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Rommelag Engineering BFS bottelpack sterile pharmaceutical primary packaging for vaccines
Rommelag Engineering’s bottelpack filling machines that use the Blow Fill Seal system to purpose-made to fill plastic bottles, vials and ampules in one integrated operation can provide pharma companies with a key solution in meeting the current challenge of producing COVID-19 vaccines and therapies at global scale within a very short timeframe.
Bottelpack machines using BFS technology offer a solution to many of the production problems confronting vaccine manufacturers. This continuous aseptic packaging technique combines high production efficiency with high sterility assurance to produce vaccine containers and prefilled syringes that can be quickly distributed and administered.
The COVID-19 pandemic has placed the biopharmaceutical industry under acute pressure to drastically reduce the time to market of vaccines now in development. While the research and testing challenges are widely understood, the many production challenges are less well appreciated. For example, the active ingredients are typically highly sensitive and must be protected against shocks, temperature excursions or undesired interactions with the pharmaceutical primary packaging. Added to this are small batch sizes that markedly complicate adequate scaling of production in favour of the widespread need for new vaccines.
Rommelag has worked intensively over the past decade to develop BFS technology for the packaging of biological products, with various vaccines and other biotech products successfully filled at its Biosafety level 2 (BSL-2) validated BFS plant at Rommelag CMO in Switzerland.
coolBFS for heat-sensitive biologicals
While standard BFS processes are performed at room temperature, Rommelag’s coolBFS technology for bottelpack machines protects the potency of heat-sensitive ingredients used to manufacture vaccines.
The coolBFS system keeps the product at a predesignated temperature and uses special mechanisms to quickly cool newly moulded containers before filling.
BFS vaccine packaging benefits
Rommelag bottelpack machines using BFS technology offers a continuous aseptic packaging technique combining high production efficiency with high sterility assurance to produce tamper-proof single dose vaccine delivery systems that can be manufactured at low cost and at global scale.
Other advantages include filling volume of up to 1 ml, formation from mono-material LDPE resins, very high sterility, a highly automated process, compatibility with temperature-sensitive product, minimizes risks for people and the environment, and a proven and cost-effective production system with single machine capacity of up to 35,000 units per hour.
BFS aseptic packaging of vaccines into prefilled syringes
Recent innovations have made it possible to use BFS aseptic packaging technology to produce prefilled syringes of single-dose vaccines in a quick, hygienic, and cost-effective, making them easier and faster to bring to market.
By blow molding, filling, and hermetically sealing a ready-to-administer syringe with an exact unit-dose, the bottelpack system can eliminate many supply chain issues that may otherwise slow the production and distribution of approved vaccines. The resulting non-glass prefilled syringes are sterile, lightweight, can be administered immediately, and disposed of safely.
Rommelag has been working with a notable leader in this field, ApiJect, co-founded by injection safety champion Marc Koska, OBE, whose mission is to make medical injections safe and available for everyone by replacing conventional multi-dose glass vials with safer injection formats that cannot be reused or contaminated.
By marrying a BFS-formed and filled syringe body with a simple push in needle hub, ApiJect has produced a vaccine delivery system that a single BFS manufacturing line can produce at the rate of 15 million finished doses per month at packaging cost far lower than 10-dose vial and syringe. ApiJect has joined forces with the U.S. Government to create The RAPID Consortium, a public-private partnership to strengthen American and global surge capacity (see Resources). Its BFS Prefilled Syringe will debut later this year as part of the US Federal Government’s COVID-19 response. ApiJect believes that soon any pharmaceutical company will be able to fill-finish their injectable drugs in new ultra-low-cost prefilled syringes with to complete cGMP aseptic quality standards.