A quick guide to Blow-Fill-Seal (BFS) Aseptic Filling Technology

What are the pharmaceutical applications of BFS technology?

Blow-Fill-Seal technology was invented in 1962 by Rommelag founder Gerhard Hansen. BFS technology is a pharmaceutical primary packaging-filling process that combines three normally separate operations: container formation, filling and closure/sealing. 

It is the consolidation of an automated form, fill and seal packaging sequence into one machine. Plastic containers are blow-moulded from extruded thermoplastic parison, filled with liquid product (gels, emulsions, suspensions) and sealed in one continuous, integrated and automated operation under aseptic processing conditions. There are many applications with a primary focus on the liquid pharmaceutical market for many routes of administration: parenterals (large and small volume), inhaled, oral, sub-cutaneous and ophthalmic. It can therefore also be used for vaccines and biologicals.

What are the benefits and opportunities that BFS technology can provide?

BFS is a rapid, flexible and cost-effective aseptic fill/finish solution for packaging sterile liquids for pharmaceutical applications. The container itself is newly created, and so eliminates the need for prior transportation and storage. It is break-proof, user friendly and offers flexibility for the design of the container. The exposure time is reduced from minutes to seconds, and the product is sealed immediately after filling. The risk of contamination lessens with each of these steps within the single automated system compared to multiple ones. It is more accurate (less product waste) and reliable, and is approved by regulatory bodies in the EU (EMA) and the U.S.A (FDA). In fact, the inherent safety of the process, packaging sterile products under aseptic automated conditions has led the FDA to describe Blow-Fill-Seal technology as an "advanced aseptic process", (USP 1116).

Who invented the process? 

Rommelag is both the inventor and current global market leader for blow-fill-seal technology. Rommelag specialises in the aseptic filling of liquid drug products for the pharmaceutical and medical device industry with over 2000 bottelpack machines installed and operating in 80 countries around the world.

Rommelag Engineering division designs and builds bottelpack machines, which are capable of manufacturing up to 34,000 containers per hour in a wide variety of forms (examples include bottles/tubes /ampoules) and plastic blends (typically polyethylene or polypropylene) with filling volumes ranging from 0.04 to 10,000 ml.

Rommelag CMO division fills more than 2 million containers per day for customers all over the world, operating more than 50 systems in multiple configurations. Equipment and process are set up to meet EU/FDA pharmaceutical standards, perform test fills, and deliver production or small-scale batches for our customers.

Fill Finish Technology

We partner with Rommelag in the UK and Ireland to provide a range of equipment and outsourced aseptic filling solutions to our pharmaceutical, biopharmaceutical, biotech, and medical devices clients. As an equipment engineering services provider to the life sciences manufacturing sector, we pride ourselves in supporting our clients in the delivery of the design, build, CQV and operational phases of GMP manufacturing, with focus on sterile processing solutions.