Communication in a cleanroom environment
Cleanroom communication in accordance with ISO 146441 and ISO-4628-1 & VDI 2083 Among all the diverse equipment and installations in cleanrooms, the loudspeaker area is a seemingly inconspicuous one. And yet there is hardly a cleanroom that can do without these small sound transmission boxes. This makes it all the more important for cleanroom planners and operators to ensure that the right product selection [...]
Success factors - planning & construction of ATMP production plants
Advanced therapy medicinal products (ATMPs) have emerged as pioneering treatment approaches for challenging and rare diseases, including cell therapies, gene editing technologies and mRNA therapeutics. Despite their revolutionary potential, these innovative medicines face significant manufacturing challenges, mainly due to high costs and regulatory concerns that limit patient access. This [...]
Guide to the optimization of oligonucleotide production
With the increasing demand for the production of oligonucleotides (oligos), ensuring efficient and compliant plant design is becoming increasingly important. This presentation will focus on key aspects of plant design for oligo production, focusing on the complex interplay of regulations, standards and key safety aspects in line with European requirements. The speaker will provide practical [...]
Where is the revolution in pharmaceutical automation?
There's no such thing: the pharmaceutical industry is always at the forefront - or so you might think! But does the demand for reliability mean that steam locomotives are often preferred to modern technology? The innovations in hardware, transmission technology and software not only offer innovative improvements at all levels of the automation pyramid, but could also [...]
Cleanliness is no coincidence: requirements for cleanrooms
In sensitive industries such as medicine, semiconductor and food production, purity is of crucial importance for the quality and safety of the products manufactured. An introduction to this topic requires a comprehensive look at the various aspects that characterize purity in these industries. First and foremost, it is important to understand that purity is not just a [...]
Digital sensors in cleanroom technology
In many areas of measurement and automation technology, there is an ongoing trend towards miniaturization and digitalization of sensor technology, including in cleanroom technology. This presentation first describes current requirements for cleanroom technology and derives future trends for the sensor technology used there. The focus here is on the question of how digital sensors can [...]
Sustainably safe air filtration
Room air supply in the life science industry can cause "biological contamination". In medical technology and pharmaceutical production areas, a great deal of effort is put into hygiene. Reducing the concentration of germs is particularly important in the life science industry. This is the only way to meet the justifiably high demands of EU GMP and FDA [...]
Traceable pharmaceutical calibration using the example of humidity
In modern manufacturing processes, there is a requirement to precisely monitor the ambient conditions during the manufacturing process and, if necessary, to control them within a bandwidth. Typical examples of such requirements are semiconductor production or medical technology manufacturing. In addition to the ambient temperature, the relative humidity is particularly important as "ambient conditions". In the manufacturing process itself, there is often a need to control the humidity of [...]
CIP systems - more than just a pump?
Everyone is talking about CIP. In our presentation, which is based on over 30 years of practical experience in the field of CIP/SIP/DIP, we want to convey the basics of this topic. We will explain the modular structure of such systems and what we believe needs to be considered when designing such systems. Using many practical examples, we would like to [...]
Safety through risk-based cytostatic removal
Cytostatic drugs, as the active ingredients in chemotherapy are also known, are often an important component in the treatment of cancer or tumors. Unfortunately, however, these are also highly potent drugs that do not stop at healthy organisms and can cause lasting damage to them. For this reason, great importance is attached to protecting people's health along the entire process chain [...].