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Unither Pharmaceutical has grown since 1993 to become the world leader of sterile unit dose manufacturer, using the Blow Fill and Seal (BFS) technology. Today, the company has five manufacturing plants and one R&D center, located in France and in the USA. The position of adopting the BFS technology very early has participated in developing and commercializing the offers in single-dose products that simplify the administration of drug products to patients.
Unither Pharmaceuticals is, annually, manufacturing more than two billion vials in BFS. The Blow/Fill/Seal (BFS) is an advanced aseptic process and recognized in the GMP’s. The companies are, on a regular basis, inspected by the FDA and European authorities who allow the company to sell the products in more than 80 countries across Europe, USA and China. The technology and the process are so well accepted that this is participating to the expanding of capacities of the companies with the installation of new BFS lines.
Expanding the lead in BFS
In October 2013, Unither acquired the former UCB Pharmaceutical facility located in Rochester, New York, US, to support its strategic plans for expansion. This FDA and DEA-inspected facility will drive growth for Unither in North America by bringing the capacity closer to the world’s largest pharma market.
The Rochester facility has expertise in developing and manufacturing oral solids and liquids, (OTC and Rx products) with extended and controlled release profiles while adding single-unit dose capabilities. The expansion includes the installation of a BFS machine in 2015, followed by the first high-speed commercial BFS line the following year. This added capacity will support Unither’s expansion into the asthma and ophthalmic markets for preservativefree, sterile-fill liquid products in North America.
Its Coutances and Amiens facilities in France, meanwhile, will be continuing to expand the company’s BFS capacity by adding new commercial lines in 2015 and 2016. With the ability to provide capacity for unit doses of 0.25–20ml, Unither can quickly meet pharmaceutical partners’ needs in the areas of ophthalmology, respiratory, rhinology, otic care and antisepsis, or wound cleaning.
Blow/Fill/Seal (BFS) is an Advanced Aseptic process that performs the primary packaging for a wide product variety: nebulized inhalation drugs, ophthalmic OTC products and drugs, and small volume injectable products. It is an automated process where plastic resin is extruded and formed into a container. The container is then filled and hermetically sealed. The entire process is performed in a controlled environment and completed within 4 to 15 seconds. The Blow Fill Seal technology was developed in Europe in the 1950s and was introduced to the US three decades later. BFS is a continuous, robust means of filling aseptic preparations of sterile pharmaceuticals.
With properly maintained and operated systems the technology provides a container that does not have the particle contamination that is inherent to preformed containers. Since the containers are not formed and transported to the filling place the need to decontaminate BFS containers is eliminated. BFS containers do not need to be washed because the particles found in preformed containers do not have a mechanism to be introduced to the BFS container. Tests have shown that particles present in the environment do not find their way into a BFS container during the filling process. The BFS single-dose vial is currently the most popular container of its type in Europe for new ophthalmology treatments, as it eliminates preservatives, such as benzalkonium chloride, and is increasingly used when reformulating existing products. BFS vials are easy to carry and ready to use, making them a great fit for today’s active lifestyles. They provide a number of advantages, including the ability to dispense accurate single doses without measuring devices, portability, the elimination of preservatives, and improved hygiene.
Lab to plant
Based on the two decades of experience in developing formulations for new chemical entities (NCE), the BFS can be evaluated with Unither Pharmaceuticals to establish commercial and generic drug substances. In the BFS, plastic resin has minimized additives giving it a relatively clean extractable profile.
Initial compatibility test is possible in lab setting by filling the product into empty sterile BFS containers made out of LDPE, the typical resins used in the BFS process on machines. Once basic compatibility test is confirmed the next step is to test the product on BFS machines, this is what, also, can be provided. BFS easily matches with Regulatory Affairs: EMA Investigational Medicinal Product Dossier (IMPD), FDA New Drug Application (NDA), FDA Abbreviated New Drug Application (ANDA). The BFS is a single way to deliver drug products to a global market.