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 [...]
Efficient project management in the GMP area of existing buildings
Efficient project management in the GMP area is essential for conversions and expansions in existing cleanrooms and in the GMP environment. Companies face numerous challenges, from complying with strict rules and regulations to minimizing business interruptions during the conversion. Ensuring continuous production and ensuring cleanroom classifications are key areas of responsibility. In this presentation [...]
PPT - Your partner in the field of Aseptic Engin. & Cleanroom
PPT - Pharma Process Technology - Your strong partner in the field of Aseptic Engineering & Cleanroom Processes PPT Pharma Process Technology GmbH is a service company consisting of specialists with many years of experience in the design, commissioning and operation of production facilities and production processes in the pharmaceutical industry. Our mission is to be a reliable partner for the pharmaceutical and [...]
Qualification of the asep. core zone - Flow visualization
Qualification of the aseptic core zone - flow visualization For a successful qualification of an aseptic core zone, a wide variety of points must be examined. A flow visualization, also known as a smoke study, is a crucial part of this qualification to understand the flow patterns in isolators, RABS systems and cleanrooms. It allows potential contamination or leaks to be identified and rectified. For visualization [...]
How to design energy-optimized WFI systems
Planning WFI (water for injection) systems is a complex and demanding task that has to take many factors into account. Since 2017, the production of WFI using membrane technology, known as "cold" WFI production, has also been approved in Europe. Since then, there have been further options for the design of the generation plant and distribution systems when planning WFI systems. A [...]
Use case: Customized cleanroom monitoring system
In this presentation we give an insight into the successful realization of a GMP cleanroom monitoring system. This innovative project was carried out in collaboration with our valued application partner, Solupharm Pharmazeutische Erzeugnisse GmbH. In this presentation, we will explore the key aspects of the project, starting with an introduction of our partner, followed by a discussion of the customized user requirements that defined the [...]
Mobile particle monitoring: digital instead of gluing & signing
Discontinuous particle monitoring for GMP cleanroom classes B, C and D is usually carried out sporadically and is a very labor-intensive and time-consuming activity that quickly results in several hundred measurements per month and a correspondingly large amount of working time. For many cleanroom operators, the operational processes have been carried out in the same, unchanged way for decades: [...]
CO2 emissions in the production of pharmaceutical water
Water for injection (WFI) is an important tool in pharmaceutical production. Nevertheless, together with HVAC, WFI is responsible for the largest share of greenhouse gas emissions in the pharmaceutical industry. This is due to the fact that WFI is still predominantly generated by the energy-intensive process of distillation, which is powered by plant steam. The plant steam, in turn, is [...]