In 1963 Rommelag founder Gerhard Hansen invented and built his first blow-fill-seal machine. The technology was an immediate success. Only a short time later, in May 1964, he founded the Rommelag sales and marketing company in Aarau, Switzerland, in order to sell his products on the international market. Today Rommelag is a member of the Hansen Group headed by ceo Bernd Hansen, with sales companies in Switzerland, Germany, the USA and China. It is a leading supplier of blow-fill-seal machinery, Bottelpack.
Three steps
It’s a matter of three steps. All Bottelpack machines operate according to the blow-fill-seal principle (BFS). In a single automatic process they create containers from thermoplastic granules (blow), insert the contents (fill) and close them (seal). The technology has numerous advantages: the products contain no preservatives or contaminants; the process is fully automatic, which saves time, space and labour; the containers are sealed, unbreakable and collapsible; and maximum product safety is ensured at all times (the containers are aseptic and tamper-proof). Today these machines are used throughout the world in the pharmaceutical industry for aseptic packaging of sterile liquids, creams and ointments (including vaccines). New containers and closures are being created in a process of continuous innovation and optimisation. Examples are ready-to-use products like syringes with integrated injection needles, ampoules with a Luer fitting that does not require a harvesting needle, and unit-dose ampoules for eye drops, nose drops and ear drops with integrated dispensing chambers that eliminate the need for preservatives.
BFS technology does not require the cleaning and sterilisation processes that are essential in other kinds of container production. However, to ensure maximum safety in aseptic production, Bottelpack machines can be equipped with a range of safety, quality assurance and monitoring modules. In this way they comply with government standards such as those of the US Food and Drug Administration (FDA). The modules include aseptic systems for automatic cleaning and sterilisation of lines that come into contact with products. Other modules test containers for leaks, inspect them for particle contamination and automatically eject defective items. In addition, there are devices for testing ampoules during production, monitoring cleanroom air, etc. In spite of all these safety mechanisms, BFS systems can produce more than 34,000 containers per hour in sizes from 0.1 ml to more than 1,000 ml – impressive proof of their technological maturity and efficiency.
Customer contract
Rommelgag says close contacts with customers are a key to its success. The company coordinates the planning, commissioning and maintenance of its systems with each customer individually. Its worldwide services include deployment of specially trained service personnel, provision of remote diagnostics systems and customer training at the Bottelpack training Centre.
Glass is a key material. But customers throughout the world have recognised the advantages of plastic containers. Aseptic packaging by means of Bottelpac blow-fill-seal systems is gaining increasing dominance, says Rommelag. Modern plastics are strong enough to be made very thin without risk of breaking and they are easily collapsible so that ventilation is not necessary. They are chemically inert, free of additives and highly impervious to water vapour. Handling is easy and safe, not only in hospitals but also in mobile operations. This is why Bottelpack systems are coming into increasing use in countries where the healthcare system is still in development. Not surprisingly, China and India have become important markets for Rommelag.
Thanks to subcontracting by its sister companies Holopack in Germany and Maropack in Switzerland, Rommelag offers a range of products and services for packaging of liquids, including vaccines. It provides support to its customers in manufacturing trials, contract manufacturing, process development, qualification and validation. Customers can also move their Bottelpack machines to Holopack Pharma 2020 for production.