Risk management and contamination control interface
The implementation of a contamination control strategy (CCS) in accordance with Annex 1 brings a number of benefits and requirements for the pharmaceutical industry. The strategy ensures stringent control over the entire manufacturing process, which leads to increased safety and quality of pharmaceutical products and defines clear requirements that meet regulatory standards. The requirement [...]
The insulator as a barrier technology
The assessment of isolators as a barrier technology in the context of Annex 1 depends on various factors, including the manufacturing method, product characteristics and specific process and transfer risks. The choice of barrier technology is a crucial step for pharmaceutical manufacturers to ensure the highest quality standards. Isolators, as an established barrier technology, provide a physical separation between the [...]
Current developments and innovations in cleanroom measurement technology
The qualification of cleanrooms and clean air systems includes the entire assessment process for compliance with the relevant normative requirements for the intended use of typical trades. A decisive component of this qualification process is the application of EN ISO 14644 and its harmonization - including the corresponding particulate limit values - with Annex 1 in the EU GMP [...].
GMP-compliant and efficient cleanroom measurement technology
The provisions for the qualification of cleanliness zones in the manufacture of sterile medicinal products are set out in the current Annex 1. A crucial part of this qualification process includes the application of the classification according to EN ISO 14644 in order to ensure that measurements are carried out in compliance with the standard. Particular attention is paid to the measures from the contamination control strategy. In order to meet the requirements of the Annex [...]
TDL (tunable diode laser) O2 analyzers in pharmaceutical processes
Industrial processes are usually multi-stage and require process analytical measurement technology to ensure the safety, efficiency and reliability of the processes. Among the various process analytical measurements (pH, conductivity, turbidity, etc.), the measurement and monitoring or control of oxygen also plays a central role in many pharmaceutical processes. Accurate and continuous measurement of the O2 concentration is essential in numerous manufacturing processes in [...]
Communication in a cleanroom environment
Cleanroom loudspeakers should be of extremely high quality and durability, absolutely maintenance-free, installable in various ways and encapsulated in order to exclude any contamination of the clean environments by the acoustic system and to withstand various pressure influences in cleanroom environments. A typical application in such an environment is gassing with H2O2 for disinfection. In this case it is of [...]
Ventilation technology + digitalization: future-proof solutions
What are the benefits of digitalization in technical building services? What effect does the integration of BIM have on the planning process for ventilation technology for clean rooms? What advantages does digitalization offer in the manufacture of ventilation and air-conditioning equipment and what new opportunities does this open up for the entire value creation process? This presentation will address these and other questions. [...]
LCA: Ecological footprint of ventilation and air-conditioning appliances
The presentation highlights the methodology for determining the ecological footprint of ventilation and air-conditioning appliances. Using the example of an air handling unit for a production and filling line for pharmaceutical products, it will be shown how intelligent technologies open up new perspectives in terms of sustainability. Study results from a life cycle assessment show that the utilization phase of these air handling units has an even greater influence on the overall efficiency [...].
Efficient inspection of industrial ventilation systems
The challenges, advantages and solutions of inspections using indoor drones will be presented and discussed.
Flow visualization: The impact of Annex 1
We explain the impact of the updated Annex 1 on flow visualization in cleanrooms. It explains how smoke studies should be correctly conducted, documented and integrated into a comprehensive contamination control strategy (CCS). Special attention is given to determining the frequency of such visualizations to meet GMP standards and ensure a safe, contamination-free environment. This content [...]