Biomaterial Packaging & Kitting

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

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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

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

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?

Material Inspection & Preparation: Ensuring biomaterials meet required specifications for sterility and performance.
Custom Packaging Design: Developing tailored packaging configurations, including sterile pouches, trays, and barrier systems.
Sterilization Process: Utilizing ethylene oxide (EtO), gamma irradiation, or steam sterilization methods based on material compatibility.
Kitting & Final Assembly: Organizing biomaterials into surgical-ready kits for ease of use in clinical settings.
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.