Certified quality

Phitogen Holding SPA manufactures medical devices on behalf of third parties in strict compliance with industry regulations and through the application of nationally and internationally validated production protocols.

In particular, all the Hyaluronic Acid medical devices are designed and developed by Phitogen in application of specific procedures established in the ISO 9001, ISO 13485 and ISO 14001 quality management systems.

State-of-the-art Clean Rooms

State-of-the-art Clean Rooms

The production of high quality certified medical devices takes place in an innovative 5,000 sqm manufacturing plant located in San Benedetto del Tronto in the Marche region of Italy since 2015. The plant makes use of state-of-the-art and eco-sustainable processes for the development of high-end Hyaluronic Acid products completely Made in Italy.

The entire production process takes place in state-of-the-art clean rooms, featuring a controlled atmosphere where specialised personnel constantly monitor temperature, pressure, humidity, particle count and microbiological contamination of the products, operating according to the certification standards to guarantee highest quality and safety.

Quality control and product release

Quality control and compliance with safety regulations are the keywords that mark the define the entire Phitogen production process.

Before the last stage – packaging and storage pending shipment to the customer – the product is tested by accredited external laboratories to verify and certify that it meets the quality and safety requirements necessary for the release of the finished product.

Among the various tests carried out are pH and extrudability, which is an indicator of crosslink quality and is measured with a dynamometer used as a stator.

Finally, the devices are checked by visual inspection, meaning by inspecting each batch to detect any imperfections or contaminants within the injectables

PHITOGEN PRODUCTION

Are you looking for support to develop hyaluronic acid-based products?

Phitogen Holding Spa

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