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Optima Presents Solutions for Small Batches and Flexible Filling at Achema 2018

May 29, 2018
Pharmaceutical Technology Editors

Optima will also display the freeze dryer CS and the sterility test isolator STISO at the show.

The requirements of the pharmaceutical industry are shifting toward smaller batch sizes and flexible filling equipment and processes. With the MultiUse platform, Optima Pharma offers a concept for pharmaceutical companies to handle small batch sizes and diverse container types. Optima Pharma also introduces comprehensive scientific process engineering (CSPE)-a process that generates a timeline from the order to start of production that is safe and efficient. Optima Pharma will also display the freeze dryer CS and the sterility test isolator STISOat Achema 2018.

Flexible machinery for small batch sizes and diverse container types

Niche products require a completely different production process compared with blockbuster pharmaceuticals. Pharmaceutical companies that produce small quantities of highly specialized products need flexible machines that can process small batch sizes and different container types while at the same time, maintaining product quality and patient safety. Optima Pharma’s MultiUse platform, a preview of this technology will be presented at Achema (Frankfurt, June 11–15, 2018). The MultiUse machines are designed to process different primary packaging materials-from vials and syringes to cartridges. These machines have minimum space requirement, according to Optima, because the basic machine does not have to be exchanged. A variety of technologies minimize product loss such as re-dosing upon request, short hose lines, 100%-in-process-control for vials, syringes, and cartridges, weigh-dosing, re-capping upon request, and much more.

Current developments for sterile filling

The needs of the pharmaceutical and biotech users are changing. The decision about a specific machine configuration is made later and later in the project process. In order to react to these changes Optima Pharma developed the CSPE-process, which will be introduced at Achema. The combination of scientific methods and technological processes makes the time from the order to the production start safe and as short as possible. For example, simulations to recognize and avoid the problem zones of the laminar flow are already present during the design phase. Vaporized hydrogen peroxide (VHP) decontamination can also be simulated, to reveal, at an early stage, if all surfaces inside the machine are decontaminated. Simulation also reduces development time tremendously.

A freeze dryer for small and medium size batches

The freeze dryer CS from Optima Pharma is customized for products that are new to the market and are produced in small and medium sized batches. The freeze dryer CS is designed to be installed into existing buildings and can be flexibly configured for an optimized overall layout. It comes in a compact design and can be installed as a monobloc or dual bloc. 

New standards in isolator technology

The sterility test isolator STISO from Metall+Plastic, a subsidiary of Optima, is setting a new standard in isolator technology, according to the company. The STISO is used for aseptic and aseptic-toxic products. Advantages include a well-designed operator ergonomic concept, full flexibility due to its modular design, fast installation, as well as a glove testing system integrated in the human machine interface (HMI). Due to the catalytic conversion and the DECOjet technology, the STISO achieves short cycle times during the contamination. Because of the hydrogen peroxide flash evaporation, the STISO has low maintenance. Optima will also be displaying a decontamination system that is even faster than the established DECOjet, the DECOpulse system. This system creates less droplets than typical dispersion systems. 

Optima will also showcase other expertise such as laser cutting and individual dosing; digital solutions to support operators and help avoid damage to machinery; and its lifecycle management system known as “Optimal Total Care,” which includes services for each phase of the machine lifecycle and maximizes the possibilities of digitalization. 

Source: Optima, Hall 3, Booth A73