A device that’s been engineered, molded, machined, and assembled with precision still depends on one more thing to reach a surgeon the way it left the building: sterility, seal integrity, and traceability that hold up through packaging, kitting, and delivery. That’s where packaging and kitting come in — a controlled process that carries a device through sealing, testing, kitting, and sterilization coordination without losing any of the quality already engineered into it.
Class 7 & Class 8 Cleanroom Packaging: Where Protection Starts
Packaging medical devices within certified Class 7 and Class 8 cleanrooms keeps contamination risk controlled from the moment a device enters packaging. Documented procedures carry that control through every step — consistent processing, lot control, and product identification — so quality and regulatory requirements are supported by the process itself, not verified after the fact.
Pre-Validated Packaging Options: A Faster Path to Market
Choosing from established packaging configurations — Tyvek® and nylon pouches, trays, and other options matched to device and performance requirements — lets a program lean on packaging already supported by sealing, integrity, aging, transit, and distribution validation. That reduces both development time and validation risk, giving OEMs a more efficient path from packaging design to program startup.
Pouch & Tray Sealing: Built for Dependable Sterile Barriers
A sterile barrier system is only as reliable as the seal that forms it. Controlled sealing parameters support consistent seals and long-term package integrity across a wide range of device sizes, geometries, materials, and presentation requirements, while documented processes and in-process controls carry that same seal quality across every production run — not just the first one.
READY TO MOVE YOUR DEVICE FROM PACKAGING TO PATIENT?
Talk to Red Star’s packaging team about cleanroom packaging, pre-validated configurations, kitting, and sterilization coordination — all under one roof.
Medical Device Kitting: Complete, Procedure-Ready Configurations
Kitting brings components, instruments, and packaging together into the complete configuration a procedure actually calls for. Consolidating component manufacturing, assembly, packaging, and kitting with one manufacturing partner keeps kit contents, quantities, labeling, and lot information under a single set of documented procedures, so what ships is a correctly configured, procedure-ready kit prepared for sterilization and distribution.
Package Testing & Validation Support: Confidence Through the Full Shelf Life
In-house testing evaluates seal strength and package performance using controlled methods, and an on-site accelerated aging chamber supports the package validation and shelf-life studies a program needs before launch. Together, they help confirm a package will protect a device not just on the day it ships, but through validated transit, distribution, and the full length of its shelf life.
Red Star’s Managed Sterilization: One Point of Contact From Packaging to Delivery
Red Star coordinates sterilization through qualified providers — managing scheduling, documentation, and logistics so an OEM has one point of contact from packaging through sterilized product delivery. Organized records and clear communication keep a product’s progress through sterilization and release visible throughout, supporting the timelines and supply continuity a program depends on.
- Class 7 and Class 8 cleanroom packaging with documented processes for consistent processing, lot control, and traceability
- Pre-validated packaging configurations — Tyvek® and nylon pouches, trays, and more — to accelerate implementation and reduce validation risk
- Validated pouch and tray sealing for dependable sterile barrier systems across a wide range of devices
- Complete, procedure-ready kitting with controlled contents, labeling, and lot traceability
- In-house package testing and an on-site accelerated aging chamber to support shelf-life and distribution validation
- Red Star-managed sterilization coordination, with one point of contact from packaging through sterilized delivery
Cleanroom packaging, sealing, kitting, testing, and sterilization coordination are usually spread across several specialty vendors, each with its own systems and its own schedule to align. Red Star brings all of it together under one roof and one quality system, so a device that’s already been engineered, molded, machined, and assembled with precision carries that same level of control all the way through packaging, kitting, and sterilized delivery — from cleanroom to customer.
