By Brevetti Angela…
Leading-edge BFS SYFPAC® DUO™ from Brevetti Angela
Brevetti Angela’s new SYFPAC® DUO™ represents the major advance in Blow Fill Seal (BFS) packaging technology for the pharma industry. This revolutionary BFS platform combines container formation, aseptic filling and sealing into one continuous operation that can be carried out from a tiny footprint.
The SYFPAC® DUO™ incorporates leading-edge technologies to make it the fastest, smallest, safest, and most efficient Blow Fill Seal machine on the market and one that is also suited for cool production of vaccines and biologic products.
DUO™ technologies
The DUO™ takes SYFPAC® BFS aseptic filling and packaging a major step further with its Closed Parison Technology in which containers are formed, filled, and sealed in the same position and under Grade A aseptic conditions in an isolated system. EU GMP Annex 1 ready. This new machine also breaks a new ground: Insertion Technology in a Closed Parison machine to support sterile production of prefilled syringes, multi-dose eye droppers and other innovative and cost-effective drug delivery devices within the closed parison.
This is a ‘best of both worlds’ advance that for the first time combines the versatility and operational advantages of the previous SYFPAC® shuttle system with the aseptic advantages of closed parison, now allowing insertions as well.
Sterile production is taken a stage further with the groundbreaking DUO™ Process Monitoring System that ensures that DUO™ can comfortably exceed EU GMP Annex 1 standards.
Engineered for flexibility and cost-effectiveness
The modular design allows the same basic machine to be seamlessly upgraded in easy stages from micro-scale at 4,000 units per hour, through mini-scale at 10,000 units/h, max-scale (20,000 units/h) up to hyper-scale at 40,000 units/h, or 230 million doses per year. This does not require adding modules, merely small internal changes so that the DUO™ retains its tiny cleanroom footprint.
While total width/depth dimensions for DUO™ are 1.4 m x 4.5 m with an overall height of 2.6 m, only the front part (1.5 x 4m x 2.6m) needs to meet Class C standards, taking up only 6m2 of cleanroom floor space. This gives DUOÔ the highest productivity-to-size ratio of any BFS machine on the market. Furthermore, the modular design allows high layout flexibility including single-room, on-board, or a ‘black-and-white’ configuration.
The DUO™ is also designed for flexibility in operation with fill volumes ranging from 0.2 ml up to 50ml, the ability to process polyethylene (PE), polypropylene (PP) or High-density polyethylene (HDPE), without any hardware changes, only requiring recipe changes in the HMI operating interface. Mould changeovers can be accomplished in under ten minutes in a simple operation that does not require any special tools nor a technical intervention.
Cool and clean
The machine is also notable for its ‘cool’ credentials, supporting cold production of biologicals and vaccines at under 25°C, which is unprecedented for a BFS Closed parison machine. The DUO™ is, therefore, an ideal solution for producers of temperature-sensitive vaccines, injectables, eye drops, biologicals, inhalation devices, small-volume parenterals. The DUO™ is also containment-ready for highly potent or toxic products requiring BSL level 4 isolation.
Hygiene is also built-in with fully-electric operation in which all movements are driven by servo motors (no hydraulic oils needed) and an easy-clean form factor to meet Pharma demands.
Sustainable
Brevetti Angela’s proven Extrusion Technology with the longest plastic residence time in the industry allows the DUO™ to be exceptionally resource-efficient, offering the industry’s lowest plastic granule consumption, with scrap reduced below 6%. For a high-volume producer, this can add up to savings of $900k per year in plastics raw materials alone.
Cost-effectiveness is also assured by the overall DUO™ proposition of up to 2.5 times greater production, using one-third of the floor space compared to shuttle machines.
The new platform’s versatility means that DUO™ can replace Brevetti Angela’s existing SYFPAC® SVP, and SECUREJECT™ platforms for aseptic filling of small volume parenterals and prefilled syringes respectively since it can handle both applications in one machine.
Resources
Click on Brevetti Angela SYFPAC® BFS Technology for further information
Click on BFS Containers for full range of package format options