CAPABILITY
Cleanroom Manufacturing
From molding to assembly and kitting, we manufacture medical, diagnostics, and pharmaceutical products in ISO Class 7 and 8 cleanrooms. Seven facilities on the East and West Coasts, backed by ISO 13485 certification, give you the capacity to scale with confidence.
CAPABILITY
Cleanroom Manufacturing
From molding to assembly and kitting, we manufacture medical and pharmaceutical products in ISO Class 7 and 8 cleanrooms. Seven facilities on the East and West Coasts, backed by ISO 13485 certification, give you the capacity to scale with confidence.
WHERE QUALITY IS PROTECTED
Controlled environments. Consistent results.
Alentra brings injection molding, blow molding, assembly, and kitting into ISO Class 7 and 8 cleanroom environments, all managed by one accountable team. With every process controlled and documented under one quality system, contamination risk stays low, traceability stays intact, and your products move from launch to scale-up with confidence.
Coast-to-coast cleanroom capacity
Seven cleanroom facilities on the East and West Coasts, with open capacity to support your program as it grows.
Contamination control at every step
Molding, assembly, and kitting happen in controlled environments that protect product integrity from start to finish.
Regulated-industry rigor
ISO 13485-certified, FDA-registered operations with strict process controls and full traceability.
Inside Our Cleanrooms
Five controlled processes, one standard.
Sensitive components and assemblies are produced in ISO Class 7 and 8 cleanrooms, with contamination control guiding every step from molding to kitting.
Controlled Environment Processing
Our ISO 13485:2016-certified cleanrooms provide the controlled conditions needed to produce sensitive medical and pharmaceutical components. Strict process control and product traceability minimize contamination risk and protect product integrity at every stage.
Cleanroom Injection Molding
Precision molding in controlled environments for drug delivery, diagnostic, and medical device components.
Cleanroom Blow Molding
Blow-molded components produced to the cleanliness standards required for pharmaceutical packaging and laboratory products.
Cleanroom Assembly
Components are assembled in controlled conditions to reduce contamination risk and maintain product integrity.
Cleanroom Kitting
Cleanroom kitting brings components together into complete, protected packages ready for use.
Cleanroom manufacturing is just one part of a connected program.
Our Process
Controlled from first shot to final kit.
1
Cleanroom Molding
Injection and blow molding.
2
Contamination Control
Particle control at every stage.
3
Cleanroom Assembly
Assemble in controlled conditions.
4
Traceability
Documented throughout production.
5
Cleanroom Kitting
Grouped, packaged, and protected.
WHY Alentra
A cleanroom partner built for regulated markets.
Scalable capacity
Cleanroom space on both coasts
Seven cleanroom facilities on the East and West Coasts offer open capacity, including 35,000 sq ft in Auburn, NY, with an ISO Class 7 cleanroom inside a Class 8 environment.
Quality-first
Certified and controlled
ISO 13485:2016-certified, FDA-registered operations maintain strict process control and product traceability throughout production.
Healthcare-focused
Built for sensitive products
We apply the most stringent standards of safety, quality, and precision to components for drug delivery, diagnostics, laboratory, and pharmaceutical packaging applications.
QUALITY & COMPLIANCE
Quality systems built for controlled production.
In cleanroom manufacturing, control has to be proven, not assumed. Our ISO 13485 quality management system, FDA registration, validation services, and inspection capabilities provide documented support for every cleanroom program.
- ISO 13485:2016 quality management system
Applied across our ISO Class 7 and 8 certified cleanrooms.
- FDA registered
Supporting production for medical, pharmaceutical, and diagnostic applications.
- IQ / OQ / PQ validation services
Process validation and capability studies confirm cleanroom processes run consistently.
- Inspection & contamination control
Full-dimensional and on-floor inspection, particle control, and weekly reporting on results and corrective actions.
Ready to scale in a controlled environment?
Whether you're launching a new program or expanding an existing one, our cleanroom capacity and quality systems are ready to support what's next.
Locations
Cleanroom capacity,
coast to coast.
With ISO-certified cleanrooms across the East and West Coasts, Alentra gives medical, pharmaceutical, and diagnostic programs access to controlled domestic capacity. Our cleanroom network supports molding, assembly, and kitting under an ISO 13485:2016 quality system, with open capacity to help programs scale.
7
ISO-certified cleanrooms
45,000+
Sq ft of cleanroom space
Class 7 & 8
ISO cleanroom environments
4
Cleanroom locations
WHAT COMES NEXT
Connected capabilities.
Plastic Molding
Injection, blow, insert, over, two-shot, and micro molding with tight-tolerance, repeatable process controls.
Automation & Assembly
Manual and automated assembly that turns molded components into finished devices.
Packaging & Kitting
Custom and clinical trial kits assembled in the cleanroom, so components arrive clean and ready for the next stage of production.
Advanced Technologies & Innovation
RFID integration, sterilization services, rapid prototyping, and micro molding for parts as small as 0.001 grams.
Ready to move your program forward?
Bring us a new product, an existing program, or a project that needs more cleanroom capacity. Alentra connects cleanroom molding, assembly, kitting, and quality systems through one accountable team.