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The license approval marks another milestone in Aptar Pharma’s ongoing service development to provide large-scale production services to customers.
Aptar Pharma announced that it 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 enlarges Aptar Pharma’s service scope in the Chinese market and 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-free spray pump (APF).
The pharmaceutical sector is outpacing growth in developed countries. 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. The license approval enables pharmaceutical and biotech companies to import Aptar Pharma’s OSD and APF into the Chinese market. The OSD is manufactured in a class ISO 7 cleanroom at the company’s state-of-the-art production facility in Eingeltingen, Germany.
Preservative-free systems are particularly useful for patients who suffer side effects from preservatives such as benzalkonium chloride during chronic use. Aptar Pharma’s APF spray pumps and OSD systems use a mechanical approach to prevent contamination via the orifice.
The preservative-free technology, known as the “tip seal 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. As soon as the pressure drops, the tip seal immediately close the orifice by an outward movement, thereby, preventing 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 APF spray pumps and OSD systems are also designed to be patient-friendly. The 360° functionality of the APF spray pumps ensures convenient and safe handling, especially for pediatric use. Aptar Pharma’s OSD system is engineered for intuitive handling, smooth actuation, and precise and reproducible dosage, all with pocket-sized design.