mutually agreed upon project charter. This outlines all optical handling, assembly and inspection procedures in detail, and provides a set of templates and checklists covering every aspect of process validation, system build qualification, and design output and verification. Such rigorous testing protocols are essential to verify that a finished product meets the required performance specifications.
End-to-End Quality Assurance
It’s important when you’re choosing your contract manufacturer to look for a partner who has the necessary infrastructure and process controls to support your specific project needs, as well as a proven track record in the medical device and life sciences markets. Paramit is a reliable and trusted OEM partner that specializes in the manufacture of instrumentation that requires top-grade optical assembly builds and integration. Our complete end-to-end optical service – including new product introduction, design for manufacturing, failure analysis and real-time manufacturing insights – covers the entire product realization life cycle to ensure a quality product and a faster time to market.