Brevetti Angela SYFPAC® BFS technology advantages

Brevetti Angela’s renowned SYFPAC® range of Blow Fill Seal (BFS) machines are ideal for high speed production of pharmaceutical aseptic parenteral packaging of sterile liquids in small to medium volumes, thanks to their particular technological features that deliver unique advantages.

These distinctive advantages include greater flexibility and adaptability, easier operations with reduced downtime for tooling changes, and ability to more specifically tailor primary packaging format to individual product and market.

SYFPAC® technology and advantages 

SYFPAC is an acronym that stands for System for Filling Parenterals Aseptically into Containers. This proprietary Brevetti Angela system was developed by founder Francesco Consolaro based on his extensive expertise in plastic moldings and packaging. The system is based on BFS technology in which the plastic container is formed, filled and sealed all within the same machine in one single integrated process.

While some BFS platforms use a rotary mechanism, SYFPAC machines work on a shuttle technology: also known as open parison process, which involves shifting the mold from the forming position to the filling station. While both configurations deliver steady and reliable production, shuttle mechanisms have been preferred for their inherent machine flexibility in easy format changes, replacing inserts and parts of the mold.

SYFPAC user benefits

Brevetti Angela’s SYFPAC machines offer some highly useful user benefits that include:

• Custom Molds: SYFPAC machines are equipped with molds exclusively produced by Brevetti Angela based on customer specification of the final product and careful consideration of the polymers, products and chemicals that will be used. These allow ultimate flexibility to tailor shape, size and embossing of variable information to particular market needs. Molds are modular and can have up to 50 cavities, allowing production of different volumes with a simple change of inserts.
• Material flexibility: The unique SYFPAC® design allows the use of different types of polymer without changing molds or other complex operations. The same mold on the same machine will accept different plastic materials like PP, PE or HDPE, with choice depending on bottle design, product stability and end-user requirements. Changing polymers merely requires its recipe to be entered into operating system, with no need to dismantle the mold or change any parts.
• Customization: Each SYFPAC® machine is uniquely built to individual order, using top quality components and with the option to supplement standard features from a wide range of options such as possibility of black and white separation, addition of inert gas, recirculation loop for suspensions, modification for temperature sensitive formulations, inserts to emboss variable information, etc..
• Market-friendly container formats: The standard SYFPAC® design can be customized with a wide choice of optional items and functions. Custom-tailored shapes for the containers allow adjustment of head shape to specific product application. For vials and ampoules that means different types of luer connection, screw heads, or twist off openings. For bottles, a particularly innovative example is the patented Eco-head design, which brings an eco-friendly and economic solution to large volume parenterals packaging by eliminating the need of secondary capping.
• Parison Thickness Control: Thanks to its special engineering, SYFPAC® can control the wall thickness of the parison, allowing manufacture of containers from very rigid to those that are almost as lightweight and self-collapsible as flexible bags. This feature can reduce overall plastic consumption by up to 30%, compared to traditional machines.

In addition, the SYFPAC system confers all the generic advantages of BFS for pharmaceutical parenteral packaging that include:

• Contamination free with no human interaction
• Free of particulates
• Cost effective manufacturing solution
• Greater ease in matching product to ideal primary packaging format
• Integrated aseptic filling
• Longer product shelf life
• Easier logistics in supply, transport and storage
• Highly scalable production, from niche batches to large volume manufacturing

Brevetti Angela SYFPAC systems in application

Brevetti Angela’s patented SYFPAC® machines enable production of small volume (0.1ml to 20ml) parenteral plastic vials and ampoules, large volume (50ml to 1000ml) plastic bottles, or prefilled syringes in 0.5ml to 20ml sizes at high production rates

The SYFPAC® system is designed to perform reliably and precisely for 24 hours a day, 365 days a year. The machines’ smart and robust construction prevents frequent and expensive maintenance, with long service life further enhanced by Brevetti Angela’s integrated preventive maintenance program.

The system is also highly suitable for clean room environments up to Class C or D standards, being a single machine with compact footprint (36m²) with no need for ancillary container storage, washing, or container sterilization installations. Along with ease of automation, this also reduces personnel headcount in the production area.

Aseptic process conditions are guaranteed by Grade A sterile air shower during the filling and sealing steps. All process media are handled through pre-sterilized pipes, valves and absolute filters to comply with FDA and EU GMP guidelines. Clean In Place (CIP) and Sterilize in Place (SIP) processes are integrated and are automatically performed internally as standard and automated procedures.

SYFPAC® machines incorporate SCADA, HMI and automated control systems that capture, record and monitor all changes made to the machine operation parameters, with data integrity to FDA 21 CFR part 11 standards where necessary. The system also stores all alarm conditions generated during all phases of machine operation; and performs CIP & SIP, drying, and filter integrity tests automatically, while also providing automatic advance notifications and recordings of preventive maintenance activities.

SYFPAC® range

The Brevetti Angela SYFPAC portfolio includes four machines particularly applicable to pharma production and packaging:

• SYFPAC® SVP: for the aseptic primary packaging of Small Volume Parenterals, in the shape of vials and ampoules with volumes from 0.1ml to 20ml for vaccines, injectable, ophthalmic applications, etc., at up to 16,000 units per hour
• SYFPAC® TWIN: double-decker BFS aseptic primary packaging of Small Volume parenteral 0.1ml to 20ml vials and ampoules at up to 27,000 units per hour: 60% increase in production capacity on same SVP footprint.
• SYFPAC® LVP: for the aseptic primary packaging of Large Volume Parenterals in plastic bottles from 50ml to 1000ml for IV, irrigation, saline and other applications at up to 2,750 units per hour.
• SYFPAC® SECUREJECT®: for manufacturing of prefilled syringes PFS and injection devices using BFS technology at up to 8,400 units per hour. Prefilled syringes can be squeezable for single use, or standard with inserts, from 0.5ml to 20ml.

These machines form the bases for complete packaging lines when combined with MASEP trimming unit or MECAS cap assembling and cap sealing units. The system can also be expanded with a MAVAC unit to automatically collect, grind, and shred plastic scrap produced by the SYFPAC® machine, reducing it to granules ready to be fed back into the process.

Resources

Click on SYFPAC® from Brevetti Angela for details of whole product range.
Click on SYFPAC Videos to watch SVP and LVP systems in action.
Click on BFS Technology  for explanation of the Blow-Fill-Seal process.
Click on BFS Containers for full range of package format options.