Production process: sustainability, innovation and quality Made in Italy

Inspired by the biological changes in plant genetics, Phitogen Holding has devised cyclical maintenance protocols based on soft treatments to safeguard natural beauty.

To manufacture medical devices based on Hyaluronic Acid, the company uses raw materials of excellent quality and an ecosustainable production process, with high technological innovation and completely Made in Italy.

Latest generation facilities

Latest generation facilities

At its 8,000 square metre manufacturing site based in San Benedetto del Tronto in the Marche region of Italy, Phitogen Holding SPA makes use of the most advanced manufacturing systems and techniques in the field of aesthetic and orthopaedic medicine.

The production cycle of Hyaluronic Acid-based medical devices, both intradermal and intra-articular, takes place in clean rooms under the supervision of highly qualified personnel.

From the selection and extraction of raw materials to packaging and storage, Phitogen medical devices are manufactured according to strict production protocols, in compliance with ISO 9001, ISO 13485 and ISO 14001 quality management system procedures.

The way of beauty by Phitogen

The Phitogen manufacturing process consists of eight different stages that make up the “path to beauty”. Each is performed in strict compliance with national and international regulations, applying the highest safety standards.

1

1.

Raw materials

Ultra-pure hyaluronic acid, which at this stage is still in powder state, is placed in special containers where it is weighed, sealed and taken to the sterile liquid filling department where the more viscous hyaluronic acid solution is prepared.

2

2.

Cross-Linking

In this first stage, ultra-pure Hyaluronic Acid with no nucleic acids and no residual proteins is mixed with the cross-linking agent BDDE at low temperature over a long period of time. This unique manufacturing process, known as cross-linking, preserves the specific visco-elastic properties of Hyaluronic Acid, and above all allows smaller quantities of the chemical cross-linking agent BDDE to be used, resulting in a superior quality product with a very high degree of biocompatibility.

3

3.

Purification

The mixture is purified using a dialysis process via WFI (water for injection). This process eliminates any residual BDDE molecules, ensuring a product with a high level of purity and low toxicity.

4

4.

Mixing

The product is mixed with a buffered solution to provide a neutral pH value.

5

5.

Filling

The resulting mixture is placed in the tank of a filling machine with lack of oxygen, where it will remain for several hours while waiting for the lab tests to prove that it meets the quality and purity requirements. Once checked, the product is ready to be filled using an automatic filling machine.

6

6.

Sterilisation

The pre-filled syringes are then autoclaved, using moist heat for 15 minutes at 121 degrees Celsius. Once the sterilisation process is complete, the syringes are left on stand-by while waiting for the results of the quality control tests.

7

7.

Quality control and product release

At this stage, final tests are carried out to certify that the quality and safety requirements for the release of the finished product have been met: – Extrudability and pH control – External tests at certified laboratories – Sterility and LAL test – and Visual inspection.

8

8.

Packaging

At this stage, the syringe is placed in a thermoformed blister pack sealed with medical paper and inserted into the packaging. Finally, the product is packed and transferred to the warehouse where it will be stored at storage temperatures while awaiting dispatch to the customer.

1

1.

Raw materials

Ultra-pure hyaluronic acid, which at this stage is still in powder state, is placed in special containers where it is weighed, sealed and taken to the sterile liquid filling department where the more viscous hyaluronic acid solution is prepared.

2

2.

Cross-Linking

In this first stage, ultra-pure Hyaluronic Acid with no nucleic acids and no residual proteins is mixed with the cross-linking agent BDDE at low temperature over a long period of time. This unique manufacturing process, known as cross-linking, preserves the specific visco-elastic properties of Hyaluronic Acid, and above all allows smaller quantities of the chemical cross-linking agent BDDE to be used, resulting in a superior quality product with a very high degree of biocompatibility.

3

3.

Purification

The mixture is purified using a dialysis process via WFI (water for injection). This process eliminates any residual BDDE molecules, ensuring a product with a high level of purity and low toxicity.

4

4.

Mixing

The product is mixed with a buffered solution to provide a neutral pH value.

5

5.

Filling

The resulting mixture is placed in the tank of a filling machine with lack of oxygen, where it will remain for several hours while waiting for the lab tests to prove that it meets the quality and purity requirements. Once checked, the product is ready to be filled using an automatic filling machine.

6

6.

Sterilisation

The pre-filled syringes are then autoclaved, using moist heat for 15 minutes at 121 degrees Celsius. Once the sterilisation process is complete, the syringes are left on stand-by while waiting for the results of the quality control tests.

7

7.

Quality control and product release

At this stage, final tests are carried out to certify that the quality and safety requirements for the release of the finished product have been met: – Extrudability and pH control – External tests at certified laboratories – Sterility and LAL test – and Visual inspection.

8

8.

Packaging

At this stage, the syringe is placed in a thermoformed blister pack sealed with medical paper and inserted into the packaging. Finally, the product is packed and transferred to the warehouse where it will be stored at storage temperatures while awaiting dispatch to the customer.

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Phitogen Holding S.p.A.

The parent company of a group of companies that for over twenty years have focused on providing contract manufacturing and distribution of medical devices based on hyaluronic acid used in aesthetic medicine and dermocosmetics.

Contacts

Via Valtellina, 21
San Benedetto del Tronto (AP)
63074 - Italy

Tel: +39 0735 762020
Email: export@phitogenspa.it