CAPABILITY
Sterilization Management
Alentra coordinates sterilization for medical, pharmaceutical, drug delivery, diagnostic, life science, and consumer products, from method selection through validation. With access to steam, ethylene oxide (EtO), gamma, e-beam, and chlorine dioxide gas sterilization, we help products arrive sterile and ready for use without adding another supplier to manage.
CAPABILITY
Sterilization Management
Alentra coordinates sterilization for medical, pharmaceutical, drug delivery, diagnostic, life science, and consumer products, from method selection through validation. With access to steam, ethylene oxide (EtO), gamma, e-beam, and chlorine dioxide gas sterilization, we help products arrive sterile and ready for use without adding another supplier to manage.
Where Products Are Protected
Sterile, without the
extra step.
Sterilization is often the last step before a product reaches the market, and one of the most critical. We coordinate the full process with qualified sterilization providers, from choosing the right method for your materials to managing validation, so molding, assembly, packaging, and sterilization stay connected through one partner.
Full range of methods
Steam, EtO, gamma, e-beam, and chlorine dioxide gas sterilization.
Validation managed
Sterilization validation process management from start to finish.
One point of contact
Sterilization coordinated alongside molding, assembly, and packaging.
INSIDE STERILIZATION MANAGEMENT
Five capabilities,
one standard.
The right method for every material, with validation guiding every program.
Validation Process Management
We manage the sterilization validation process, helping confirm that each method consistently achieves sterility without compromising product performance.
Ethylene Oxide (EtO)
Low-temperature gas sterilization, typically between 30°C and 60°C, suited for heat-sensitive plastics and devices.
Gamma & E-Beam
Radiation-based sterilization. Gamma uses Cobalt-60, and e-beam uses an electron beam.
Steam Sterilization
High-temperature sterilization from 121°C to 134°C for heat-tolerant materials.
Chlorine Dioxide Gas
Low-temperature gas sterilization as an alternative for heat- and radiation-sensitive products.
Sterilization is just one part of a connected program.
Our Process
From finished package to sterile product.
1
Select
Match the method to your materials.
2
Package
Sterile-ready packaging configurations.
3
Coordinate
Managed with sterilization providers.
4
Validate
Validation process management.
5
Deliver
Sterile and ready for use.
WHY Alentra
A sterilization partner that simplifies your supply chain.
Single-source
One partner, start to sterile
Molding, assembly, packaging, and sterilization management with one partner reduces handoffs and simplifies your supply chain.
Full range
The right method for every product
Access to steam, EtO, gamma, e-beam, and chlorine dioxide gas sterilization helps match each product to a compatible method.
Quality-first
Validated and documented
Sterilization validation process management, backed by ISO 13485:2016-certified quality systems.
QUALITY & COMPLIANCE
Quality systems built for sterile delivery.
Our ISO 13485 quality management system, FDA registration, and validation services provide documented support for every sterilization program.
- ISO 13485:2016 quality management system
The core medical-device quality standard, applied across our operations.
- FDA registered
Supporting production for medical, pharmaceutical, and diagnostic applications.
- Sterilization validation management
Validation process management confirms each sterilization method performs consistently. - Inspection & traceability
Visual inspection, labeling and serialization support, and weekly reporting on corrective actions.
Ready to simplify sterilization?
Whether you're choosing a method for a new product or moving an existing program, our team is ready to coordinate sterilization and validation for what's next.
Locations
Coordinated from our facilities to yours.
From Alentra's manufacturing and packaging operations, products are prepared in sterile-ready packaging and coordinated through sterilization, then stored in our coast-to-coast warehouses with safety stocking options and shipping lane management to keep them moving to market.
5
Sterilization methods available
5
Coast-to-coast warehouses
Class 7 & 8
ISO cleanroom packaging
ISO 13485
Certified quality system
WHAT COMES NEXT
Connected capabilities.
Packaging & Kitting
Custom packaging configurations, custom and clinical trial kitting, labeling, and RFID management.
Assembly & Automation
Custom manual and automated assembly, ultrasonic welding, and bonding that turn molded components into finished devices.
Cleanroom Manufacturing
Molding, assembly, and kitting in ISO Class 7 and 8 cleanroom environments.
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 products that need to arrive sterile and ready to use. Alentra connects molding, assembly, packaging, and sterilization management through one accountable team.