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 […]
Reducing CO2 and energy consumption in HVAC systems
This presentation describes the growing importance of sustainability in the pharmaceutical industry. It begins with an analysis of energy consumption in HVAC systems at production facilities and then presents specific case studies and design principles. The presentation highlights several ways to reduce energy consumption and CO₂ emissions, including measurable upgrades. It also emphasizes how the design of HVAC systems can help stakeholders […]
Life cycle assessment in ventilation and air-conditioning technology
This presentation examines the methodology for determining the ecological footprint of HVAC systems. Using the example of an HVAC system for a pharmaceutical production and filling line, it demonstrates how smart technologies open up new avenues for greater sustainability. Findings from a life cycle assessment show that the operational phase of these HVAC systems has an even greater impact on overall efficiency than […]
How to Ensure Hygiene and Reduce Operating Costs
Air handling systems play a crucial role in maintaining cleanroom hygiene. This presentation demonstrates how careful planning and design enable air handling solutions that meet strict hygiene standards while operating efficiently—thereby providing clean air with minimal resource consumption.
Rethinking Learning: How to Build Lasting Skills
In the context of cleanrooms, employee training is a requirement under GMP regulations—but does it actually make a difference? In this presentation, we’ll explore how companies can design learning experiences that not only impart knowledge but also develop skills and ensure they’re actually applied in day-to-day work. The first part of the presentation will discuss modern learning architectures such as microlearning or […]
GMP non-compliance in the tension between quality, cost, and time
Based on many years of consulting experience, certain GMP issues frequently arise in the manufacture of healthcare products. These issues are examined in detail, along with proven countermeasures and ways to mitigate deficiencies. Underestimated GMP deficiencies can quickly become a threat to the very existence of companies in the GXP sector—but this does not have to be the case. At first glance, it is surprising that certain […]
Humidity as a Key Factor in Cleanrooms
Controlling humidity in cleanrooms is a key factor in ensuring stable production processes and compliance with quality standards. The presentation will explore the technical fundamentals of air humidification, typical challenges such as particle prevention and hygienic design, as well as integration into existing ventilation and HVAC systems. Using practical examples, various solution approaches will be presented that focus on energy efficiency, operational reliability, and standard-compliant design […]