Higher mopology: wiping process scientifically analyzed
Experience a new dimension in cleaning technology with our intelligent mop holder (iWMH)! This advanced system has been specially developed to meet the growing demands of modern working environments, taking efficiency and quality to a new level. With clever functions, the iWMH supports the optimization of work processes and contributes to quality assurance. Find out [...]
Validation Next Generation: Ellab's E-Val™ Pro Plus
Stay at the cutting edge of technology! We will show you how the cable-connected E-Val Pro Plus system is revolutionizing validation in the pharmaceutical and biotech industries. Learn all about the latest key features and system highlights that redefine efficiency and precision. We will shed light on current challenges in the industry and show you how the E-Val Pro Plus [...]
Isolator pure2: The flexible tool for your processes
Dear Skan's pure2 isolator is the essence of an isolator, flexible to use in various applications such as sterility testing, Cell&Gene research and Fill&Finish but also for the production of cytostatics. Its compact design makes it suitable for laboratories, pharmacies, hospital pharmacies and small to medium-sized pharmaceutical production facilities. The pure2 is equipped with a Siemens-based control system that offers various [...]
Energy optimization in cleanroom operation - practical tests
Since the operation of cleanrooms and clean areas requires a high amount of energy due to the air flow and air conditioning, there may be potential for optimization in terms of energy consumption. In this presentation, examples from a test cleanroom at Testo Industrial Services GmbH will be used to show how an energy-saving measure can be evaluated on the basis of collected measurement data. In addition [...]
Risk minimization through an automated sterile test
According to GMP Annex 1, an automatic, validated and controlled decontamination process is required. This presentation will look at how this can be implemented for sterile test isolators and what influence it has on the risk analysis. By automating the decontamination process, it can be completely excluded from the risk analysis and the focus can therefore only be on the preparation, loading and [...]
Robotic solutions in aseptic production
Flexible aseptic pharmaceutical production of small quantities
ebeam: Annex 1 compliant transfer with surface sterilization
Due to the increasing demand for pre-sterilized RTU components such as syringes and vials, ebeam technology is used as a transfer technology with surface sterilization for the transfer of RTU in a Class A cleanroom such as an isolator. Annex 1 specifies that the transfer of devices and materials into and out of cleanrooms and critical areas is one of the greatest potential [...]
A new path to aseptic ATMP production
ATMP manufacturing is a process that requires aseptic manufacturing throughout to ensure patient safety. Today, the processes are mostly carried out in a cleanroom B environment using a mixture of open steps and closed equipment. The technology transfer of such processes can be a lengthy process, often requiring adjustments to the original manufacturing protocols [...].
Annex 1 Requirements for pharmaceutical isolators
Annex 1 of the EU Good Manufacturing Practice (GMP) guidelines sets out specific requirements for barrier systems that prevent contamination during the manufacture of medicinal products. It forms the basis for the Contamination Control Strategy (CCS) and Quality Risk Management (QRM), both of which are crucial for improving product quality and ensuring patient safety. [...]