URSATEC GmbH

URSATEC GmbH is an innovative development and sales organization that specializes in spray dosage systems for preservative-free solutions.

Its comprehensive single-source offer encompasses product development, material sourcing, patented dosage delivery systems, aseptic filling, laboratory validation, regulatory support and the supply of finished products.

Vision & Mission

Over more than three decades, URSATEC has been committed to providing innovative packaging solutions that enable the elimination of preservatives, as defined in its corporate motto: ‘When Preservative Free Matters®’, which also encapsulates its guiding vision of preservative-free solutions benefiting human health and the entire pharma value chain, from raw materials to finished products.

The company’s mission is to support the global healthcare industry in providing purer products by developing and distributing dosing systems and safe, effective, as well as well-tolerated finished products designed for preservative-free delivery.

The URSATEC corporate ethos is also based on sustainability, striving for continuous improvement by optimizing processes, advancing product development, and fostering partnerships with customers and suppliers to enforce the highest standards of safety, efficacy, and environmental responsibility.

Activities & Products

URSATEC offers a comprehensive suite of services providing preservative-free solutions to four principal sectors: Pharmaceuticals, Medical Devices,  Cosmetics, and Food Supplements.

Its ONE Source® portfolio guides clients through every stage of development for preservative-free applications with services that include:

• Product Development: Creating innovative pharmaceutical, medical, and cosmetic white-label products for own branding, ensuring safety, efficacy, and market readiness with ‘Made in Germany’ quality.
• Raw Material and Procurement: Source management for high-quality ingredients and components, ensuring compliance with industry standards and regulatory requirements.
• Dosage Systems: Providing solutions like 3K® and COMFORT® technologies, tailored for various applications including nasal, oral, dermal, and otological uses.
• Sterilization and Aseptic Filling: Ensuring product sterility through validated sterilization processes and aseptic filling techniques
• Laboratory Services: Providing comprehensive testing, validation, and verification services in collaboration with certified laboratories
• Regulatory Support: Guiding clients through complex product registration, compliance, and approval processes.

Many URSATEC white-label offerings are based on its proprietary technologies for preservative-free dose delivery.

The 3K® System is a non-airless multi-dose system designed for liquid pharmaceutical formulations that employs a microbiologically tight-closing valve and bacteriostatic surfaces in the nozzle to prevent contamination, making it suitable for nasal, oral, dermal, and otological applications.

The COMFORT® System is an airless multi-dose system and is ideal for dispensing liquid and semi-solid formulations featuring a flexible inner bag that collapses as the product is dispensed, eliminating the need for air intake and reducing contamination risk in nasal, oral, dermal, and otological applications.

In addition, URSATEC solutions can be applied to inhalation and breathing aids, food supplement dispensers, cosmetic ointments and gels, lip and eyelid relief, intimate care sprays, and pharmaceutical dosage of drugs such as xylometazoline, oxymetazoline, and corticosteroids.

Structure and Background

URSATEC GmbH was founded in 1993 with the development of its first propellant-free dosage system suitable for preservative-free contents, making it a pioneer in the field. Since then, the company has sold around two billion units worldwide and established itself as a market leader in preservative-free solutions for the global healthcare industry.

The company is headquartered in Tholey, north of Saarbrücken in southwest Germany’s Hunsrück region. Its organization and product offerings are enhanced by strategic partnerships with key industry players, such as Aero Pump for supply of pharma application systems, Gaplast for high quality plastic bottles, and URSAPHARM for sterile aseptic filling.

URSATEC leadership is headed by Dr. Andreas Bilstein as Managing Director of Marketing and Sales, as well as Finished Product Development, along with Horst Zimmer, Managing Director of Quality Management and Administration, and Packaging Development.

Quality, Regulatory and Standards

URSATEC implements rigorous and comprehensive Quality Assurance processes to ensure the safety, efficacy, and reliability of its systems and products. Its Quality Management System encompasses in-process controls for continuous monitoring of quality-relevant parameters, automated inspection of critical functional and safety features, microbiological safety testing, and sterilization processes. All production and quality control steps are meticulously documented. Test results are recorded in certificates, and only batches meeting all specifications are approved for release. URSATEC QA also extends to its collaboration with certified partners, ensuring that the whole supply chain conforms to WHO GMP guidelines, including state-of-the-art production facilities and cGMP cleanrooms for sterile production and filling of liquid and semi-solid dosage forms.

URSATEC ensures all its activities and products comply with the most stringent regulatory and quality standards, with certifications and regulatory validations for standards that include ISO 13485:2016, ISO 9001:2015, DIN EN ISO 15378:2017, MDR EU2017/745, and DMF drug master files for various regulatory regimes, including North America and China.