Gains an import licence from the State Food and Drug Administration (SFDA)
Aptar has obtained an SFDA import licence for its preservative-free multi-dose systems
Aptar Pharma, a provider of aerosol, injection and spray delivery systems for biotech, healthcare and pharma products, has obtained a State Food and Drug Administration (SFDA) import licence which allows the company to deliver its preservative-free multi-dose systems to customers in China.
Aptar said the licence represents a further step in its ongoing service development to provide large-scale production services to customers, mainly for its Ophthalmic Squeeze Dispenser (OSD) and Advanced Preservative Free spray pump (APF).
In China, 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 Chinese regulator. With this licence, pharmaceutical and biotechnology companies can now directly import Aptar Pharma’s preservative free multi-dose systems into the region.
The OSD is manufactured in a class ISO 7 cleanroom at Aptar Pharma's facility in Eingeltingen, Germany.
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, 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 micro-organisms from entering. The fluid path of these systems is 'metal-free', which means the springs needed for the device operation do not come into contact with the formulation. The technology is established and proven in both nasal and ophthalmic applications, the company said.
In addition, the APF spray pumps and the OSD systems are patient-friendly and easy to use to help improve patient compliance. The 360° functionality of the APF spray pumps ensures convenient and safe handling; especially for paediatric use. The OSD system is engineered for intuitive handling, smooth actuation and precise and reproducible dosage, all in a pocket-sized design.
Aptar Pharma Suzhou was established in 1996 and produces pMDI metering valves and spray pumps for the Asian 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.