South American Annex 1 and cGMP seminars in Colombia

Vicenza, Italy: – Leading manufacturer of high technology pharma packaging machinery, Brevetti Angela Srl will propose a series of seminars in Colombia dedicated to the Latin American market.

The events in Bogotá (July 8, 2025) and Cali (July 9) will focus on Annex 1 and GMP compliance and, being again in partnership with Bonfiglioli Engineering, they will follow a similar format to the recent highly successful Cairo Seminar for the Mideast and North African (MENA) market in Cairo.

BFS advances

The seminars are aimed at Latin American market professionals in Engineering, Quality, Validations, Development and Regulatory Affairs, with a program focusing on technological updates on compliance with Annex I and GMP that improve process efficiency and reduce risks.

They will feature an illustrated presentation from Brevetti Angela (English with simultaneous Spanish translation) that shows how its innovations in Blow-Fill-Seal (BFS) technology, especially in aseptic filling and particle control, now allow this highly efficient form of pharma primary and parenteral packaging to meet all EMA Annex 1 and cGMP standards.

In turn, Bonfiglioli will highlight the relevance of its advanced non-destructive inspection solutions to Annex 1 and GMP packaging container closure integrity testing (CCIT) and other Annex 1/cGMP packaging quality requirements.

Addressing South American market

The seminars are organised by the Bogota-based American Farma Group agency that has been since 1986 a solid provider of pharmaceutical machines and services. They will be hosted at the Hotel Wyndham Bogotá and Hotel Sonesta Cali, with each as a morning event from 0830 to 1200 hrs.

The seminars also offer Brevetti Angela an opportunity to introduce its revolutionary SYFPAC^® DUO BFS platform to the South American market, with its unparalleled scalability, compactness and flexibility.

Technical Sales expert Ajay Kabbur will present the DUO’s characteristics and advantages that include aseptic closed parison BFS combined with innovative insertion technology for prefilled syringes, vials, ampoules, eye drops, all small volume BFS containers from 0.2 to 50ml, along with its speed of up to 40,000 containers per hour.

He will also show how the modular form allows minimal demands on Class C cleanroom space, multiple layout configurations, the flexibility to work with multiple materials (LDPE, PP, HDPE) and easy scaling up to ten times baseline capacity.

His presentation will also emphasize the fully electric hygienic design of DUO, its ability to package temperature sensitive products, and its economy in reducing plastic scrap wastage to unprecedented low levels.

Meeting GMP and Annex 1 requirements

Fellow Technical Sales specialist Massimo Consolaro will then focus on how SYFPAC® DUO complies with Annex 1 requirements, by introducing particle monitoring within the closed parison, with both total and viable particles monitored real time during operation, which is a first and crucial development in a BFS system. This adds particular value to the fact that Blow Fill Seal is already intrinsically aseptic as it maintains fill and finish within totally contained aseptic Grade A conditions, and all process parameters are recorded and monitored by the machine SCADA system for regulatory validation.

Bonfiglioli’s presenter will be Technical Sales Manager and Sales Area Manager Gianmarco Pincelli who has recently held roles as an engineer specializing in pharma solutions and leader of the pharmaceutical applications team and design team. He is currently responsible for the technical training of the sales network and agencies worldwide, aiding personalized projects and liaising with industry standards bodies such as PDA, ISPE and BFS IOA.

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 Brevetti Angela SYFPAC^® DUO to learn more.
Click on Brevetti Angela SYFPAC solutions for Pharma for further information.
Click on American Farmagrup S.A.S. for further information.