Pharma advantages for Brevetti Angela SYFPAC® BFS technology

Brevetti Angela’s SYFPAC® technology for Blow Fill Seal (BFS) packaging delivers compelling advantages for pharmaceutical manufacturers, particularly in its application aseptic fill and finish processes.

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 Blow-Fill-Seal Technology

SYFPAC^â is short for System for Filling Parenterals Aseptically into Containers and as its name suggests, it was developed with the pharma industry specifically in mind. 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.

This means that the whole process is inherently contained and isolated and takes place on a smaller overall machine footprint. SYFPAC machines ensure continuous production thanks to their robust construction and smart preventive maintenance programs, so that they are suitable for high production of aseptic pharmaceutical products. Their moulds are meant for Small Volume Parenterals like vials or ampoules, or Large Volume like bottles.

Since the moulds are modular, their parts can easily be removed and replaced for quick format changes taking less than two hours, while the complex mould changing procedures required on multi-mould rotary machines means format changes require longer production stops and may involve technical assistance.

Inherent aseptic fill advantages

The BFS process is inherently ideal for high-speed production of pharmaceutical aseptic parenteral packaging of sterile liquids and gels in small to medium volumes, thanks to its basic technological features.

Thus, SYFPAC machines offer a series of powerful basic positives:

• Protection of product from contamination
• Cost-effectiveness of the manufacturing process
• Scale production economies
• Longer shelf life without preservatives
• Flexibility in volumes and shapes to accommodate functional and aesthetic requirements
• Logistic savings from use of virtually unbreakable plastic containers that are lightweight and easier to store and transport
• Better process optimization.

At the same time, the BFS process negates traditional problems in aseptic fill-finish production:

• Lower risk of contamination from minimal human interaction
• Reduced probability of particle contamination
• Smaller clean room space requirement: only 36m² of floorspace to Class 3 environmental standards
• Fewer machines required with no need to handle, wash, or sterilize pre-made containers
• Lower personnel headcount
• Elimination of most packaging sourcing, procurement, supply and storage issues.

Specific SYFPAC benefits

The special design allows Brevetti Angela’s SYFPAC machines to offer some highly useful user benefits that include:

• Custom Molds: SYFPAC machines are equipped with modular molds in which the bottom, neck and head inserts can be interchanged, with up to 50 cavities available to allow production of different volumes and formats with a simple change of inserts. Modules can be specifically tailored to customer product lines and allow ultimate flexibility to tailor shape, size and embossing of variable information to individual needs.
• Material flexibility: The unique SYFPAC® design allows the use of different polymer types (PP, PE, HDPE) without changing molds or other complex operations. 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, modifications 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 include configuration of head shape to the product application including luer connection, screw heads, or twist off openings, as well as Brevetti Angela’s unique Eco-head bottle design that eliminates need for secondary capping on large volume parenterals.
• 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%.

Summary

There are two main reasons why BFS technology is experiencing such a rapid uptake in the pharmaceutical world:

1. BFS enables high quality and completely sterile packaging at a very reasonable cost and without the need for complex packaging lines.
2. The technology is highly adaptable and can be applied to all parenteral formats, including vials, ampules, small and large bottles or flasks and now prefilled syringes as well.

As well as the direct savings on materials and less demanding process, there are also a host of other factors that reduce overall TOC, such as lower cost production facility, shorter supply chain, and savings all along the logistics chain.

Resources

Click on Brevetti Angela SYFPAC® Advantages to learn more.
Click on Brevetti Angela SYFPAC® BFS Technology for further information.
Click on SYFPAC Videos to watch SVP and LVP systems in action.
Click on BFS Containers for full range of package format options.