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

Individual services for your advanced preservative-free products

Ursatec Verpackung GmbH is your partner for all challenges associated with the application of preservative-free pharmaceuticals, medical devices and cosmetic products. Through our experienced project management and well-established supply chain, we are able to provide finished products ready to sell.

You can count on us for complete service packages or single components only.

Product Development: Solutions for pharmaceuticals, medical device and cosmetic products

Product development

Solutions for pharmaceuticals, medical device and cosmetic products

Ursatec’s partnerships with contract development organizations are the basis for offering professional expertise to our customers. Together with formulation specialists, Ursatec supports its clients in creating new application paths for innovative pharmaceutical and cosmetic products.

Step by step, we lead you through the product development, starting with developing the formulation via small scale test fillings up to the final product ready to sell. All operations of course fulfill the requirements of the relevant international guidances such as e.g. the EMEA guideline.

Documentation

Get your analytical file ready for submittal

Even at the beginning of the formulation development, it is necessary to clarify the registration questions concerning the pharmaceutical quality of products such as inhalation or nasal sprays. The same considerations must be made when revising a formulation for a new registration. To file for registration, many documents are required by the authorities. The necessary quality documentation includes the following data:

  • Composition and formulation development
  • Manufacturing controls
  • Quality control of the raw materials
  • Finished product including stability tests

Material provision

Raw material provision for primary packaging

All raw materials are sourced in standard quantities from qualified suppliers. The material’s quality, e.g. conformity with common requirements with respect to food-contact, pharmacopeial requirements, REACH, etc., as far as applicable, is defined by comprehensive specifications. The safety of all polymers and colouring materials used for the manufacture is assured by corresponding certificates of the suppliers. Prior to use for manufacture, each material batch is subjected to at least an identity test.

Sterilization

Proven, reliable and validated processes

The individual components of the Ursatec systems, pumps and bottles, are sterilized according to validated procedures in compliance with respective norms and standards. The ethylenoxide sterilization was shown to be a particularly suitable sterilization procedure for the systems, as this procedure is very safe, reliable and mild with respect to the materials. Upon completion of the sterilization cycle, the goods are subjected to desorption in specific desorption cells under validated conditions ensuring that the residual ethylene oxide (EO) and ethylene chlorhydrine (ECH) are below the tolerance limits of the respective norms and directives. The sterilization is exclusively carried out at qualified and certified partner companies, which are subjected to regular audits.

Sterile filling

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

Best standards – clean room class A

For the production of today’s most challenging preservative-free products, Ursatec has qualified the best partners to meet the high quality standards these products create. The filling machinery of our partners operates in a clean room class A environment which is designed by a team of scientists and engineers in consultation with industrial and regulatory experts. They incorporate those special engineering design concepts and control systems for aseptic filling in order to guarantee full microbiological protection of the preservative-free product.

Their facilities include:

  • Experienced and well-trained dedicated staff
  • Air handling system with HEPA- filtered air
  • Raw materials sealed until arrival in filling suite

Together with its partners, Ursatec offers a full service concept delivering a completely finished product to the customer ready to sell.

Lab services

Single components or full service

Laboratory services provided by Ursatec and its partners comply with strict international standards. This creates the essential basis for the successful approval and sale of your pharmaceutical product in national and international markets. Ursatec offers laboratory services through its partners that range from the preclinical phase all the way to the market approval of your pharmaceutical products. You can count on us for complete service packages or individual service components, including

  • Development and validation of methods
  • Stability testing and storage
  • Testing of raw materials
  • Complete service packages for batch release
  • Analytical services upon request

Downloads

Here you can find our current brochures and folder as PDF files.

Ursatec's dosage systems

Ursatec dosage systems

Individual services, quality and technical details

Ursatec service

Dosage systems for preservative-free dermal application

Dosage systems for preser­vative-free dermal appli­cation

Dosage systems for preservative-free cosmetics

Dosage systems for preser­vative-free cosmetics

Dosage systems for preservative-free inhalation

Dosage systems for preser­vative-free inhalation