Aseptic Filling How Automation Helps to Enhance Aseptic Filling Processes
Aseptic filling processes for pharmaceutical liquids, lyophilised and biotech products must comply with strict hygienic conditions. The Macofar VF liquid fillers offer sterility assurance by their unique slim design. Manual interventions are restricted to a minimum during production. Product safety and ergonomic criteria are at the focus of this technology.
Pharmaceutical liquids, lyophilised products and the so-called red biotechnology are gaining more and more importance for medical treatment. Almost half of the pharmaceuticals that are currently undergoing licensing procedures around the world are biotech products. Experts are convinced that high-priced niche products will gradually conquer international markets.
The age of agent innovations, sold in large quantities, appears to be history. Great advances in gene technology in recent years have formed a basis for this development. Biopharmaceuticals are obtained from organic material of working animals, plants and micro-organisms.
Main Goal: Minimising the Particle Content
The greater part of biotech medicine is administered by injection instead of oral ingestion. The manufacture of these parenteral drugs is thus subject to the strict conditions of sterile production procedures. These obligatory standards are laid down in the Current Good Manufacturing Practices (CGMP) issued by the US Food and Drug Administration (FDA). The main goal is to minimise the particle content of the air during filling and closing operations. Particles can contaminate a product as well as act as a vehicle for harmful micro-organisms. This makes critical area control essential.
Phamceutical Filling - It's About Keeping the Microorganisms Out
In such a scenario, technical design of the filling equipment plays a vital role in keeping the concentration of harmful microorganisms in the machine’s processing area as low as possible. Macofar VF aseptic liquid filler is designed for such demanding situations. The distance between the filling nozzles and the front of the machine is less than 600 mm. The critical zone, the so called “white area”, through which the open containers are passed, is very narrow in order to assure an effective control of harmful germs.
This slim design supports the strict monitoring of the aseptic process and minimises the formation of particles.