We recently held a webinar on Blow-Fill-Seal (BFS) Aseptic Filling Technology in association with Rommelag, and we discussed the pharmaceutical applications of BFS technology, contract manufacturing options, and the benefits and opportunities that BFS technology can provide. 

Blow-Fill-Seal technology was invented in 1962 by Rommelag founder Gerhard Hansen. BFS is a rapid, flexible and cost-effective aseptic fill/finish solution for packaging sterile liquids for pharmaceutical applications. 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.

BFS technology is a pharmaceutical primary packaging-filling process that combines three normally separate operations: container formation, filling and closure/sealing. It is simply the consolidation of an automated form, fill and seal packaging sequence into one machine. Plastic containers are blow-moulded, filled with liquid product (gels, emulsions, suspensions) and sealed in one continuous 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.

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.  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).

ABOUT TEAM HORIZON

Team Horizon is a leading provider of technical, engineering and talent solutions to the Life Sciences sector. Founded in 2010, the company offers specialist project engineering solutions for the fill-finish, primary, secondary and tertiary packaging elements of the manufacturing life cycle, and contract services providing resourcing and recruitment solutions focused on engineering, quality, technical and scientific roles.

Team Horizon is the UK and Ireland agent for Rommelag, and offer considerable experience and expertise in project delivery, focusing on aseptic fill/finish applications including BFS technology. Team Horizon can provide support with equipment systems including formulation; aseptic filling and isolator systems; lyophilization; cleaning and sterilisation systems through to clean utility systems.

Clients include 15 of the top 30 global medical device firms, 16 of the top 30 global pharmaceutical firms and five of the top ten global biotechnology firms.

ABOUT ROMMELAG

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.