SYFPAC® BFS aseptic packaging of parenterals and injectables in pharma and biopharma

Blow-Fill-Seal (BFS) technology has been used for the packaging of pharmaceutical products since the 1960s. BFS is different from traditional aseptic filling in that the whole parenteral packaging process is inherently contained and integrated within a single machine that forms the containers, fills and seals them.

Brevetti Angela Srl is one of the world’s leading manufacturers of pharma and medicine packaging machines, particularly known for its advanced SYFPAC® range of solutions for BFS aseptic parenteral packaging of sterile pharmaceutical liquids and gels.

The company’s patented SYFPAC® medicine packing machines enable high-speed 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.

Parenteral packing advantages 

SYFPAC was specifically designed for aseptic packaging of pharma parenteral products, as reflected in the system’s very name, which is a contraction of SYstem for Filling Parenterals Aseptically into Containers. The system is based on BFS technology in which the plastic container is formed, filled and sealed all within the same medicine packaging machine in one single integrated process.

Compared with traditional processes for packaging of parenterals in which preformed, usually glass, containers are presterilized, filled and sealed in different steps, and then terminally sterilized, the SYFPAC BFS system can offer significant savings in storage, time, and production footprint.

It is also inherently safer since traditional methods run higher risk of contamination in a process that is less contained, more distributed and involves greater human interaction. There are also handling and safety advantages in using plastic materials instead of glass, which involves less parenteral preparation.

The cost of production (COP) advantages tends to increase with scale, making BFS ideal for large production. However, the system also has inherent flexibility in handling different types of containers, since the SYFPAC design makes it fast and easy to change packaging formats by swapping molds within the machine or even change polymer for the same container.

Thus BFS is suitable for all types of large and small volume parenteral packaging, including bottles, ampoules, vials, and single use prefilled syringes.

The system is also ideal and highly cost effective in clean room environments from Class D up to Class C standards, being a single medicine packing machine with compact footprint (36m²) with no need for ancillary container storage, washing, or container sterilization installations. Along with ease of automation, this also reduces personnel headcount to Zero in certain cases in the production area for significant cost savings while reducing greatly the contamination chances.

SYFPAC® range

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

• SYFPAC® SVP: for the aseptic primary packaging of Small Volume Parenterals (vials and ampoules with volumes from 0.1ml to 20ml) for vaccines, injectables, ophthalmic applications, etc., at up to 16,000 units per hour.
• SYFPAC® TWIN: double-decker BFS aseptic primary packaging of SVPs at up to 27,000 units per hour for a 60% increase in production capacity on same machine footprint.
• SYFPAC® LVP: for the aseptic primary packaging of Large Volume Parenterals in plastic bottles from 50ml to 1000ml for Veterinarian Vaccines, IV, irrigation, saline and other applications at up to 2,700 units per hour.
• SYFPAC® SECUREJECT®: for 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.

Aseptic process conditions are guaranteed by Grade A sterile air shower during the filling, and sealing steps. All process media are handled through pre-sterilized pipes, valves and absolute filters in compliance with New ANNEX 1, 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.

SYFPAC BFS parenteral packing benefits

Blow Fill Seal aseptic packaging of parenterals and injectables using the SYFPAC system offers a range of user benefits over traditional aseptic filling methods, which include:

• Inherently aseptic and contained technology with no human interaction
• Contamination and particulate free
• Cost effective and highly automated manufacturing solution
• Entire process in one machine for reduced floorspace
• Highly scalable from niche batches to large volume manufacturing
• Improved sterility
• Variety of raw materials (PP, PE, HDPE)
• A throughout Sustainable Process
• No preformed containers and pre-sterilization necessary
• Flexibility in medicine packaging design and matching product to ideal parenteral packaging format
• Handles multiple parenteral dosage forms (same mould for different volumes)
• Reduced logistic costs in supply, transport and storage

For Pharma Applications the SYFPAC BFS process can create a variety of container shapes and sizes used for packaging sterile pharmaceutical liquids. These BFS containers can be suitable for unit dose applications, such as ophthalmic products, inhalation solutions and orally administered products. Alternatively, they can be used to produce sealed aseptic LVP or SVP containers, as part of the infusion or injectables manufacturing process.

In Biopharma manufacturing, BFS is becoming increasingly preferred for the packaging of respiratory and ophthalmic drugs, as well as for topical and oral administration products. In biopharma, the high assurance of asepticity and low load of viable and non-viable particles due to reduced human intervention, together with the possibility to safely fill thermolabile preparations, make BFS technology perfect for vaccines and other biological types of parenteral products.

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 package format options.