The tests for the release of pumps and bottles of our systems for preservative-free formulations are carried out according to defined manufacturing and test instructions on the basis of data generated by numerous in-process controls.
All results are documented in test certificates. Only a batch that meets the specifications is released.
Due to the requirements for microbiological purity of the container contents, the pump and container must form a tightly sealed system. The microbiological safety of our systems is therefore routinely checked. Since different formulations can affect the test parameters, all relevant parameters such as interactions between container contents and bottle, sterility, accuracy of dosing, etc. must also be tested with the finished product. These tests, as well as other tests such as stability and safety tests during application, are carried out by us at cooperating institutions.
Our patented 3K® and COMFORT®-systems offer maximum protection against microbiological contamination, even after the product has been opened. Both systems are characterized by the unique URSATEC principle: Microbiologically tight-closing valves in combination with oligodynamically acting components.
All our systems are sterilized on the basis of long-standing, validated processes.
- Sterile filling:
We offer filling of sterile solutions for the application in the nose, mouth, throat, ear and skin.
- Quality management:
We are certified according to DIN EN ISO 15378, ISO 9001 and ISO 13485.
The registration requirements of the product must be taken into account right from the start of formulation development.
The same is true when revising a formulation for a new registration. The documents required by the authorities for registration include:
- Composition and formulation development
- Manufacturing controls
- Quality control of raw materials
- Stability testing of the finished product
All individual steps of the manufacturing process are continuously monitored by adequate in-process controls, in the course of which all quality-relevant parameters, such as appearance, purity, dimensions and function, are checked at specified intervals for compliance with the specified acceptance criteria. For features of URSATEC pumps relevant to function and safety, an automated 100% check (e. g. valve tightness, functionality, flow, etc. by means of compressed air testing) is carried out during assembly. The uniformity of the manufactured product quality is ensured by suitable sampling plans with representative retention samples. The suitability of the manufacturing process has been proven by retrospective validation on numerous production batches over more than 20 years now.
The tests for the final inspection of the pumps and cylinders of the URSATEC systems are carried out according to internally defined instructions and test specifications. For the final release, the data of the in-process inspections are also taken into account. In addition to a generally scheduled visual inspection (appearance, absence of particles, no impurities, etc.), the standard inspection also includes the dimensions as well as aspects relevant to function and safety. In the case of URSATEC pumps, further parameters such as priming, average mass and uniformity of the dispensed dose, etc. are tested batch by batch with reference solution according to pharmacopoeia criteria or comparable conditions. All results are documented on the test certificates and if the batch is compliant to the specifications, it is released.
Our products are manufactured and processed exclusively by qualified and certified partners. We maintain our long-term and trusting relationship with our cooperation partners and are constantly expanding our network.
The production of the individual components as well as the subsequent assembly of the parts into a fully functional system is carried out according to defined quality criteria in compliance with the GMP guidelines of the WHO. To ensure reproducible compliance with the defined high-quality standard, all necessary technical, organizational and structural measures are taken and checked by regular audits.
The facilities, production lines and test equipment are routinely cleaned, maintained and tested for proper performance. All production and control steps relevant to quality assurance are carried out according to defined work instructions and documented accordingly.