New technologies to improve product quality
New technologies optimize product quality in pharmaceutical filling lines and ensure greater product safety and shorter time-to-market. The integration of sensors enables real-time monitoring of environmental conditions and prevents contamination risks. Robotics and automation streamline production processes, minimize human error and maximize precision in filling machines under isolator systems. Data management software optimizes quality control by analyzing [...]
Modular cleanroom automation as a full service
Using specific projects and technical examples, we present the possibilities and benefits of our services and proven solutions for the automation and digitalization of cleanrooms as a full-service partner. In order to consistently automate cleanrooms and integrate the current trends in digitalization, services in the area of planning and solutions for the various [...]
Qualification requirements: CSV of pharmaceutical plants
Modern pharmaceutical plants are usually complex computerized systems. The requirements of computer/software validation in the qualification of modern pharmaceutical systems therefore deserve special attention. Based on a real project for the qualification of a roller compactor, the presentation will show which specifications must be complied with in the GxP-regulated environment, how such a system qualification is carried out, which documents are necessary for this [...].
Temperature calibration: efficient and time-saving
The metrological terms in connection with temperature calibrators are explained. What do the terms stability, measured value tolerance of the test specimen, external reference and internal reference mean for a temperature calibrator? What does the linearization of a calibrator mean and how is it carried out by the manufacturer? - The applications in the pharmaceutical and cleanroom sector are explained using examples: Calibration of [...]
Annex 1 Review: Stopper Bowl Challenges
Annex 1 stipulates for aseptic processes that parts with indirect product contact surfaces must be sterilized. However, due to the current design of RABS or isolators, certain stopper trays are either fixed or extremely heavy, which would require significant redesign of existing lines. Therefore, a risk analysis is required to minimize the risk of contamination when preparing the plug trays for [...]
How good is your active microbial air sampler?
This presentation covers the most important aspects of microbial air sampling. It introduces the regulatory requirements, discusses sampling efficiency and the concept of isokinetic sampling. Relevant data will also be presented and analyzed, giving attendees practical insights to improve the performance of their air samplers. This presentation is ideal for anyone who [...]
Challenges mapping & qualification of refrigerators
Discover with us in an innovative and entertaining way the challenges of mapping and qualifying refrigerators as well as proven solutions! The following aspects will be highlighted in an interactive format consisting of a presentation and a moderated discussion round: Definition of mapping and qualification: clarification of basic terms to create a common understanding. Motivations for the implementation of mapping [...]
Cleaning validation in analytics
In order to ensure product and patient safety, impurities and cross-contamination must be excluded during the manufacture of pharmaceutical drugs and active ingredients. For this purpose, it is necessary to establish appropriate validated cleaning procedures for the removal of undesirable impurities and to prove this in the course of cleaning validation using various analytical methods. The presentation will cover the basics of cleaning validation and the [...]
Microbiological monitoring
Microbiological monitoring is of crucial importance to ensure the quality and safety of products in aseptic production. In the upcoming lecture, the basics and methods of microbiological monitoring will be discussed as well as modern methods for the identification of microorganisms such as MALDI-TOF and DNA sequencing. Furthermore, practical solutions will also be presented to detect potential contamination pathways and [...]
Elastomer-free solutions for sterile process engineering
Elastomer-free solutions for pipe connections and interfaces in sterile process engineering, also with regard to current legislation (e.g. PFAS) Elastomer-free solutions for pipe connections and interfaces in sterile process engineering offer, with regard to current and future legal requirements, possible solutions which have been tried and tested in use for many years and are currently being increasingly used. The [...]