Single-Use Bag Filling - RoSS.FILL Base

Aseptic fillers are aseptic filling machines that are used in the pharma industry in order to maintain a sterile environment in the process of fluid management. They are made to prevent the processed drug products from being contaminated with germs while they fill them into sterilized containers before sealing these. 

With the aim to facilitate a secure, flexible and reliable filling process, Single Use Support has developed the RoSS.FILL platform, with single use filling machines both for lab and bulk scale production.

An aseptic bag is a germ-free container that is used within the supply chain of several drug products. Sufficiently sealed, aseptic bags like Single Use Support’s IRIS Single-use bioprocess containers are designed to prevent the products that are stored within them from being contaminated.

Aseptic bags undergo sterilization before they can be used; the four main ways to do so are:

• Sterilization by heating
• Sterilization by radiation
• Mechanical sterilization
• Chemical sterilization

Single use bag filtration is usually performed during the process of single use bag filling and is vital to guarantee product quality. It is carried out to remove impurities from the processed drug substances when they are filled into single use bags.

The aseptic area requires maintaining a sterile environment for drug materials all the way from the manufacturing site to the place of application. This implies the necessity of specialized equipment that accompany this complex process as soon as the drug product is sterilized, including aseptic filling machines and tubing, sterile containers and a sterile filling environment. 

Additionally, the containers have to be sufficiently sealed in order not prevent contamination along the supply chain of the drug product.

While describing something as septic implies that it is contaminated with germs and potentially harmful or – in the case of tissue – damaged, aseptic means the opposite, as a consequence of adding the prefix a. Aseptic is normally used to describe a process that is kept germ-free, and has a similar meaning as the word sterile; the latter, though, is most commonly used to describe a specific environment that is free of germs. Sterile, in contrast, refers to the absence of all microorganisms. Sterility is often achieved through sterilization with high-pressure steam, chemicals, or radiation. In this context.

An aseptic filling machine is part of the supply chain of various goods, including several drug products. It is designed to facilitate the filling of drug products into pre-sterilized containers, before these are sealed.

Considering the need for highest accuracy within this process, aseptic filling machines need to be extremely reliable; Single Use Support has therefore developed the RoSS.FILL platform with high quality aseptic filling machines for different fields of application.