PCR Development and Manufacturing
Enplas specializes in the development and manufacture of the custom plastic devices, consumables, and components used in high-quality, high-performance PCR devices. From intricate microfluidic chips to entire cartridges and housings, we provide highly specialized engineering support, product development, manufacturing, and assembly services at globally recognized quality standards.
Enplas has decades of experience developing and mass-producing PCR products for both large, industrial-scale laboratories and point-of-care testing (POCT) devices. Our expertise allows for a fast path to product launch and ensures a reliable supply of high-performing PCR devices at a commercial scale. Our products have served market-leading customers with great success.
From Intricate Microfluidic Chips to Entire PCR Cartridges
Enplas is your one-stop solution for PCR device manufacturing needs. We meet complex requirements such as injection molding a million microfluidic chips with only a ±1μm channel depth tolerance, engineering and overmolding cartridges with leak-tight fluid seals, onboarding lyophilized reagents, automated assembly of complete cartridges, and more.
Our microfluidics manufacturing solutions include material combinations, lamination with PCR compatible films, and bio-compatible assembly methods that withstand PCR requirements. Enplas also provides scalable device assembly of gaskets, nozzles, and other components such as tubes and pouches with automation.
Development Capability
We offer thorough DFM to maximize customer product performance, mid-to-low volume prototyping, and product performance evaluation. We have extensive experience with on-chip PCR and provide engineering feedback based on our knowledge of high-performance PCR requirements. Enplas prioritizes every customer’s unique validation requirements and strives to understand them on an intimate level.
Manufacturing Services
Enplas offers comprehensive manufacturing services to support our customers throughout the entire product life cycle. Customers can rely on Enplas’s expertise in manufacturing critically functional devices such as cartridges, nanoscale microfluidics, elastomer fluid sealing, and more for a steady supply of quality PCR products. Proficient engineering and product performance testing ensure that our injection molding and assembly processes always produce a high yield of good quality products for the required volume. We’re committed to providing high-quality manufacturing solutions that meet our customers’ unique needs and help bring their PCR products to market faster and more efficiently.
Quality Control and Mass Production
Enplas ensures quality control through ISO 13485 certification and our established quality assurance system, which includes thorough DFM, FMEA, process validation, scientific molding, performance testing and 100% automated inspections (depending on needs). Enplas supplies commercial large volumes of medical and diagnostic products with consistently high quality for reliable PCR performance.
Human-Focused Engineering Support
Enplas provides highly specialized engineering support for PCR cartridges, microfluidics, fluid sealing, and more. Our human-focused engineering support offers communication and partnership that you may miss elsewhere. We work closely with our customers to fully understand their needs and provide tailored solutions. Whether you need assistance with design optimization, material selection, or manufacturability analysis, our team of experienced engineers is here to help. We take pride in our ability to work collaboratively with our customers to achieve their goals and ensure the success of their projects.
Speed and Flexibility
Enplas offers speed and agility in developing and manufacturing PCR products. We understand that customers may be under tight schedules for FDA approval or that product demand may spike in a short period. Enplas engineers stay flexible and proactive to meet your timelines and product needs.
Enplas’s design-for-manufacturing (DFM) approach includes prototyping while keeping mass production in mind. By incorporating mass production considerations from the start, Enplas prevents prototype designs from being unsuccessful in transitioning to a scalable mass production process. This early-stage engineering also speeds up production ramp up and keeps the process cost efficient.
Customers receive engineering consultation and faster problem solving appropriate for PCR applications due to Enplas’s expertise in PCR devices.
Speak with an Enplas engineer to discuss solutions for your next project.