An ISOLATOR is a barrier system well defined (physical) that can be validated to provide significant risk reduction of bio-contamination. An isolator provides an uncompromised, continuos, Grade A isolation of its interior from the surrounding environment.
A RABS is a combination of physical and aerodynamic barriers over the aseptic process zone. RABS is an alternative contamination control methodology designed to be used in a higher classification cleanroom (EU Grade B – ISO 7 minimum) and based on systems of less engineering complexity.
Elimination of infection is the goal of asepsis. The particular needs of working in aseptic conditions require special attention to achieve optimal integration between the inside and outside of the isolator. Comecer aseptic isolators have been designed to provide a safe and clean environment with superior sterility compared to other isolators or glove boxes. Comecer containment isolators, developed for the processing of highly toxic compounds, have been installed in leading pharmaceutical companies around the world. Our wide range combines proven design, devices and components that create unique solutions to fit our customer’s specific needs. Always focused on ergonomic results, any kind of compound can potentially be treated, from Highly potent powder, viscous fluids, creams, etc.
Given the complete separation between the operators and the aseptic area, the isolator solutions are more likely implemented together with a certain level of automation when the batch sizes are significant. Also when the API has to some extent containment need, the solution with an isolator is a must. On a the other hand RABS can be adopted when an extremely manual operation is carried out and no issue of containment is involved.
Comecer’s skill set in the aseptic and containment processes together with its ability to design customized filling and assembly solutions is the perfect partner where the product (liquid and/or powder) needs to be handled. In this sense, its wide experience includes platform for IV-Bags, Double Chamber Bags, Bags and Vial systems, Dual Chamber Syringe, Dry Powder Inhalers and others.
Solutions in aseptic micro dispensing of liquid and powder are implemented using partners or proprietary technology. A preliminary performance test study is carried out before selecting the final solution.
Among the technologies available: micro-auger systems, servo driven micro pipetting, custom design volumetric pumps, etc.
A preliminary feasibility study involves capacity definition of the line based on the complexity of the handling as well as expected throughput of the line. Compact systems to be repeated (scaled out) may represent the best fit to simplify development and validation activities.
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