Contamination Control Strategy is easier than you think
A comprehensive and overarching CCS - this has been a regulatory requirement since last year. Establishing a contamination control strategy in your own company may seem like an impossible task at first glance. This is not least due to a lack of guidelines for implementation. What is the CCS? What are its contents? And how do you succeed [...]
Contamination Control Strategy is easier than you think
A comprehensive and overarching CCS - this has been a regulatory requirement since last year. Establishing a contamination control strategy in your own company may seem like an impossible task at first glance. This is not least due to a lack of guidelines for implementation. What is the CCS? What are its contents? And how do you succeed [...]
Contamination Control Strategy is easier than you think
A comprehensive and overarching CCS - this has been a regulatory requirement since last year. Establishing a contamination control strategy in your own company may seem like an impossible task at first glance. This is not least due to a lack of guidelines for implementation. What is the CCS? What are its contents? And how do you succeed [...]
Operational readiness of aseptic manufacturing areas
Operational readiness is a critical process in the pharmaceutical industry, especially when commissioning new or remodeled aseptic manufacturing areas. This presentation will highlight the key aspects of operational readiness and its importance for efficient and safe production. Operational readiness encompasses the management of all activities necessary for production readiness. This begins with the start of an investment project and [...]
Innovative TOC design prevents unnoticed downtimes
Swan Analytical Instruments AG has optimized the handling and overall performance of online TOC monitoring through incremental, continuous improvements over the years. This presentation will highlight the latest advancements. Significant advances in calibration and fluidics have significantly reduced the total cost of ownership for end users. TOC is an essential component in the monitoring of ultrapure water and [...]
Automation of QC sampling: from the GMP cleanroom to the QC lab
JAG demonstrates how these end-to-end QC processes can now be fully automated, digitized and tracked in real time, from the classified zone product container to the QC lab bench, using state-of-the-art, TRANSVERSE INTEGRATION of mobile robotics, process technology, S88 formulation sampling plan and QC data throughout the cleanroom, building, equipment, lab and product release documentation.
Laboratory automation/robotics in safety cabinets/isolators
Customized special safety cabinets in combination with laboratory automation offer efficient and safe solutions for a wide range of laboratory applications such as bioreactors, Facs devices and liquid handling systems, which must take place in a BSL-2 environment due to increased safety requirements. The safety cabinets, designed in accordance with DIN EN 12469, enable aseptic working under GMP-A conditions and guarantee the necessary personal, product and environmental protection. Aseptic industrial robots can also be used in [...]
Energy management as a success factor in the energy transition
Energy management plays a crucial role in the energy transition, as it can significantly improve the efficiency and operation of systems. By taking targeted measures to optimize energy efficiency, companies can not only reduce their operating costs, but also make a significant contribution to reducing greenhouse gas emissions. This is particularly relevant for the cleanroom industry, where precise and [...]
AMC the 3rd source of contamination in cleanroom production
Airborne molecular contaminants have been affecting cleanroom production for many years and pose a considerable challenge. Specific examples from the pharmaceutical industry, the chip industry and glass production will be used to shed light on this problem in order to provide participants with a better understanding. The various groups of substances that can jeopardize cleanroom processes will be presented in detail and their [...]
Introduction of sterile packaging for sterilization
AM presents a case study dealing with the optimization of sterilization processes in autoclaves to fully comply with the requirements of Annex 1. The main challenge for the customer is the packaging of machine parts to avoid the risk of contamination, tears and perforations as well as moisture after the sterilization cycle. Introduction: How AM works with [...]