+1 201-898-0502
info@sterelyxinc.com
212 South 13th Avenue, Laurel, MS 39440
“RTU, Engineered for Confidence”
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.
Primary packaging for medicinal products ensuring safety and reliability.
Strictly controlled manufacturing under global Good Manufacturing Practices.
Full regulatory documentation and DMF support for US FDA submissions.
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%.
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%.
Small-molecule and parenteral drug products
Proteins, peptides, and complex formulations
Liquid and lyophilized vaccine applications
Oncology, orphan drugs, and critical care
Development, stability, and compatibility studies
Ready-to-fill sterile hospital applications
Vials are 100% inspected in an ISO 7-class clean room to ensure zero defects before processing.
Neutral borosilicate tubular glass vials are 100% inspected and washed with WFI (Water for Injection) to remove all particles.
Vials are depyrogenated in a tunnel drying cabinet according to the Pharmacopeia requirements to ensure they are endotoxin-free.
Vials are placed into the nest tray and tub by automatic manipulators in a high-standard ISO 4.8-class clean room.
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.
Terminal sterilization is performed via ETO (Ethylene Oxide) according to ISO 11135 standards to ensure complete sterility.
Sterelyx 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.
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
