OUR STATE-OF-THE ART MANUFACTURING UNIT COMPLIES WITH THE
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
their lifespan in the skin, TEOSYALŪ gels are cross-linked.
This involves linking macromolecules of hyaluronic acid
together by means
which make them more resistant to being broken
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.
In order to
remove any BDDE residue which may not have reacted during
cross-linking, the gel is purified.
is then packaged in 1ml glass syringes. (This stage is fully
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
syringe is individually inspected by specially trained
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
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
bacterial endotoxin test, pH values, etc,). The Quality
independently of the Production department, analyses the
results of these tests and authorizes the release of compliant
Total control of these processes enables us to
provide products which are both safe and long-lasting.