Cleanroom Design and Construction – Avoiding the 10 Most Common Mistakes
The planning and construction of cleanrooms can be compared to the construction of a house: the matter is technically more complex than you might think, as there are a large number of interfaces to consider, the client often only does this once in a lifetime and does not have the technical expertise and: what is not considered beforehand costs [...].
From Theory to Practice – PUPSIT Valve Solutions from GEMÜ
Since the entry into force of Annex 1 to the GMP guidelines, PUPSIT (Pre-Use Post-Sterilization Integrity Test) has increasingly become a focal point in pharmaceutical production processes. The integrity test before and after sterilization presents operators and plant manufacturers with new technical and regulatory challenges: How can the necessary components be integrated into existing or new plants in a way that is safe, validatable, and space-saving? […]
The digitization request process is becoming more efficient and faster
Digitalization is fundamentally transforming the pharmaceutical industry—from development to plant design. Our company aims to actively shape this transformation and create measurable added value throughout the entire product lifecycle. A key component of GEMÜ’s approach is the digitalization of technical specification sheets. Instead of paper-based documents, we use structured digital data models that are consistent across departments […]
Maintenance Tailored to Requirements in Existing Facilities
Digital Maintenance Reimagined – with CONEXO, GEMÜ, and Thomas Rücker (Pharmaceutical Water Expert) In this practical presentation, GEMÜ and pharmaceutical water expert Thomas Rücker demonstrate how digital maintenance can be implemented easily, efficiently, and without a major project using CONEXO. Instead of complex IT infrastructure or months-long implementation, the focus is on intuitive use: CONEXO offers an innovative solution that […]
From Distillation to Ultrafiltration – Converting WFI Production
This presentation addresses the cost-effective retrofitting of existing distillation systems to modern membrane systems for WFI production. It focuses on technical and economic aspects using practical examples, including cost savings, payback periods, and various concepts for producing cold and hot WFI. The goal is to highlight ways to achieve greater efficiency, sustainability, and cost-effectiveness in pharmaceutical water treatment. Nick Eilenberger, Product Manager […]
Project Approach with Technology Transfer in the Pharmaceutical and Biotech API Sector
The pharmaceutical and biotech industry is constantly developing new drugs, medical devices, and dietary supplements and bringing them to market. Demand for such new products often arises in countries that are not part of the primary business focus of the manufacturers developing them. Glatt Ingenieurtechnik frequently receives inquiries regarding the design and construction of production facilities for such new products. In such cases, […]
Analysis of the Current and Future Applications of VRF and FFU in Modular Systems
The challenges of cleanroom construction involving complex HVAC systems have always been significant, particularly when it comes to overlapping and complicated ductwork systems as well as heavy and large air handling units. In response, Airkey has introduced a modular cleanroom system with VRF air conditioning that optimally addresses these issues. First of all, the modular cleanrooms are prefabricated at the factory, enabling IKEA-style assembly and a quick […]
CFD for the Optimization of Aseptic Processes
The presentation demonstrates how simulation supports both regulatory compliance and engineering development in the design of cleanrooms and isolators. It explains how flow modeling contributes to quality assurance in accordance with Annex 1 and ISO 14644, and how CFD simulations of decontamination can be used to assess homogeneity and identify potential problem areas or hotspots. […]
Appendix 1: Insulator Specifications – What Regulatory Authorities Expect
This presentation highlights the current regulatory requirements for isolator systems as outlined in Annex 1 of the EU GMP guidelines. The focus is on regulatory expectations regarding the entire lifecycle of an isolator—from planning through qualification and validation to routine operation. Key topics covered include containment concepts, aseptic process control, environmental monitoring, decontamination strategies, and requirements for material and personnel flows […]
Redefinition of material transfer in accordance with Annex 1
In response to the revised Annex 1 of the EU GMP, which introduces stricter requirements for contamination control and aseptic processing, a leading pharmaceutical manufacturer faced the urgent challenge of modernizing its packaging processes to ensure regulatory compliance and maintain sterility assurance. The greatest difficulty lay in integrating the various machine operations within sterile production environments to […]