Smart Lab Ecosystem: modular system for laboratories and cleanrooms
The Smart Lab Ecosystem was founded by Siemens AG, H. Lüdi + Co. AG and Inside Reality AG in order to better manage the complexity of the laboratory environment, significantly increase the flexibility of the infrastructure and minimize energy requirements. Various experts are creating a modular system kit consisting of proven and tested solutions. The digital planning [...]
Annex 1 contamination control strategy - one year later
Annex 1 requires that processes, equipment, facilities and manufacturing activities should be considered in accordance with the QRM principles. This is a proactive means of identifying risks and scientifically assessing the risks. This expectation requires the development of an effective contamination control strategy (CCS) based on a scientific assessment to understand the process. In the Annex [...]
Responsibility for sustainable product development
Plant engineering is undergoing a transition to sustainable engineering that emphasizes the integration of innovative solutions and standards. The focus is on redesigning cleanroom technology, which opens up fresh perspectives in planning. Central aspects are sustainable product development, re-use concepts and circular economy, complemented by the importance of standardization and process parameters. The CO2 equivalent is moving into the spotlight as an indicator for [...]
Determination of the bacterial count in pharmaceutical water in real time
The determination of the bacterial content in purified water and water for injection purposes was previously based almost exclusively on time-consuming laboratory tests based on cell cultures. However, plate counting, which has been practiced for over 130 years, is an estimation of bacteria with high variability. This is based on the visual counting of a colony of cells. The pharmaceutical industry estimates that over 80 % [...]
From the world of paper to digitalization in the GxP environment
The digital revolution has long since begun and the buzzwords artificial intelligence (AI) and big data are on everyone's lips. In the GxP regulatory environment, however, many companies are still at the beginning of their digital journey. The integration of artificial intelligence and big data not only opens up modernized workflows, but also advanced analytics, predictive analytics and data-driven [...]
Digital traceability matrix for efficient qualification
Nowadays, traceability matrices are used as an important tool for planning and tracking commissioning and qualification activities. However, simple software tools such as Excel are usually used for this purpose. On the one hand, this is very time-consuming and resource-intensive, and on the other hand, the data cannot be reused digitally. In order to meaningfully reduce the scope of commissioning and qualification tests in an engineering project [...]
Conductivity measurements according to USP and Ph. Eur.
Conductivity measurement has been a tried and tested electrochemical measurement method for many years and, after pH measurement, is the most frequently used in industrial measurement technology. It has been used in practice for over 100 years. Conductivity measurement is essential for monitoring the quality of water for pharmaceutical purposes. Inline measurements in real time provide constant information on conductivity and [...]
Technology transfer - Planning for success
Almost every pharmaceutical company is confronted with the issue of technology transfer sooner or later. Regardless of whether this involves products, processes or knowledge, the transfer from a company (sending unit) to the receiving unit must be traceable and controlled at all times. A large number of regulatory principles provide the framework and direction for this. [...]
Online TOC analysis according to USP and EP 2.2.44
The monograph "Water for Injection" (WFI) of the European Pharmacopoeia Ph. Eur. has been revised and no longer requires the production of WFI by distillation. WFI may now also be produced cold using alternative methods (reverse osmosis, electrodeionization). The advantages for operators of production, storage and distribution systems for pharmaceutical water are significantly lower operating costs. Cold production, [...]
Initial hygiene inspection according to VDI 6022 in cleanrooms
Ventilation and air conditioning systems are the basic prerequisite for the operation of a cleanroom. These must be professionally planned, built, maintained and inspected. Ventilation and air conditioning systems ensure that: - Only supply air with the desired air quality enters the room - The differential pressure to the neighboring rooms is maintained - The polluted room air is removed from the clean room - The employees are provided with [...]