GMP Annex 1 - Cleanroom garments
- GMP Annex 1- GMP classifications in cleanroom garments Cleanroom eyewear study: - Importance for your GMP Annex 1 compliant processes- Aspects of sustainability- Results of our first validation study in cleanroom eyewear- Tested durability & quality
Production of toxic substances in the isolator
In biopharmaceutical manufacturing, the trend is towards the production of new oncology products such as ADCs (antibody drug conjugates) or in the field of regenerative medicine such as genes and immunotherapies. Most of these pharmaceutical products are combination products that also contain a highly active substance. These highly active substances require a new form of employee protection [...]
EMSuite® Monitoring Next Generation
Based on the latest software architecture from Ellab, the monitoring system opens up new possibilities in the areas of data acquisition, data display and data forwarding to other connected systems. The new smart sensors ensure the most effective calibration over the entire life cycle of the system. Thanks to the hot swap technology, sensors can be replaced in seconds during operation [...]
Clean room air conditioning and flow characteristics
The use of cleanroom technology and cleanroom air conditioning is subject to the requirements of personal protection and/or product protection against contamination and impurities. The primary objective is to control contamination at the point of use, or at the point of release in the opposite direction. To achieve reproducible quality with the help of contamination control, defined flow parameters must be set depending on the substances/materials used, the production facility [...]
Mobile preparation container as a virtual twin
Mobile preparation containers and system components are an integral part of highly flexible production processes in pharmaceutical production. For various reasons, complete virtual integration into existing MRP and process control systems has hardly been possible to date. The presentation shows an efficient and safe way to integrate new and existing mobile batching containers and thus achieve maximum production safety and conformity.
Cyclop A1: Extended clothing concept - Annex 1
Annex 1 Chapter 7.13 stipulates that the face should be covered and enclosed at all times to prevent the escape of droplets and particles. Foggy glasses, uncomfortable headgear, improper clothing,... these are just a few reasons that may lead the wearer to inadvertently or carelessly create a contamination risk in the aseptic environment. We address these critical [...]
Mobile reference measurement in the cleanroom vs. calibration (DAkkS)
It is often necessary to verify flow sensors installed in the cleanroom or in clean processes from time to time without dismantling them and removing them from the cleanroom. It is then particularly important that the counter-measurement is implemented using the identical measuring principle. There are now wireless options that enable the cleanroom operator to monitor the flow sensors used [...]
Integration of self-calibrating devices in existing systems
Modern measuring devices provide additional quality indicators about their own condition, which can be retrieved as a verification report or calibration certificate. In existing plants, however, the process control systems are often not able to process this data. Using the example of self-calibrating thermometers, it is shown how "heartbeat technology" can be integrated and used without having to re-validate the system [...].
cGMP process and plant planning
There are many unique considerations and features of CGMP facilities, such as containment and segregation strategies, GMP flows and cleanroom performance requirements. Some of these concepts may seem complex and challenging, but it's worth remembering that each concept is linked to ensuring product safety and purity. One of the most important aspects is the correct application [...]
Safe design of shear-sensitive sterile processes
The use of magnetic stirring systems in shear-sensitive sterile processes meets the highest demands in terms of safety and sterility as well as product quality. The magnetic coupling ensures that the container integrity is fully maintained - contamination of the cost-intensive media by penetrating contaminants can be ruled out. The use of stainless steels, such as 1.4435; 1.4539; 1.4539 or 2.4602 (the latter three are special alloys) and high-performance ceramic materials, such as [...]