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 [...]
Modular design frameworks in pharmaceutical production
In the increasingly demanding field of pharmaceutical manufacturing, the need for improved functionality, flexibility and compliance has never been greater. This presentation will focus on the implementation of modular design frameworks - for hardware and especially for software - as advanced control strategies to meet this need. A comprehensive description of these frameworks [...]
Cleanroom cleaning - new builds and conversions, what needs to be considered?
Every construction project is contaminated with dust and particles. These are undesirable in cleanrooms. We clean every cleanroom system so that it complies with the legal regulations of the respective RR class from day one, both in terms of particles and microbiology. Are you planning to convert your existing cleanroom facilities, do you want to expand your facility or are you a planner or cleanroom constructor? [...]
FacilityPro: A modern environmental monitoring system
Modern systems for environmental monitoring of cleanrooms and production facilities have become indispensable in pharmaceutical companies. They are a relatively simple tool for collecting and processing a wide range of data required for the release of a batch. The systems not only meet the data integrity requirements, but also provide additional [...]