Ursatec One Source: finished products including aseptic fillingPreservative-free for a healthy life®Pure cosmetics for healthy beauty®

Safety & Quality

Safety – without preservatives

Safety – without preservatives: The 3K® and COMFORT® dosage systems developed by Ursatec Verpackung GmbH guarantee that the product solution remains microbiologically clean even after opening the packaging system.

The 3K® and COMFORT® dosage systems developed by Ursatec Verpackung GmbH guarantee that the product solution remains microbiologically clean even after opening the packaging system.

Both systems are characterized by the exclusive principle of dual protection: Microbiologically hermetic valves combined with oligodynamic features.

Microbiological safety systems

The product outlet and the subsequent flow of air are the major source of potential contamination in any applicator. This is where the nose and the nasal mucosa come into contact with the nozzle. Conventional atomizers make an ideal portal through which microorganisms can freely penetrate right into the product. The intake of ambient air to equalize the pressure in the container after administering a dose is another source of bacterial contamination. 

Preservatives are therefore essential and unavoidable in conventional applicators in order to guarantee the approved purity and shelf life of the product solution.

Dual microbiological protection

Dual microbiological protection: The safety of the patented preservative-free Ursatec dosage systems is based on a unique combination of two independent protection mechanisms.

The safety of the patented preservative-free Ursatec dosage systems is based on a unique combination of two independent protection mechanisms.

Protective surface areas (1) reduce the number of germs near the product outlet and in the product channel. The microbiologically tightly closing outlet valve (2) protects the system from contamination.

State-of-the-art production sites

Ursatec products are exclusively manufactured and processed by qualified and certified partners, with whom a longstanding and trustful cooperation is the aim. The construction of individual components as well as the assembly of the components to the full functional system is carried out according to established quality criteria, in accordance with the principles of GMP-rules of the WHO. For the reproducible maintenance of the defined high quality standard, all necessary technical, organizational and structural measures have been taken and are verified by regular audits. All facilities, production lines and testing installations are routinely cleaned, serviced and tested on their proper performance. All steps of manufacture and control relevant for quality assurance are carried out according to written operating procedures and are documented correspondingly.

Sterilization

All Ursatec Verpackung GmbH preservative-free systems are sterilized using proven, reliable and validated processes.

For more information see page Service.

Sterile filling

Ursatec Verpackung GmbH offers aseptic filling of sterile solutions for nasal, buccal, sublingual, otological and topical applications.

For more information see page Service.

Approved Quality Management

Ursatec Verpackung GmbH is certified according to DIN EN ISO 9001 and DIN EN ISO 13485.

Downloads:

URSATEC_DIN_EN_ISO_9001_(2008)
URSATEC_DIN_EN_ISO_13485_(2012)

The tests for the release control of pumps and bottles of the preservative-free Ursatec systems are carried out according to established internal operating procedures and testing instructions on basis of data obtained by numerous in-process controls. All results are documented in the testing certificates, and a batch found in compliance with specifications is released.

As a result of the requirements with respect to the microbiological purity of the container content, the pump and the container must form a tightly sealed system. The microbiological safety of Ursatec’s systems is therefore routinely controlled. Customers formulations can have an impact on the test parameters – therefore all relevant parameters, e.g. interaction product/container, efficiency of germ-reducing measures, preciseness of dosing, etc., must be additionally tested with the finished product, i.e. the sealed container filled with the respective formulation. These tests and further experiments, such as stability tests, in-use safety tests, in-use stability tests, etc. can be carried out at Ursatec’s or at cooperating institutions.