BFS SYFPAC® DUO engineering installation

Vicenza, Italy: – Innovative force in Blow-Fill-Seal (BFS) pharma packaging machinery, Brevetti Angela Srl, now has its groundbreaking SYFPAC® DUO system in operation in its own Clean Room at the Arzignano facility.

The SYFPAC® DUO installation in the Clean Room allows Brevetti Angela to carry out proving tests of manufacture trial batches of small volume parenterals (SVP) containers, including prefilled syringes, with unprecedented speed while keeping the same standards as in the highest quality pharmaceutical facilities.

SYFPAC® DUO’s modular construction and highly compact footprint allowed the installation to be carried out in under four weeks, with only three months elapsed from beginning of the project to full high-speed operation in a fully configured Class C clean room, constructed specifically for the project.

Aseptic proving

The Vicenza clean room facility uses a SYFPAC® DUO fully scaled up from its base ‘micro’ configuration (4,000 units per hour) to its full-scale Hyper configuration at ten times the output. In this form, a single SYFPAC® DUO would allow a pharmaceutical manufacturer to produce 264 million doses a year. The scale up is simply achieved with an internal upgrade inside the machine which does not change its footprint yet dramatically increases the output up to 10 folds.

The main purpose of the installation is to allow Brevetti Angela engineers to carry out proving and development tests under clean room conditions and for the regulatory support team to produce supporting validation and documentation. Initial tests have focused on proving SYFPAC® DUO’s aseptic fill and finish capabilities, benchmarked against EU Annex 1 requirements and other GMP guidelines.

In the longer term, it is planned to give Brevetti Angela customers access to the facility, so that they can carry out their own filling and other trials.

Clean room friendly

Brevetti Angela Technical Sales Expert Ajay Kabbur says the installation has already yielded valuable learning points.

“We have been able to experience at first hand the challenges of performing service, changes and maintenance in a validated clean room. This is all part of our mission to ensure SYFPAC® DUO is engineered to be both clean room and user friendly,” Mr. Kabbur explained.

“Part of the original design brief for SYFPAC® DUO was that it had to help operators and maintenance teams by being simple to operate and to service with minimum basic tools,” he added.

Revolutionary Blow Fill Seal

SYFPAC® DUO was first introduced to the pharma industry in enclosed form at last year’s CPHI Worldwide Pharma Expo in Milan and Brevetti Angela has plans to use its seventh successive CPHI Europe appearance at this autumn’s Frankfurt show for a further SYFPAC® DUO event.

Since making its debut, SYFPAC® DUO has made a major impact in the pharma industry as the ‘Fastest, Smallest, and Safest Blow Fill Seal machine’ on the market, due to its advanced capabilities.

The SYFPAC® DUO is a revolution in the Blow Fill Seal world, as it introduces the Closed Parison technology that allows containers to be formed and filled under Grade A conditions in a closed system, not only meeting but exceeding EU GMP Annex 1 requirements. SYFPAC® DUO also breaks new ground in incorporating Insertion Technology that enables aseptic production of new and cost-effective drug delivery devices such as prefilled syringes, multidose eye droppers, etc.

It also boasts a ‘world first’ with its groundbreaking process monitoring system that can deliver real time particle measurements from inside the parison, as well as support for cold production of biologicals and vaccines at well under 25°C, which is unprecedented in a closed parison Blow Fill Seal machine.

About Brevetti Angela

Brevetti Angela Srl is one of the world’s leading manufacturers of pharma primary packaging machinery, specializing in the production of Blow Fill Seal (BFS) machinery for the aseptic packing of liquids in purpose-formed plastic bottles, vials, and parenteral forms. Brevetti Angela platforms are ideally suited to the aseptic filling of pharmaceutical solutions and can also be applied to food & beverages, cosmetics, or cyanoacrylates filling.

Founded by Francesco Consolaro in 1977, the company remains based in Arzignano, in the province of Vicenza in north-eastern Italy. Over more than four decades, Brevetti Angela has been guided by a vision of following a path of continuous innovation based on ensuring customer satisfaction and quality of finished products, with a mission to provide primary packaging solutions that are flexible, versatile, reliable, and easy to maintain.

The company is particularly known for its range of advanced and patented SYFPAC® BFS machines designed and engineered to achieve the highest quality aseptic packaging of sterile pharmaceutical fluids for small-volume vials, bottles, and pre-filled syringes.

One of the key enablers for very high quality at Brevetti Angela is its emphasis on keeping all vital processes ‘in-house’ at Arzignano where all facilities meet CE standards and since 2008 have been certificated to ISO 9001:2008 quality standards.

Learn more at: www.brevettiangela.com

Resources

Click on Closed Parison Technology for further information.
Click on Smart as DUO to learn more.