Aptar's multi-dose approved for China

Aptar Pharma has obtained a State Food and Drug Administration (SFDA) import license approval to deliver its preservative-free multi-dose systems to customers in China.

The license approval is part of the group's service development plan to provide large-scale production services to customers, mainly for its Ophthalmic Squeeze Dispenser (OSD) and its Advanced Preservative Free spray 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 approval has been granted for the Ophthalmic Squeeze Dispenser (OSD) and Advanced Preservative-Free Systems (APF), pharmaceutical and biotechnology companies can directly import Aptar Pharma’s preservative free multi-dose systems into the Chinese market.

The OSD is manufactured in a class ISO 7 cleanroom at the Aptar Pharma production facility in Eingeltingen, Germany.

Preservative-free systems are used 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 is well established in other markets.

A key element of Aptar Pharma’s 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. When the pressure drops consequently, the tip seal immediately closes the orifice by an outward movement, which prevents any back-flow of contaminated liquids or particles.

For the venting air, Aptar Pharma uses a sterile filter to stop 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.

“We are pleased to announce the import license for the OSD technology and APF pump technology to China. We have had tremendous success 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. As with any of our technologies, we continue to invest in ways to even further improve our devices as we adapt to our customers’ future needs and expectations”, said Matthias Birkhoff, Vice President Business Development for Aptar Pharma CHC Division.