Annex 1-compliant trending in cleanroom monitoring
Because GMP requires not only individual measurement values but also continuous evidence that a cleanroom is under control, Annex 1 mandates trend analyses. Basic Principle: Annex 1 aims to detect contamination at an early stage and to permanently minimize the risk of contamination for sterile products. Individual measurement points (e.g., daily values) are not sufficient for this purpose, as gradual deterioration, seasonal effects […]
Residues of Disinfectants in Cleanrooms – Management
This presentation examines the nature, risks, and control of disinfectant residues in cleanroom environments, with a focus on regulatory requirements, microbiological effects, and validated risk mitigation strategies. 1. Nature and Risks of Disinfectant Residues Disinfectant residues are non-volatile substances that remain on surfaces after application, with the exception of alcohols and hydrogen peroxide, which are virtually residue-free. Residues arise […]
BECKER QUICK OUT Airlock – Safe and Fast Airlocking
After sterile production, materials are typically transferred from GMP Class B to C, from C to D, and then from D to CNC/E. This process is time-consuming and labor-intensive. In this demonstration, you will see a material transfer chamber that allows you to transfer materials directly from GMP Class B to CNC/E in a single step and […]
BECKER QUICK OUT Airlock – Safe and Fast Airlocking
After sterile production, materials are typically transferred from GMP Class B to C, from C to D, and then from D to CNC/E. This process is time-consuming and labor-intensive. In this demonstration, you will see a material transfer chamber that allows you to transfer materials directly from GMP Class B to CNC/E in a single step and […]
BECKER QUICK OUT Airlock – Safe and Fast Airlocking
After sterile production, materials are typically transferred from GMP Class B to C, from C to D, and then from D to CNC/E. This process is time-consuming and labor-intensive. In this demonstration, you will see a material transfer chamber that allows you to transfer materials directly from GMP Class B to CNC/E in a single step and […]
BECKER QUICK OUT Airlock – Safe and Fast Airlocking
After sterile production, materials are typically transferred from GMP Class B to C, from C to D, and then from D to CNC/E. This process is time-consuming and labor-intensive. In this demonstration, you will see a material transfer chamber that allows you to transfer materials directly from GMP Class B to CNC/E in a single step and […]
BECKER QUICK OUT Airlock – Safe and Fast Airlocking
After sterile production, materials are typically transferred from GMP Class B to C, from C to D, and then from D to CNC/E. This process is time-consuming and labor-intensive. In this demonstration, you will see a material transfer chamber that allows you to transfer materials directly from GMP Class B to CNC/E in a single step and […]
BECKER QUICK OUT Airlock – Safe and Fast Airlocking
After sterile production, materials are typically transferred from GMP Class B to C, from C to D, and then from D to CNC/E. This process is time-consuming and labor-intensive. In this demonstration, you will see a material transfer chamber that allows you to transfer materials directly from GMP Class B to CNC/E in a single step and […]
Current developments and innovations in cleanroom measurement technology
Two methods are available for conducting standard-compliant leak testing of installed HEPA filter systems in accordance with EN ISO 14644, each of which meets different requirements in terms of operating conditions, accuracy, and reliability: the determination of mass concentration using an aerosol photometer, or the measurement of particle count using a scattered-light single-particle counter. Both leak tests assess the integrity of the filter medium and the correct installation of the entire filter system. To distinguish between the different classes of biological […]
AI Compliance in the Pharmaceutical Industry: Integrating the AI Regulation and GMP
Building on a structured overview of the provisions of the European AI Regulation, this section first explores key aspects in greater depth: the role and risk-based classification of AI systems, including high-risk AI, as well as the resulting obligations. These include, in particular, requirements for a quality management system, data and model governance, technical documentation, transparency, human oversight, robustness, and monitoring throughout the entire […]