Are there alternative barrier technologies besides insulators?
The choice between isolators and alternative barrier technologies in the context of Annex 1 depends on various factors, including the type of manufacturing, the product and the specific risks of the process. The choice proves to be a crucial step for pharmaceutical manufacturers to ensure the highest quality standards. Various factors play a central role in this decision. [...]
CCS: Annex 1 updates and warning letters from the FDA
This presentation will examine Annex I updates on cleaning, disinfection, airlock decontamination, drain cleaning, disinfectant validation and contamination controls. FDA warning letters and best practices will be discussed. Case studies of ineffective contamination control programs will be presented, providing insights for improvement. Attendees will receive a roadmap to improve their contamination control strategy and avoid regulatory allegations.
Flow measurement in cleanrooms: requirements and procedures
Directionally defined airflow in cleanrooms protects products from contamination and disruptive particles are safely removed. For this purpose, a uniform air flow from the ceiling to the floor is maintained in cleanrooms with high cleanliness classes. The monitoring range extends from 0.36 to 0.54 m/s flow velocity (EU GMP guidelines, Annex 1 in Class A). This measurement is carried out on the cleanroom side after terminal filters. [...]
Annex 1 from the perspective of the system manufacturer for RR technology
In the new Annex 1, there are a number of changes that must be observed especially for planners, installers and service providers of cleanrooms (room and airlock concepts and barrier systems) with regard to air routing, qualification and requalification. The changes in Annex 1 concern system technology (air conditioning technology), room planning (airlock concepts), the qualification and requalification of rooms to achieve and verify the [...]
Dehumidification in a clean environment
Air dehumidification in a clean environment, adsorption dehumidification, dehumidification through condensation, areas of application and limits of use The two common methods of air dehumidification in air conditioning technology are condensate dehumidification and adsorption dehumidification Which technology is used for air dehumidification to achieve the required climate parameters depends on various factors. There is no generally applicable basic rule. The basic parameters are the room temperature [...]
Reduce the cost of laundry processing to up to € 0
Companies with at least 20 employees are legally obliged to fill a certain number of their jobs with severely disabled employees. For every unfilled mandatory job, a so-called compensatory levy must be paid to the legislator every month. In short: the company pays a penalty on an ongoing basis. Get this money back from the state by awarding contracts to sheltered workshops. [...]
DECOpulse® - H2O2 bio-decontamination system
Next Generation H2O2 bio-decontamination - reliable process for highest operator and product safety. The H2O2 bio-decontamination system DECOpulse® enables robust and reliable decontamination with fast cycle times. High production times and high flexibility in pharmaceutical production are guaranteed by the fast cycle times. Due to the very low H2O2 consumption with savings of up to 65%, outgassing is very [...]
Innovative fusion: IoT & AI in life science buildings
Experience the key aspects of the Internet of Things (IoT), artificial intelligence (AI) and smart buildings in our presentation. The IoT is about the seamless networking of physical devices, enabled by sensor technology and connectivity, in order to collect and exchange data in real time. In the context of AI, it highlights how intelligent algorithms and [...]
Agile/Iterative method according to GAMP5 2nd Edition
In this presentation, the "Agile/Iterative Method according to GAMP5 2nd Edition" is explained in more detail. Here we deal with the question of how the development and implementation of AI/ML (Artificial Intelligence/Machine Learning) computerized systems could look like in a regulated environment. Using a concrete case study, we take you on a journey and explain the thought processes and the [...]
Sterility test isolator STISO
Flexible applications, such as fast and effective material transfer or a stable sterile test, accelerate your production and final inspection processes. Product, environmental and operator protection as well as a fast and reproducible decontamination process are important foundations for fast batch release in microbiology. Sterility test isolators from OPTIMA are manufactured in a cGMP-compliant design. The sterility test isolator - STISO® [...]