Brevetti Angela brings risk and knowledge management insights to BFS IOA Asia/Pacific

Vicenza, Italy: – Leading manufacturer of high-technology pharma packaging machinery, Brevetti Angela Srl, extended its presence within the Blow-Fill-Seal International Operators Association (BFS IOA) with a key knowledge contribution to the BFS IOA Asia/Pacific meeting in Yamagata, Japan.

As a long-standing member of the BFS IOA, Brevetti Angela has co-sponsored all association events for more than a decade. Once again, it contributed to the scientific and technical agenda in Yamagata, with Technical Sales Manager Massimo Consolaro delivering a presentation during the full-day conference session on the afternoon of December 4th.

Enhanced risk management with SYFPAC® DUO

Mr. Consolaro’s presentation, “How Pharma Companies and OEMs Can Benefit from Risk and Knowledge Management,” highlighted the importance of complying with the most rigorous GMP aseptic packaging standards, as recently updated in the EU Annex 1 guidelines.

These guidelines underline the need for data confirming that critical zones of internal Blow-Fill-Seal filling processes maintain Grade A aseptic conditions, and that viable environmental monitoring should be risk-based and aligned with Section 9 of Annex 1. In operation, viable particle monitoring is expected to run throughout the full duration of critical processing, including equipment assembly.

Historically, this level of viable monitoring has not been fully achievable on rotary-type BFS machines. That has now changed with the introduction of Brevetti Angela’s latest SYFPAC® Blow-Fill-Seal platform, the revolutionary SYFPAC® DUO.

Integrated process monitoring

Mr. Consolaro demonstrated how SYFPAC® DUO advances risk and knowledge management in Blow-Fill-Seal production through a suite of innovative features, including fully integrated Grade A aseptic isolation inside a closed parison and the sophisticated SYFPAC® DUO Process Monitoring System.

SYFPAC® DUO can continuously monitor total airborne particles in real time during operation via its on-board control system. It also supports risk-based viable monitoring, even though—as a closed-parison machine—this is not explicitly required under Annex 1. An active air sampler for viable monitoring can be connected to the machine, sampling air from the filling area close to the point of fill. Importantly, sampling plates can be replaced without opening machine doors, under laminar airflow conditions.

In all these respects, SYFPAC® DUO exceeds Annex 1 expectations for risk and knowledge management.

Mr. Consolaro commented:

“We were pleased to have this opportunity to reconnect with colleagues from across the BFS community at the BFS IOA Japanese meeting. It provided an excellent forum to contribute further to the collective knowledge of Blow-Fill-Seal technology and to introduce DUO and its remarkable capabilities to the Far East market.”

About Brevetti Angela

Brevetti Angela Srl is one of the world’s leading manufacturers of pharma primary packaging machinery, specializing in 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 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 product, 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 prefilled 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 and www.syfpac.com

About BFS IOA Asia/Pacific Meeting 2025

The Pharmaceutical Blow-Fill-Seal International Operators Association (BFS IOA) is an international industry association for pharmaceutical and associated companies with direct or indirect involvement with Blow-Fill-Seal (BFS) manufacturing. BFS IOA is a non-profit organization financed by subscription of more than 60 member companies worldwide and by sponsorships from the industry.

The association’s Asia/Pacific meeting for 2025 was a three-day event opening December 2 at the Hotel Metropolitan in Yamagata.

The event included one and a half days of technical presentations from Brevetti Angela and other leading manufacturers of BFS technology, as well as a tour of the nearby Nissin Pharmaceutical BFS facility.

The event was organised by the BFS International Operators Association with further information at: https://www.bfsioa.org/Events/AsiaPacific-meeting–Yamagata-Japan

Resources

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