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 [...].
Avoid false positive test results in the sterile test
Sterility testing is extremely important for pharmaceutical manufacturers as it confirms the sterility of the finished product that is released to the market for use by patients. However, false positive results can lead to delays in the release of products or even the loss of batches. We will explore the different approaches available for sterility testing and [...]
Disinfectant efficacy test
The validation of disinfectants has become the focus of pharmaceutical manufacturers at the latest with the new Annex 1 of the GMP guidelines. Can the data that disinfectant manufacturers have collected in order to register the products in the BPR (Biocidal Products Regulation) be helpful here? There are various EN standards for testing the effectiveness of disinfectants. How pharma-realistic are [...]
Innovations in further training for cleanroom personnel
People's changing learning patterns and needs due to the increasing use of media are shaping a new era of learning. Online learning and flexibility in terms of location, time and learning methods are becoming increasingly important. In this context, a paradigm shift has also taken place in the cleanroom sector, leading to new approaches in continuing education. The integration [...]
GMP-compliant and efficient cleanroom measurement technology
The current provisions for the qualification of cleanliness zones in the manufacture of sterile medicinal products are set out in the current Annex 1. A crucial part of this qualification process includes the application of the classification according to EN ISO 14644 in order to ensure that measurements are carried out in compliance with the standard. Particular attention is paid to the measures from the contamination control strategy. In order to meet the requirements of the [...]
Contamination control strategy - a holistic view
The implementation of a contamination control strategy in accordance with Annex 1 brings a variety of benefits for the pharmaceutical industry: The strategy ensures stringent control over the entire manufacturing process, which leads to increased safety and quality of pharmaceutical products and defines clear guidelines that meet regulatory standards. By implementing this strategy, companies can [...]