Welcome to rommelag®
rommelag® is the inventor and master of the Blow/Fill/Seal (BFS) technology and market leader with a majority market share worldwide. Our special responsibility lies in developing guidelines for the solution of all our customers' requirements.
Our international customers' expanding requirements in the field of pharmaceuticals are continuously met by our newly developed strategies and our ongoing developments. Step by step development, starting with the design of packaging systems to the production of in-line equipment, which can be added to the bottelpack® machines, has made rommelag® the leading systems supplier in this field.
We are a highly competent system supplier, equipped with extensive know-how and ingenuity, capable to design and build according to your specifications and provide high level customer support and service.
In order to meet the different customers' requirements, rommelag® has developed an extensive bottelpack® machine program for bottle and ampoule manufacturing including machines with one mould, two moulds and 15 rotary moulds. Machine output is determined by shape and weight of the container, characteristics of fill product and plastic material.
bottelpack® Blow-Fill-Seal machines' basic design and the design of their subsystems undergo constant improvements. The result is operator-friendly equipment with lowest wear, highest process repeatability and reliability, thus meeting all current pharmaceutical regulations of the Health Authorities.
As the inventor of the Blow-Fill-Seal technology we have introduced technical milestones for this technology such as:
- Machine separation between filling and mechanical side (dark/white side technology) and bottelpack® aseptic design (CIP/SIP)
- class A (US-class 100) at point of fill
- up to 30’000 units/hour capacity
- volumes ranging from 0.1 mL to more than 1000 mL
- precision time-pressure-dosing
- electronic documentation system ROVIS
- FDA CFR21 Part11 compliant
- in-house container development, prototyping, and contract manufacturing
The Blow-Fill-Seal (BFS) Process
bottelpack® packaging systems are designed individually to meet specific customers' needs. BFS technology offers the huge benefit of enabling the entire process, which includes manufacturing a container, filling it with the product and then sealing it, to be completed in one short cycle using only one machine. Firstly, the sterile, pyrogen-free bottles or ampules are blow molded from extruded PE or PP in water-cooled molds. Immediately afterwards, the containers are filled with the sterile product in aseptic conditions and then hermetically sealed.
The process guarantees extremely high levels of reliability and product safety and also offers a number of other benefits for users. For example, molding the closure and applying a code can be integrated into the process. The key features of this technology are its almost complete exclusion of foreign particles and its neutrality towards the product in the containers.
Integration of bottelpack® Machine in the Manufacturing Process
bottelpack® Blow-Fill-Seal machines are usually placed where the filling machines of the conventional filling process had been installed. A typical Blow-Fill-Seal process is shown above. Following water preparation, product preparation and sterile filtration, the filling product is fed in sterile condition to the bottelpack® machine. The plastic granulate is transported from the resin material storage to the bottelpack® machine, is processed there to plastic packaging, filled with the filling product and sealed immediately.
Compared with the conventional filling process, the bottelpack® Blow-Fill-Seal process
- eliminates human intervention in the filling area by means of a highly automated work process.
- does not expose the liquid to a non-sterile environment and thus results in high sterility assurance levels.
- allows increased production efficiency through short set-up and preparation times.
- offers cost reduction potential by means of low space requirements, high degree of automation, cost effective package material.