Supplier Qualification: Benefits, Risks, Solutions
At first glance, the idea of integrating supplier-provided training services seems appealing. However, in practice, it often turns out that the expected benefits fail to materialize due to shortcomings in implementation. It is essential to develop a sound approach and establish a clearly defined division of responsibilities in advance. Key factors here include the integration of operator requirements, structured communication, […]
Contamination Control: Digital Twin & 3D Simulation
Cleanroom operators face challenges such as high operating costs, unexpected downtime, and frequent delays in the launch of new pharmaceutical products or revised formulations. Building and verifying a digital twin of the infrastructure and conducting 3D simulations for particles, airflow, and energy help to create and restructure production and laboratory environments more quickly and cost-effectively. […]
AI in the GMP Environment – Case Study, Opportunities, and Risks
AI is rapidly taking over every sector of industry. However, particular caution is warranted when it comes to regulated industries. What requirements apply to the pharmaceutical and medical device sectors? This presentation provides an overview of the current regulatory framework as outlined in the EU AI Act, the EU MDR, and Annex 22. It critically examines whether AI can actually be considered […]
Cleanroom Technology in the Printed Circuit Board Industry
Following many rapid developments, the question of the right cleanroom concept remains a key focus. The goal is to protect production as effectively as possible, operate the facilities economically, and at the same time safeguard both personnel and the environment. While there are many new technical options available today, the biggest challenge remains: quality requirements are constantly rising, and the […]
Sustainability & Resilience: Digital Energy Efficiency
The demands for sustainability and resilience in industrial and building services environments are constantly increasing. This presentation highlights how digital solutions from Siemens play a key role in improving energy efficiency and ensuring operational reliability. The focus is on the use of digital twins, such as the “Basis” system, which enables the economic optimization of digital energy systems through the use of predictive data. […]
Cleaning Validation through Quality by Design
An engineering-based perspective on how Quality-by-Design (QbD) principles significantly support the development of modern cleaning technologies. The presentation highlighted the importance of a clearly defined User Requirement Specification (URS) as the foundation for effective communication between users and equipment suppliers. The adoption of a structured approach to cleaning strategy is no longer optional—it is crucial for ensuring compliance, […]
Fungicidal efficacy of alcohol-based disinfectants
Alcohols such as propan-2-ol or ethanol are frequently used in contamination control during pharmaceutical processes. Interestingly, products with identical formulations containing 70% (v/v) propan-2-ol may exhibit different levels of efficacy against fungi, i.e., levurocidal or fungicidal activity. The influence of the cultivation of A. brasiliensis specified in EN 1650 in 2013 was compared to earlier […]
Quick and Effortless Batch Record Review
Paper-based batch records are still commonly used in cleanrooms. This often leads to errors and omissions in manual entries, compromises data integrity, and forces reviewers to carefully examine dozens (or even hundreds) of pages to identify issues—instead of focusing on actual non-compliance cases or deviations in production activities. This results in […]
Having data integrity issues with your devices? We have the solution!
The workflows for measuring instruments continue to rely heavily on paper-based records, as metadata must be manually recorded on printed tickets, measurements must be transferred to lab logs, and the use and maintenance of the instruments must be documented separately. In addition, many devices do not print timestamps or other metadata, their date and time settings are not password-protected, and statistics on the number of measurements performed can […]
Annex 1 and the Sorting Bin Problem – New Feeding Systems
Annex 1 of the EU GMP guidelines presents the pharmaceutical industry with significant challenges—particularly with regard to ensuring sterility for components that come into indirect contact with the product. A key problem is the sterile introduction of large-volume sorting vessels into high-throughput systems. Conventional solutions such as the sorting vessel reach their limits here, as their geometry introduces complexity as well as a […]