Brevetti Angela aseptic pharma packaging

Brevetti Angela Srl is one of the world’s leading specialists in aseptic filling machine manufacture, particularly known for its advanced SYFPAC® range of solutions for Blow Fill Seal (BFS) aseptic parenteral packaging of sterile products such as pharmaceutical liquids and gels.

The company’s patented SYFPAC® machines enable high-speed sterile production of small volume (0.1ml to 20ml) parenteral plastic vials and ampoules, large volume (50ml to 1000ml) plastic bottles, or prefilled syringes in 0.5ml to 20ml sizes.

BFS aseptic packaging advantages

To meet the aseptic packaging definition, contents must be sterilized at high temperatures to remove hazardous bacteria and microorganisms before being inserted into sterile containers in a clean room environment.

Blow-Fill-Seal (BFS) aseptic packaging equipment has inherent advantages in that the sterile container does not have to come separately and to be previously sterilized. Instead, the container is formed, filled and sealed as an intrinsic part of one integrated aseptic packaging process inside a single container forming and aseptic filling machine.

SYFPAC is an acronym that stands for System for Filling Parenterals Aseptically into Containers. The system was inspired by founder Francesco Consolaro’s long-established expertise in plastic moldings and packaging. The system is based on BFS technology.

Using SYFPAC aseptic filling equipment confers several significant advantages for pharmaceutical parenteral packaging that include:

• Contamination free with no human interaction
• Free of particulates
• Cost effective manufacturing solution
• Greater ease in matching product to ideal primary packaging format
• Integrated aseptic filling
• Longer product shelf life
• Easier logistics in supply, transport and storage
• Highly scalable production, with the possibility to increase productivity by 60% on the same machine

The SYFPAC aseptic filling system is also particularly interesting in that it requires only a Class C standard clean room environment with limited dimensions (36m²) to accommodate a single compact footprint machine with no need for ancillary container storage, washing, or container sterilization installations. Along with ease of automation, this also reduces personnel headcount in the production area.

Aseptic process conditions are guaranteed by Grade A sterile air shower during the filling and sealing steps. All aseptic filling process media are handled through pre-sterilized pipes, valves and absolute filters to comply with FDA and EU GMP guidelines.

SYFPAC® machines incorporate SCADA, HMI and automated control systems that capture, record and monitor all changes made to the machine operation parameters, with data integrity to FDA 21 CFR part 11 standards where necessary. The system also stores all alarm conditions generated during all phases of machine operation; and performs CIP & SIP, drying, and filter integrity tests automatically, while also providing automatic advance notifications and recordings of preventive maintenance activities.

Clean In Place (CIP) and Sterilize in Place (SIP) processes are integrated and are automatically performed internally as standard and automated procedures.

SYFPAC® aseptic filling equipment

The Brevetti Angela SYFPAC portfolio includes four aseptic filling machines particularly applicable to pharma production and packaging:

• SYFPAC® SVP: for the primary aseptic filling of Small Volume Parenteral vials and ampoules with volumes from 0.1ml to 20ml for vaccines, injectable, ophthalmic applications, etc., at up to 16,000 units per hour
• SYFPAC® TWIN: double-decker BFS sterile filling and aseptic packaging of Small Volume parenteral 0.1ml to 20ml vials and ampoules at up to 27,000 units per hour: 60% increase in production capacity on same SVP footprint
• SYFPAC® LVP: for the primary aseptic packaging of Large Volume Parenterals in plastic bottles from 50ml to 1000ml for IV solutions, irrigation, saline and other applications at up to 2,750 units per hour
• SYFPAC® SECUREJECT®: for sterile product manufacturing of prefilled syringes PFS and injection devices using BFS technology at up to 8,400 units per hour. Prefilled syringes can be squeezable for single use, or standard with inserts, from 0.5ml to 20ml

These aseptic filling machines form the bases for complete aseptic filling lines when combined with MECAS cap assembling and cap sealing units, or with MASEP for separation of strips into single vials. The system can also be expanded with a MAVAC unit to automatically collect, grind, and shred plastic scrap produced by the SYFPAC® aseptic bottling process, reducing it to granules ready to be fed back into the process as aseptic packaging material.

Resources

Click on SYFPAC® from Brevetti Angela for details of whole product range.
Click on BFS Technology  for explanation of the Blow-Fill-Seal process.
Click on BFS Containers for full range of aseptic container options.
Click on SYFPAC Features for details of using system to create an advanced aseptic packaging process.
Click on SYFPAC Videos to watch SVP and LVP aseptic filling systems in action.