Process simulation in the pharmaceutical industry
Process simulation is used for the analysis and optimization of existing and/or new processes (greenfield / existing infrastructure) within the pharmaceutical industry. Various scenarios are simulated in order to investigate the effects of different conditions on processes, systems and production. With the help of process simulation, plants can be customized or planned based on customer-specific requirements. At the same time, the optimization [...]
EU GMP Annex 1 and its significance for ultra-pure media systems
In our presentation, we will examine the new requirements of Annex 1 with a focus on ultra-pure media systems and the potential impact the new revision is likely to have on operators and suppliers. The chapters and requirements relevant for high-purity media systems and the consequences derived from them from our point of view will be discussed. The main focus here is [...]
Membrane systems in pharmaceutical water treatment
This article takes a closer look at and compares the various membrane systems used in pharmaceutical water treatment. We would like to give you an overview of the different membrane technologies - what were the beginnings of membrane technology and where do we stand today? We look at the different design features of reverse osmosis membranes and compare the respective advantages and disadvantages. [...]
The "overlooked" Chapter 3 of the new Annex 1
An effective quality system forms the basis for the development of usable processes and suitable medicines. In this context, the key responsibilities of management, the competent person and quality assurance must be highlighted. By clarifying these roles, clear guidelines for effective implementation should be created. A particular focus is on the question of whether "quality oversight" in the [...]
Proven and new methods of decontamination
Disinfection, decontamination and sterilization are a matter of course in the medical and pharmaceutical environment. For decades, research was mainly concerned with the development of chemicals, substances and active ingredients. More recently, cleanroom technology has focused on application, measurement and simulation techniques. This presentation deals with different modern decontamination techniques and processes and shows alternatives to e.g. [...]
Room air technology: individual, hygienic and efficient
Ventilation and air conditioning units must ensure the quality of the treated air on a permanent basis. Individual ventilation and air conditioning units offer many advantages. Using examples, robatherm shows what individual solutions can look like and how they always meet the high requirements for hygiene and efficiency. robatherm's experience with air handling units for increased hygiene requirements is reflected in many details, [...]
Isolator design: individual vs. standard
The future lies in isolating entire production lines, production processes and critical work processes from environmental influences and integrating them into fully automated safety systems. Isolators and isolator technology can be divided into two categories: standard systems and individual user-specific systems. Based on technologies from the automotive and aviation industries, isolators are equipped with new measuring and monitoring technology. [...]
Fill & Finish - solutions to reduce interventions
Reducing glove interventions in a pharmaceutical containment system increases sterility assurance and minimizes contamination risks. This presentation highlights strategies to achieve these goals and emphasizes the importance of automation, advanced glove technology and stringent process controls. By implementing these measures, pharmaceutical processes can optimize efficiency, ensure product quality and meet regulatory standards within a contained environment [...].
O3 measurement in pharmaceutical water systems during cold sanitization
Ozone is a strong oxidizing agent that is able to kill microorganisms particularly effectively, thus making it possible to disinfect water safely and effectively. Ozone has been used to treat drinking water for over 130 years. Ozonization is an effective method with an increasing trend towards the sanitization of ultrapure water in pharmaceutical and semiconductor production as well as [...]
Cleanroom - Troubleshooting 4.0 in building technology
We want to show you the options for recording measurement data and storing it for carrying out fault analyses with historical data. The integration of conscious data collection makes fault analysis more complex on the one hand, but also clearer. Which systems will make our work easier in the future by collecting and processing all relevant data and then storing it in a [...]