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High-tech methods for sterile processing

26th August 2019


Aseptic processing is required at the highest level for new types of biopharmaceutical drugs and biosimilars, as is a high degree of flexibility. Optima Pharma's Optima MultiUse Filler perfectly satisfies these requirements for filling and capping, as well as in other related processes. As well as this, the company's Optima H6-10 is a flexible, high-performance system. The modular construction of the Stiso sterility test isolator from Metall+Plastic also tests and safeguards the aseptic condition of the processed drugs. At CIPM, Optima Pharma will also be giving information on the filling of hyaluronic acid in pre-filled syringes. 

At CIPM using the tagline "Smart Solutions for Pharma Experts", Optima Pharma will be presenting the latest machine technologies such as the MultiUse Filler. This type of machine is particularly suitable for efficiently and safely processing small to medium-sized batches and highly potent medicines. Vials, pre-filled syringes and cartridges can be processed without the need for format parts as a result of the flexible machine platform and the robot technology used. The MultiUse systems have already been designed for the use of isolators and for connecting freeze drying systems. 

The H6-10 has been designed for high performance and flexibility. This type of machine is particularly suitable for nested pre-filled syringes. For example, its versatility is demonstrated by the various filling systems available, including rotary piston pumps, peristaltic pumps and time-pressure filling. An in-process control (IPC) can also be integrated for maximum filling accuracy. Its wide range of other options means that the system can be perfectly adapted to meet user requirements. It has a capacity of up to 36,000 containers an hour. 

The Stiso sterility test isolator from Metall+Plastic is setting new standarda. It offers extremely short decontamination cycle times and - together with the low-maintenance H2O2flash evaporation - particularly high levels of machine availability. When it comes to operation, the ergonomic design and a number of details such as the glove test that can be carried out via the HMI are particularly impressive. It has a modular construction and can be flexibly adapted to meet specific customer requirements. Two versions are available, for aseptic or aseptic high-potency applications. 

Vacuum filling with no bubbles
Hyaluronic acid products have a range of applications, ranging from the treatment of arthritis to cosmetic treatments in the form of fillers for the skin. Because of what is sometimes a very high level of viscosity, precise filling of pre-filled syringes requires specific rotary metering pumps. To ensure that syringes are completely bubble-free – a particularly important quality criterion - filling and sealing processes are carried out under vacuum. Optima Pharma can successfully meet these demands thanks to the SV125 machine. 

Optima experts from Germany and China will be available at CIPM to answer questions about these and many other types of machinery.





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