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> Life Science Outsourcing specializes in biomaterial packaging and kitting solutions, ensuring sterility, integrity, and regulatory compliance for implantable biomaterials.

Source: https://lso-inc.com/biomaterial-packaging/

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# Biomaterial Packaging & Kitting

[Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form)

![Biomaterial Packaging & Kitting](https://lso-inc.com/api/media/file/biomaterial_003-3.jpg)

FDA-Registered

Manufacturing Facility

ISO 13485

Certified Quality System

12 Cleanrooms

Class 5–8

125,000+ Sq Ft

Regulated Manufacturing

3 Facilities

CA | NH | Costa Rica

ISO 17025

Accredited Packaging Lab

## Sterile, Compliant, and Ready-to-Use Packagingas Part of Our End-to-End Solutions

LSO ensures biomaterials are securely packaged, sterilized, and kitted for seamless surgical and clinical use. As part of our end-to-end solutions, we provide validated packaging and kitting that maintains sterility, enhances efficiency, and meets strict FDA and ISO standards.

## What is Biomaterial Packaging & Kitting?

Biomaterial packaging and kitting involve **secure containment, sterilization, and organized packaging** of synthetic and natural biomaterials for surgical and clinical use.

-   **Sterile packaging**: Custom solutions for maintaining biomaterial integrity.
-   **Kitting for surgical procedures**: Ready-to-use kits for streamlined workflows.
-   **Regulatory validation**: Compliance with FDA and ISO standards for medical implants.

## Who Needs Biomaterial Packaging & Kitting?

-   **Medical device OEMs** requiring validated sterile packaging.
-   **Hospitals and surgical centers** for pre-configured implant kits.
-   **Biotech and research organizations** needing customized biomaterial packaging.

## How Does Biomaterial Packaging & Kitting Work?

1.  **Material Inspection & Preparation**: Ensuring biomaterials meet required specifications for sterility and performance.
2.  **Custom Packaging Design**: Developing tailored packaging configurations, including sterile pouches, trays, and barrier systems.
3.  **Sterilization Process**: Utilizing ethylene oxide (EtO), gamma irradiation, or steam sterilization methods based on material compatibility.
4.  **Kitting & Final Assembly**: Organizing biomaterials into surgical-ready kits for ease of use in clinical settings.
5.  **Regulatory Documentation & Validation**: Providing full traceability, validation reports, and compliance documentation for regulatory approval.

## What standards apply?

-   **ISO 13485** – Medical device packaging quality management.
-   **FDA 21 CFR Part 820** – U.S. FDA Quality Management System Regulation (QMSR).
-   **ISO 11607** – Packaging validation for terminally sterilized medical devices.

## Why LSO?

-   **Expertise in biomaterial packaging** with customized solutions.
-   **Validated sterilization methods** ensuring product safety and compliance.
-   **Comprehensive kitting solutions** improving surgical efficiency and handling.

## Full EtO Validation

Comprehensive packages for regulatory compliance.

## Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

## Robust Qualification

Secure with 2X qualification.

## Choice of PCDs

Tailored to your sterilization needs.

## Ready to get started?

Talk to a specialist about biomaterial packaging & kitting.

[Get a Validation Plan Reviewed](https://lso-inc.com/solutions/packaging-validation/#intake-form) [Explore Solutions](https://lso-inc.com/#solutions)