Protecting Your Device from Cleanroom to Customer.

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Class 7 & Class 8 Cleanroom Packaging

Red Star provides controlled cleanroom packaging designed to protect product integrity and meet quality and regulatory requirements.

Controlled Packaging Environment
Package medical devices within certified Class 7 and Class 8 cleanrooms.
Protect Product Integrity
Controlled processes help minimize contamination risk throughout packaging and handling.
Maintain Quality and Traceability
Documented procedures provide consistent processing, lot control, and product identification.

Pre-Validated Packaging Options

Our pre-validated packaging solutions can reduce validation requirements, accelerate implementation, and provide a more efficient path to market.

Accelerate Packaging Implementation
Leverage established medical device sterile packaging configurations to reduce development time and streamline program startup.
Reduce Validation Risk
Utilize packaging options supported by established sealing, integrity, aging, transit, and distribution validation.
Select the Right Packaging Solution
Choose from Tyvek® and nylon pouches, trays, and other configurations based on device type and performance requirements.

Pouch & Tray Sealing

Red Star provides validated sealing processes that create dependable sterile barrier systems for a wide range of medical devices and procedure kits.

Reliable Seal Performance
Controlled sealing parameters support consistent seals and long-term package integrity.
Flexible Packaging Configurations
Accommodate various device sizes, geometries, materials, and presentation requirements.
Consistent Production Quality
Documented processes and in-process controls ensure repeatability across every production run.

Medical Device Kitting

Our kitting services bring components, instruments, and packaging together into complete configurations prepared for sterilization and distribution.

Simplify Your Supply Chain
Consolidate component manufacturing, assembly, packaging, and kitting with one trusted medical device manufacturing partner.
Maintain Kit Accuracy and Traceability
Control kit contents, quantities, labeling, and lot information through documented procedures.
Deliver Complete, Procedure-Ready Kits
Receive correctly configured kits prepared for sterilization and final distribution.

Package Testing & Validation Support

Our in-house testing capabilities help confirm the integrity of medical device sterile packaging and support confidence throughout your product’s shelf life and distribution cycle.

Verify Package Integrity
Evaluate seal strength and package performance using controlled testing methods.
Support Shelf-Life Requirements
Utilize our on-site accelerated aging chamber to support package validation and shelf-life studies.
Prepare for Distribution
Support validated transit and distribution requirements to help ensure devices remain protected through delivery.

Red Star-Managed Sterilization

Red Star coordinates sterilization through qualified providers, giving you one trusted point of contact from medical device sterile packaging through product delivery.

Simplify Sterilization Coordination
Reduce administrative demands through Red Star-managed scheduling, documentation, and logistics.
Maintain Process Visibility
Track products through sterilization and release with organized records and clear communication.
Support Reliable Product Delivery
Coordinate packaging, sterilization, and final delivery to help protect timelines and supply continuity.

Benefits of Working with Red Star

Sterile Packaging Expertise

With 25+ years of manufacturing experience, we deliver medical device sterile packaging solutions designed to protect your devices and maintain product integrity.

Integrated Packaging Solutions

From material selection and design through production, our integrated capabilities provide reliable, efficient packaging solutions tailored to your needs.

Validated for Confidence

Our comprehensive testing and validation processes help ensure the highest level of packaging quality, sterility, and performance throughout the product lifecycle.

Sterile Packaging & Kitting FAQ

Our team can work with you to find the right packaging type and configuration for your medical device. We offer multiple packaging solutions as well as custom tray and kit design options proven to lower costs and improve manufacturing efficiency.

We offer sterile packaging and kitting for a multitude of applications, including custom procedure trays, multicomponent single-use instrument kits, surgical hardware sets, drug delivery systems, and direct patient care kits.

Red Star is ISO 13485 certified and uses Class 7 & 8 cleanrooms for all sterile packaging. Each package is clearly labeled to meet the FDA’s UDI requirements and validated to comply with package integrity and sterility maintenance.

Our packaging process includes inspection and validation steps that check finished products against your exact specifications, whether you’re manufacturing single parts, producing individual devices, or designing multipart kits.

At our 40,000 square foot facility, we handle every step of the manufacturing process, from product development through assembly and packaging. By bringing these capabilities together under one roof, we can accelerate your manufacturing program for fast time to market and high-volume production support.