Brevetti Angela SYFPAC® BFS for Small Volume Parenterals

Brevetti Angela’s SYFPAC® technology for Blow Fill Seal (BFS) packaging is highly suited to flexible aseptic fill and finish primary packaging of Small Volume Parenteral (SVP) vials, ampoules, injectables, droppers and other formats.

Designed for volumes ranging from 0.2ml to 50ml, SYFPAC® SVP is suitable for production of single use containers, as well as vials for multi-dose applications.

Machine Design

SYFPAC® SVP is suitable for single- or multi-dose containers.  Brevetti Angela’s moulds are designed and produced in house, so that they adapt to an extensive variety of shapes and sizes based on the specific needs of the product and its application. Being modular, the moulds allow a quick and easy changeover among different formats, for example 2ml, 5ml or 10ml. The system also allows for special embossing or label spaces to be incorporated for labelling.

The compact machine footprint allows for reduced clean room dimensions of only 36 sqm (5.2m x 6.4m) with just over 3m headroom, while the inherent SYFPAC® containment means that only class C or D cleanroom standards are required. There is also the option for Ultraclean technology, which separates black and white areas of the room, to further decrease the dimensions requirements.

Each SYFPAC® SVP machine can produce up to 16,000 units per hour, upgradeable to as much as 25,000 uph on the same machine, with no increase in clean room requirements. Suitable for mass production, the machine can work 24/7. Robust construction combined with a smart preventive maintenance program, prevents failures and unexpected corrective maintenance.

Flexibility and Adaptability

SYFPAC® can use PP, PE or HDPE polymers, to suit a wide range of formulations and provide vials/ampoules with optimal resistance to terminal sterilization as well as excellent long term product stability and shelf-life. Containers can range from very rigid to lightweight, from transparent to opaque, depending on the product requirements. The shape of the container will also be determined by product requirements, with a wide choice of designs both for the body and for the head of the vial or ampoule. Depending on the need for secondary capping, some examples of head closure design can be luer slip, luer lock, screw or twist off head.

SYFPAC® machines feature precise parison thickness control to decrease plastic consumption by up to 30% compared to traditional machines. Vial squeezability is also improved, providing a better usability.

SYFPAC® SVP is suitable for filling solutions at temperatures from 4°C to 30°C and can also be adapted for packaging heat-sensitive products like vaccines and biologicals, as well as solutions with higher viscosities and possible foaming properties, while its recirculation systems can be designed for suspensions.

Small Volume Parenteral Applications

SYFPAC® Blow-Fill-Seal packaging can be applied to almost SVP parenteral application that requires a single use sealed vial, ampule or small bottle container, including sets of containers for multidose formats.

• Vaccines: including biologicals
• Ophthalmics: droppers and irrigations
• WFI: Water for injection ampoules for injectables, diluents, and solutions for reconstitution
• Enemas: including douches
• Suspensions: including antibiotics and anti-inflammatories
• Sprays: Nasal sprays or aerosol preparations.

In addition, Brevetti Angela has developed SYFPAC® technology to provide the same BFS advantages to the production of prefilled syringes, as a special design of vials with a simple insert can turn it into prefilled syringes for single use For further innovations on the design of prefilled and prefillable syringes, Brevetti Angela has also started a partnership with sister company 3CK.

Resources

Click on SYFPAC® SVP Technical Specifications to download data sheet.
Click on SYFPAC® Videos to see SVP and LVP systems in action.
Click on BFS Containers for full range of package format options.
Click on Brevetti Angela SYFPAC® BFS Technology for further information.