+1 201-898-0502
info@sterelynx.com
4002 Southwest Fwy, Houston, Texas 77027, USA
“RTU, Engineered for Confidence”
Advanced Ready To Use Sterile Packaging & Drug Delivery Systems
Designed to meet the needs of both emerging biotech innovators and established pharmaceutical organizations, our solutions enable accelerated scale-up while minimizing operational complexity and regulatory risk.
ISO 15378 Certified
Primary packaging for medicinal products ensuring safety and reliability.
GMP-Compliant Facilities
Strictly controlled manufacturing under global Good Manufacturing Practices.
DMF & FDA Readiness
Full regulatory documentation and DMF support for US FDA submissions.
Ready To Use Sterile Packaging Systems
Your Globally Trusted Partner in Ready To Use Sterile Packaging Systems
Fully automated production takes place in a GMP-certified cleanroom (Class C + Class A). With 100% visual and AI inspection, micron-level precision ensures complete sealing safety for highly sensitive drugs throughout the entire process.
Sterile packaging delivers a more attractive appearance, superior mechanical performance, and fewer processing steps - reducing downtime and failure risks.
Through rigorous sterilization and particle control, the product supports "Ready-to-Fill" operations right out of the box. This eliminates the need for costly equipment investments such as washing machines, water systems, and tunnel ovens - saving floor space and maintenance costs. It helps manufacturers reduce capital expenditure, minimize factory footprint, and cut overall costs by up to 80%.
Quality & Compliance Alignment with RTU System Components
Where Sterility Meets Certainty
Through rigorous sterilization and particle control, our products support "Ready-to-Fill" operations right out of the box. This eliminates the need for costly equipment like washing machines and tunnel ovens, helping manufacturers reduce capital expenditure and cut overall costs by up to 80%.
Quality And Compliance Alignment
- US FDA aseptic processing expectations
- EU GMP Annex 1 principles
- Container Closure Integrity (CCI) requirements
- Extractables & Leachables study compatibility
Each RTU configuration is supplied with:
- Sterilization validation support
- Batch traceability documentation
- Regulatory documentation for DMF support
Applications
Applications Across Critical Drug Delivery Segments
Injectable Pharmaceuticals
Small-molecule and parenteral drug products
Biologics & Biosimilars
Proteins, peptides, and complex formulations
Vaccines
Liquid and lyophilized vaccine applications
Specialty & High-Value Drugs
Oncology, orphan drugs, and critical care
Clinical Trial & R&D
Development, stability, and compatibility studies
Institutional Use
Ready-to-fill sterile hospital applications
Aseptic Process
Our RTU Packaging Aseptic Process
Type 1 Borosilicate Glass Vial
Vials are 100% inspected in an ISO 7-class clean room to ensure zero defects before processing.
Few Vials Inverted Being Washed With Water
Neutral borosilicate tubular glass vials are 100% inspected and washed with WFI (Water for Injection) to remove all particles.
Depyrogenation
Vials are depyrogenated in a tunnel drying cabinet according to the Pharmacopeia requirements to ensure they are endotoxin-free.
Tray & Tub Loading
Vials are placed into the nest tray and tub by automatic manipulators in a high-standard ISO 4.8-class clean room.
Tyvek Sealing & Sterile Bag Bagging
One Tyvek paper is put on the vial top and the tub is sealed. Then, the tub is placed into a Tyvek bag in an ISO 7-class clean room.
Final Sterilization
Terminal sterilization is performed via ETO (Ethylene Oxide) according to ISO 11135 standards to ensure complete sterility.
Why Choose RTU Packaging
Sterelynx Ready-to-Use (RTU) vials and cartridges are developed to meet the highest global pharmaceutical packaging standards.
Type I borosilicate glass offering superior chemical resistance and mechanical strength.
Pre-washed, depyrogenated, and terminally sterilized—ready for direct aseptic filling.
Validated nest-and-tub system prevents glass-to-glass contact, reducing breakage.
Manufactured in controlled cleanroom environments for particle-free handling.
Fully compliant with ISO, USP, and GMP standards for global pharma markets.
Designed for seamless compatibility with automated aseptic filling lines.
Available in multiple sizes and formats for injectables and biologics.
Why Choose Sterelynx?
Faster Clinical and Commercial Scale-Up
Lower Operational Risk
Reduced Capital Expenditure On Washing/Sterilization Lines
Strong Fit For Emerging Biotech and CDMO Workflows
Customized RTU Configurations
Dedicated After-Sales Technical Support
Flexible Supply and Delivery Models
Reliable Long-Term Partnership
“Experience Sterelynx Quality, Sterility & Consistency”
