Aptar Pharma, a global solution provider of innovative and proven aerosol, injection and spray delivery systems has obtained a State Food and Drug Administration (SFDA) import license to deliver its preservative free multi-dose systems to customers in China.

The license approval represents a further step in the company’s ongoing service development to provide large-scale production services to customers, mainly for its Ophthalmic Squeeze Dispenser (OSD) and its Advanced Preservative Freespray pump (APF).

The import of packaging materials for pharmaceutical products requires an “Examination and approval for packaging materials and containers in direct contact with drugs” from the SFDA before being placed on the market. Now that this import license has been granted for the Ophthalmic Squeeze Dispenser (OSD) and Advanced Preservative-Free Systems (APF), pharmaceutical and biotechnology companies can directly import Aptar’s preservative free multi-dose systems into the Chinese market.

The OSD is manufactured in a class ISO 7 clean room at its advanced production facility in Eingeltingen, Germany.

The company stated that the preservative-free systems are highly appreciated by patients who experience side effects from preservatives like benzalkonium chloride during chronic use. The APF spray pumps and the OSD systems follow a purely mechanical approach to prevent contamination via the orifice. The applied technology is referred to as ‘tip seal technology’ and well established on other markets.

A key element of the preservative-free technology is a spring-loaded tip seal that keeps the system closed until a defined pressure is reached during actuation and the formulation is dispensed through the orifice.

For the venting air, a sterile filter stops microorganisms from entering. The fluid path of these systems is ‘metal-free’, which means the springs needed for the device operation do not come in contact with the formulation. The technology is widely established and market proven in both nasal and ophthalmic applications.

In addition, the APF spray pumps and the OSD systems are designed to be patient-friendly and easy to use to help improve patient compliance with the medical treatment.

Aptar Pharma was one of the pioneers to be established in China since 1996 with a production site at Suzhou, near Shanghai to manufacture spray and aerosol drug delivery devices for this market. The site serves the majority of the local Chinese pharmaceutical companies, whether they are producing drug products for the domestic market or for other Asian regions.

 “We are pleased to announce the import license for the OSD technology and APF pump technology to China. There has been tremendous success in marketing these technologies in other regions of the world and we are confident that our customers and consumers in China will value the benefits of our preservative free systems”, said Matthias Birkhoff, vice president business development for Aptar Pharma CHC Division.