Does your H₂O₂ lock meet the new requirements?
H₂O₂ airlocks are an essential component of modern cleanroom logistics and offer the highest level of safety for the decontamination of materials. They ensure that both large transport items and smaller material flows are decontaminated reliably, in a validated and reproducible manner. Through the targeted use of hydrogen peroxide, combined with innovative airflow systems and particle management, the risk of contamination along the entire supply chain is significantly reduced. […]
What has Annex 1 achieved – innovative isolator solutions
Isolators and barrier systems are key components of modern cleanroom technology and play a crucial role in the manufacture of cytostatic drugs, in sterility testing, and in containment applications. They provide maximum protection for personnel and products and ensure the highest quality through precise process control, validation, and automation. By reducing manual intervention, the risk of contamination is minimized, while the […]
UVC decontamination for cleanroom logistics in accordance with Annex 1
Hygiene safety in the cleanroom does not begin with production, but rather with the material flow. Clean, contamination-free materials are the foundation for safe production processes and the highest product quality. The presentation demonstrates how UVC decontamination is integrated as a key technology into Annex 1-compliant logistics processes—for maximum purity, reliable decontamination, and the best possible protection of products and personnel. Through the […]
Effect of storage conditions on biological indicators
The study examined how different storage conditions affect the quality of VPHP biological indicators (BIs). The focus was on the D-value and total kill parameters, which provide key insights into the performance and reliability of the BIs. The study included tests under both recommended and non-recommended storage conditions to assess potential effects on the resistance and functionality of the BIs […]
Sterility test isolator STISO
Flexible applications, such as fast and effective material transfer or a stable sterile test, accelerate your production and final inspection processes. Product, environmental and operator protection as well as a fast and reproducible decontamination process are important foundations for fast batch release in microbiology. Sterility test isolators from OPTIMA are manufactured in a cGMP-compliant design. The sterility test isolator - STISO® [...]
Comparison of Wired vs. Wireless Thermal Validation Processes
Thermal validation using a wired validation system has evolved over time and remains a proven solution for validating or qualifying processes in the pharmaceutical industry. However, the effort involved is considerable, and the wide range of applications, as well as the demands placed on the system and users, are constantly growing. Added to this are increasingly tight schedules and staff shortages. Meanwhile, […]
Advantages of WLAN for EMS in GMP/clean rooms
This session will begin with an overview of the EMS and its key functions in GMP environments, as well as the benefits such as 'all in one' and 'paperless'. We will explore the possibilities for sensor connectivity, with a focus on WiFi technology - showing how it enables a secure, scalable and real-time monitoring system. Learn how WiFi can make the [...]
Membrane-based WFI generation with temperature control - experience
Are you still producing WFI via distillation? Are you still wasting energy unnecessarily instead of recovering your waste heat? Then you’ll certainly be interested in our cutting-edge solution. Imagine that your membrane-based WFI generators feed into a common distribution loop and, as the water flows through heating, cooling, and energy recovery systems, WFI is made available at various temperature levels […]
Weighing of highly active substances in sterile production
Weighing of Highly Active Substances in Pharmaceutical Production: • Introduction by Bernhard Steidle and Dirk Collins • What Does “Highly Active” Mean? • What Do OEL/OEB/BIEL Stand For? • How Is the OEL Measured? Brief description of an SMEPAC test • Case study: Boehringer Ingelheim Biopharma Biberach • Process description • Special considerations for highly active substances. What needs to be considered during feeding, cleaning, […]
MTP-Standardized Automation for the Future of Manufacturing
The production of the future requires maximum flexibility: products have to be manufactured in ever shorter times and often in small batches. This means rapid adaptation, modular device integration and the shortest possible conversion times in order to avoid downtimes. RETEL Neuhausen AG uses a practical example to show how standardized, modular automation solutions can be implemented using MTP (Module Type Package) [...].