Preservative-Free

Historically used preservatives, such as benzalkonium chloride (BAC), are associated with tolerability issues in patients and can cause side effects. These can impair therapies for long-term or chronic use, e.g. glaucoma treatment in eye-care.

Sea water, eucalyptus or other natural decongestants, natural eye-drops, but also prescription medicines treating serious conditions are expected to be as pure as possible. This demand creates a growing need for preservative-free solutions for multidose products.

Due to skin inflammation of most chronic dermatologic diseases, additional sources of irritation -like preservatives- should be avoided. Consumers of skin preparations are used to see preservatives being eliminated from their cosmetic products (paraben).

Authorities all over the world have reacted to the obvious need for preservative-free solutions in health care and created stringent regulations and requirements when it comes to microbiological safety and integrity.

The Advanced-Preservative-Free system for nasal and topical use  (APF and APF^Plus)as well as Aptar Pharma’s Ophthalmic Squeeze Dispenser for preservative-free eye drop delivery (OSD), are provided with a set of data and test methods designed to support pharmaceutical customers in preparing the dispensing part of their finished product dossier.

Our purely mechanical Tip-Seal technology in combination with the metal-free fluid-path of our PFSs has been developed for use without preservatives and additives such as silver ions or surface coating. As such Aptar Pharma’s preservative-free technology platform provides well-established packaging solutions for sensitive formulations as well as for preservative-free formulations.

Along the market requirements and regulations we have developed microbial challenge procedures simulating relevant in-use scenarios. Customer formulations might require additional testing depending on the properties of their respective formulations.