CAPABILITY
Assembly & Automation
Alentra's assembly capabilities transform individual components into fully integrated products and subassemblies ready for the next stage of the supply chain. For medical, pharmaceutical, drug delivery, diagnostic, life science, and consumer products, we deliver manual and automated assembly, ultrasonic welding, bonding, and pad printing, from product launch through high-volume commercial manufacturing.
CAPABILITY
Assembly & Automation
Alentra's assembly capabilities transform individual components into fully integrated products and subassemblies ready for the next stage of the supply chain. For medical, pharmaceutical, drug delivery, diagnostic, life science, and consumer products, we deliver manual and automated assembly, ultrasonic welding, bonding, and pad printing, from product launch through high-volume commercial manufacturing.
WHERE PARTS COME TOGETHER
Repeatability, built in.
From simple assemblies to complex, multi-component products, we develop efficient, repeatable processes tailored to each product's unique requirements. Validated processes and built-in quality controls support consistent performance, traceability, and regulatory compliance from early production through commercial-scale manufacturing.
Manual to automated
Trained technicians and customized automation systems, matched to each product's complexity and volume.
Controlled environments
Assembly in ISO Class 7 and 8 cleanrooms when product cleanliness requires it.
Regulated-industry rigor
Validated processes and traceability built to medical device regulatory standards.
INSIDE ASSEMBLY & AUTOMATION
Five capabilities,
one standard.
From simple assemblies to complex, multi-component products, with process control guiding every build.
Automated Assembly
Customized automation systems improve throughput, reduce variability, and keep product quality consistent at high volumes. Working with engineering, manufacturing, and trusted automation partners, we design part handling, inspection systems, and integrated production cells with pellet-to-pallet expertise.
Manual Assembly
Trained technicians follow documented procedures for products with complex assembly requirements and specialized handling needs, including bonding, inspection, and finishing.
Ultrasonic Welding
Plunge and continuous rotary welding fuse plastic parts, including parts made of different materials, into a single piece with a tight seal and no adhesives or fasteners.
Bonding Assembly
Specialty adhesives, including UV-activated bonding agents, and pneumatic presses join two or more molded parts.
Device, Component & Sub-Assembly
Precision mechanical assembly of disposables, reusables, and implants, including catheter-based, flexible endoscopy, electro-mechanical, and minimally invasive surgical devices.
Assembly is just one part of a connected program.
Our Process
From validated process to finished assembly.
1
Develop
Assembly process and test method development.
2
Validate
Design verification and process validation.
3
Automate
Automated handling and inspection systems.
4
Assemble
Manual or automated, at any scale.
5
Trace
Traceability through every step.
WHY Alentra
An assembly partner
built to scale.
Scalable capacity
Built for volume
Manual and automated assembly built for medium- to high-volume production, with the flexibility to support new programs from launch through full commercial scale.
Quality-first
Validated and traceable
Validated processes, documented procedures, and built-in quality controls keep every assembly consistent, traceable, and aligned with medical device regulatory standards.
Single-source
Molding, assembly, and packaging together
One partner for molding, assembly, labeling, and kitting simplifies supply chains. Reagent buffer bottle assemblies, for example, combine injection and blow molding, assembly, RFID, labeling, and kitting.
QUALITY & COMPLIANCE
Quality systems built for controlled assembly.
Our ISO 13485 quality management system, FDA registration, validation services, and inspection capabilities provide documented support for every assembly program.
- ISO 13485:2016 quality management system
The core medical-device quality standard, applied across our assembly operations. - FDA registered
Supporting production for medical, pharmaceutical, and diagnostic applications.
- IQ / OQ / PQ validation services
Process validation and documented procedures confirm assembly processes run consistently. - Traceability & inspection
Traceability throughout the manufacturing workflow, inline and visual inspection, and weekly reporting on corrective actions.
Ready to scale your assembly program?
Whether you need manual assembly for complex, specialized products or automation for high-volume production, our assembly capabilities and quality systems are ready to support what's next.
Locations
Assembly capacity,
coast to coast.
With assembly operations and warehousing on the East and West Coasts, Alentra supports medium- to high-volume programs, with safety stocking options and shipping lane management to keep finished assemblies moving.
Class 7 & 8
ISO cleanroom assembly
Pellet-to-pallet
Automation expertise
5
Coast-to-coast warehouses
ISO 13485
Certified quality system
WHAT COMES NEXT
Connected Capabilities
Cleanroom Manufacturing
Molding, assembly, and kitting in ISO Class 7 and 8 cleanroom environments.
Advanced Technologies & Innovation
RFID integration, sterilization services, rapid prototyping, and micro molding for complex, next-generation products.
Packaging & Kitting
Custom and clinical trial kitting, labeling, serialization, and sterilization management, with cleanroom packaging when required.
Logistics
Warehousing, safety stocking options, and shipping lane management keep finished products moving to market.
Ready to move your program forward?
Bring us a new device, an existing program, or an assembly that's ready to automate. Alentra connects molding, assembly, packaging, and quality systems through one accountable team.