Product Overview

SERAJEL is a premium hydroxyapatite-based injectable semi-finished product designed for medical device manufacturers. It serves as a high-quality intermediate material for the development of bone graft substitutes and soft tissue fillers. Engineered to meet stringent regulatory and quality standards, SERAJEL provides a reliable foundation for innovative medical applications.

Key Features

ASTM F1185 Grade Hydroxyapatite Powder – Ensuring superior biocompatibility.
Optimized for Hard and Soft Tissue Applications – Suitable for bone grafts and dermal fillers.
Customizable Formulation – Designed for flexibility in medical device development.
Non-Sterile Supply – Allows for sterilization in final product packaging.
ISO 13485 Certified Manufacturing – Ensuring traceability and compliance with international standards.

Applications

SERAJEL is specifically developed for use in sterile medical device production, including:

Bone Graft Substitutes – Injectable biomaterials for orthopedic and dental applications.
Soft Tissue Augmentation Fillers – Enhancing tissue regeneration and repair.
Injectable Biomaterials – Facilitating advanced medical innovations.

Packaging & Delivery

50 mL Syringes – Ready for further processing.
Outer Packaging: Tyvek pouch for additional protection.

Sterilization

Recommended Method: Steam sterilization at 121°C for 20 minutes.
Note: Other sterilization methods may affect material properties.

Storage Conditions

Temperature: Store between 5°C – 30°C.
Humidity: Maintain low humidity conditions.
Precautions: Avoid exposure to high temperatures and direct sunlight.

Biological Compliance (ISO 10993)

SERAJEL has undergone rigorous biocompatibility testing, including:

Cytotoxicity, Genotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Implantation, Degradation

Note: These results apply to the sterile product only. The final medical device manufacturer is responsible for additional biological testing.

Contact Us

For pricing and further information, please contact Meridian Biomaterials Co.
Email: [email protected]

We are happy to assist with any questions regarding specifications, applications, and customization options.