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 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.

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.

Sterile filling is a process carried out in a sterile environment, where a sterile drug product is transferred into equally sterile containers. The process is performed when contamination of drug products with germs is to be avoided, and involves dedicated filling solutions.

Aseptic filling in the (bio)pharma industry describes a process performed to prevent a drug product from contamination on its way from the manufacturer to its application. By the means of specialized filling systems, the products are filled in sterile containers without being exposed to germs like bacteria. Since the entire filling process is kept aseptic, final sterilization is not necessary.

While describing something assepticimplies that it is contaminated with germs and potentially harmful or – in the case of tissue – damaged,asepticmeans the opposite, as a consequence of adding the prefixa.Asepticis normally used to describe a process that is kept germ-free, and has a similar meaning as the wordsterile; 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.

In the field of germ-free processes, there are various terms that seem similar but have a slightly different meaning to them. This also applies to the wordsasepticandantiseptic; whileantisepticis used when talking about making an environment free of germs,asepticrefers to keeping it this way.

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

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.

Single Use Support’s filling and draining system functions as a highly professional liquid sampling system for drug products – be it on lab scale or on bulk scale. It can either fill liquids in bags, bottles or vials at a high accuracy, with controlled pressure. Furthermore, an integrated sensor allows airless filling, optionally including the integrated filtration of your product.

The single-use bioprocess containers are well protected by the RoSS.SHELL system, allowing for plate freezing to be performed right after the filling process.

The liquid path of the biologics is fully disposable – from the sterile connectors to tubing –, which saves costs and resources.

Bulk drugs, also known as active pharmaceutical ingredients (API), are ingredients of drug products that are inserted in order to have a biological impact on the person it is administered to.