Digitally optimized qualification of calibration devices
GxP-compliant monitoring systems need to be calibrated regularly, not only because of regulations, but also to maintain accuracy and traceability. In a digital world, M2M communication helps to improve processes, reduce effort and increase data integrity. In the presentation, the digitally optimized qualification of a calibration system for temperature and humidity, as a method to [...]
Lean qualification: a smart approach to the qualification process
The presentation "Lean Qualification: The smart approach to qualification and validation of hardware in cleanrooms" offers an insight into the efficient planning and implementation of qualification processes for hardware in cleanrooms. The focus will be on the lean approach in order to make the qualification process lean and effective at the same time. The presentation begins with a comprehensive explanation of terms and definitions, [...]
Ceiling air circulation systems. Findings from a CFD simulation
Since turbulent cleanrooms have found their way into pharmaceutical companies, there have been differing opinions and, to this day, lively discussions as to whether the classic approach of floor-level return air extraction can be replaced by extraction via the ceiling without negative effects on the quality of the cleanroom. In our presentation, we will look at the two approaches and [...]
More sustainability for textiles in the cleanroom
The responsibility of companies to contribute to a safer and more sustainable future has never been greater. This responsibility is also evident in the cleanroom industry, which is characterized by high international requirements. In addition to safety and quality factors, sustainability plays a decisive role in the selection of textiles for cleanrooms. But how can we [...]
PETEK clean room technology in the injection molding sector
PETEK manufactures customized cleanroom solutions. During the presentation, PETEK will present customer-specific solutions using illustrative examples. With over 40 years of experience in the cleanroom segment, PETEK has a broad product portfolio and extensive expertise. PETEK cleanrooms and cleanroom equipment are used and highly valued worldwide. Both in the ISO and GMP sectors. Our customers come from [...]
CRB's innovative engineering, architecture, construction and consulting services
Expect a vivid presentation introducing you to the dynamic world of CRB, your leading partner for the design and construction of pharmaceutical plants in the life science industry. Learn how CRB is revolutionizing the industry with innovative solutions, cutting-edge technology and a clear commitment to excellence. From concept development to implementation, CRB guarantees smooth [...]
ATEX Zone 1 and 2 in the area of the containment isolators
The requirements for personal protection with regard to isolator technology are currently at the forefront of process technology. All the more so in projects for isolators, where ATEX zones are clearly defined according to an explosion protection document. Without a doubt, Zone 1 in the interior and exterior of an isolator poses a challenge, making the whole project extremely complicated. However, there is always a [...]
Handling of OEB 6 substances in isolators with SMEPAC Test
The handling of OEB 6 substances requires a very extreme and high level of safety in order to protect employees, the product and the production environment. Today, the process is usually carried out in an isolator, which ensures a safe environment. Currently, a tested SMEPAC method is recognized; a method that measures the concentration of particles [...]
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 [...]