Product Overview

RHEOFIRM is a comprehensive range of bulk semi-finished injectable dermal filler intermediates, specifically designed for product development. It is a crosslinked hyaluronic acid formulation, containing 23 mg/mL of active ingredient, suitable for various intradermal filler indications once manufactured and certified under the applied regulations by the developer. RHEOFIRM is available in three distinct formulations, each tailored to meet diverse application needs:

RHEOFIRM F: Minimal crosslinking, minimal particle size
RHEOFIRM M: Medium crosslinking, medium particle size
RHEOFIRM V: Maximal crosslinking, maximal particle size

These formulations are available with or without Lidocaine HCl (0.3% w/w), to accommodate a wide range of requirements. The product is designed for fine, mid, and deep applications, respectively.

All RHEOFIRM batches exhibit an osmolality value of 330 ± 50 mOsm/Kg and contain residual crosslinker BDDE at levels below 2 ppm.

Please note that the final medical device manufacturer is responsible for conducting additional biological testing.

Key Features

Injection-Grade Hyaluronic Acid: Ensuring the highest quality and consistency in the final product.
Customizable Formulation: Offering flexibility to suit specific development needs.
Non-Sterile Supply: Delivered in non-sterile form, allowing for sterilization during the final product packaging process.
ISO 13485 Certified Manufacturing: Ensuring traceability and compliance with international standards for medical devices.

Applications

RHEOFIRM is specifically developed for use in the production of sterile medical devices.

Packaging & Delivery

1.000 mL Containers or 50 mL Syringes: Ready for further processing.
Outer Packaging: Each container is securely packed in a Tyvek pouch for additional protection.

Sterilization

Recommended Method: Steam sterilization at 121°C for 20 minutes.
Note: Alternative sterilization methods may impact the 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.

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.