+1 201-898-0502
info@sterelynx.com
4002 Southwest Fwy, Houston, Texas 77027, USA
“RTU, Engineered for Confidence”
RTU PACKAGING
Sterelynx
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
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.
2R 2ml: 100 pcs
6R/10R 6ml/10ml: 48 pcs
20R 20ml: 24 pcs
Nest and Tub
Premium Nest and Tub
Assembly
Packaging Method
RTU VIALS
| Vial Size | Pc/Nest | Nest/CT | Total Pcs/CT | Dimension (mm) | GW (Kg) |
|---|---|---|---|---|---|
| 2R/2 ml | 100 | 15 | 1500 | 780×245×535 | 15.7 |
| 2R/2 ml | 228 | 10 | 2280 | 780×245×280 | 15.2 |
| 6R/6 ml | 48 | 15 | 720 | 780×245×535 | 14.6 |
| 6R/6 ml | 96 | 8 | 768 | 780×245×280 | 10.4 |
| 10R/10 ml | 48 | 15 | 720 | 780×245×535 | 15.6 |
| 10R/10 ml | 96 | 8 | 768 | 780×245×280 | 11.6 |
| 20R/20 ml | 24 | 15 | 360 | 780×245×535 | 15.0 |
| 20R/20 ml | 60 | 8 | 480 | 780×245×280 | 12.6 |
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.
