Focus on qualification test sets
In the pharmaceutical industry, compliance with GMP (Good Manufacturing Practice) guidelines is not only a regulatory requirement, but also a decisive factor in ensuring product quality and patient safety. A central element of these guidelines is the comprehensive qualification of equipment, systems and processes used for the manufacture of medicinal products. This is where the importance [...]
Circular cleanroom garments-part of climate change control?
Since committing to Science Based Targets in September 2023, Elis has developed a roadmap to reduce our carbon footprint in multiple areas of the business. One of them is garment production, use, maintenance, and end-of-life processing, where there is potential for reducing CO2 emissions and waste. Working together on this topic can help reduce CO2 [...]
Measurement data acquisition and evaluation software
Modular software for measurement technology with over 35 years of market presence in many areas of industry. It supports different hardware from different manufacturers. The user-friendly interface is easy to use for the normal end user and makes the acquisition and analysis of measurement tasks effective. From small to extensive monitoring tasks, e.g. for the pharmaceutical industry, test benches, [...]
Special technical requirements for cleanrooms
Clean rooms are always required for the production of pharmaceuticals. The production of special drugs, such as radiopharmaceuticals, cytostatics or tablets with highly potent active ingredients, requires special environmental conditions. This presentation will focus on the technical implementation of the special requirements with regard to personnel and material flow - airlock concept, pressure cascades - positive and negative pressure and the associated zoning [...].
Best Practice - Cleanroom Monitoring System
We take you into the cleanrooms of a pharmaceutical manufacturer. We will show you what a cleanroom monitoring system can look like in practice. How was the measurement technology installed? We take a look at monitoring processes based on the technical and regulatory principles. For example, reporting, alerting or annual maintenance. What challenges did [...]
Digitization of construction supervision through robotics and AI
In this day and age, time is the most important commodity. That is why it is important to use digital means to save time. Monitoring construction progress with robots, camera technology and artificial intelligence offers this possibility. It makes the construction site accessible to employees at all times - even without traveling. For the use of robots and software, which [...]
Small batch filling - Efficient & flexible
In the pharmaceutical industry, the demand for flexible and versatile manufacturing processes has increased significantly to enable the production of different drug products. A flexible multi-product filling and capping line is an important component of this evolving landscape. This presentation will provide an overview of innovative multi-product filling and capping line solutions designed to increase efficiency and productivity [...]
VR training for cleanroom personnel
This presentation is dedicated to the complex challenges of pharmaceutical production, with a focus on quality, efficiency and sustainability. Particular attention will be paid to the indispensable role of well-trained operators. Rapid advances in the field of virtual reality (VR) are paving the way for new training methods. The immersion of operating personnel in virtual environments, especially for critical [...]
Automatic bio-decontamination - a "new" technology
Automated cleanroom bio-decontamination can be beneficial to pharmaceutical manufacturers as it reduces the risk of an unexpected contamination event, which can lead to time-consuming investigations, production downtime and sometimes batch loss. One of the reasons for updating Annex 1 was to promote advances in technology. Section 4.36 refers to the use of [...]
CCS Contamination Control Strategy
We show a successful and sensible adaptation of the hygiene regiment into a CCS according to the new Annex 1 of the GMP guidelines. We identify pitfalls and turn challenges into opportunities. Using practical examples, we show how the targeted use of disinfectants with different properties can improve the overall strategy, but also how problems can arise and [...].