The Best of

Hyaluronic Acid

OUR STATE-OF-THE ART MANUFACTURING UNIT COMPLIES WITH THE STRICTEST STANDARDS.

The manufacturing facility was designed and built in compliance with the recommendations of the EMEA (European Medicines Agency) and the FDA (Food and Drug Admi­nistration). This unit has specially designed clean rooms with state-of-the-art equipment. The manufacturing process is carried out and validated in compliance with international ISO 9001 and ISO 13485 standards and European Council Directive 93/42 concerning medical devices.

Formulation and Cross Linking;

To optimize their lifespan in the skin, TEOSYALŪ gels are cross-linked. This involves linking macromolecules of hyaluronic acid together by means of "bridges" which make them more resistant to being broken down, particularly by hydroxyl radicals. The cross-linking agent used in TEOSYALŪ is BDDE. After cross-linking, the hyaluronic acid molecules form a dense, interlocking mesh.

Purifying;

In order to remove any BDDE residue which may not have reacted during cross-linking, the gel is purified.

Primary Packaging;

The gel is then packaged in 1ml glass syringes. (This stage is fully automated)

Sterilization;

Because hyaluronic acid is sensitive to heat, traditional sterilization cycles would damage the gel, which would cause the gel to becomes less viscous and less effective. It is for this reason our Laboratories have developed a dedicated sterilization cycle for TEOSYALŪ gels that result in the products retaining their optimal visco-elastic properties.

Final Inspection;

Each syringe is individually inspected by specially trained operators.

Secondary Packaging;

The syringes are then labeled and blister packaged. Instructions for use and traceability labels are then added and slipped into a cardboard package. All these processes are fully automated.

Testing;

A large number of tests are carried out on each batch of TEOSYALŪ product range in compliance with EU standards EN 1174-1 and EN 1174-2 and with the European Pharmacopeia in force (sterility test, bacterial endotoxin test, pH values, etc,). The Quality department, acting independently of the Production department, analyses the results of these tests and authorizes the release of compliant batches.

Total control of these processes enables us to provide products which are both safe and long-lasting.

General:

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