Cleaning and disinfection in cleanrooms
There are various types of contamination in cleanrooms that need to be avoided. The presentation will define and describe the different types of contamination. In addition, the main source of all contamination - humans - will be discussed. Furthermore, rules of conduct that cleanroom personnel should observe in order to avoid contamination are described. Finally, [...]
Improving energy management
Legal requirements on the part of the EU, the issue of climate change, availability and, last but not least, cost-effectiveness are key factors in the pharmaceutical industry alongside purity, safety and hygiene. Some solutions, such as heat recovery in ventilation systems or the use of waste heat, have long been state of the art. Others, such as the generation of steam using heat pumps or the use of [...]
EMSuite® Monitoring Next Generation
The Ellab monitoring system is based on state-of-the-art software architecture and offers a flexible solution for data acquisition, report generation and visualization. It complies with FDA 21 CFR Part 11 regulations and is validated by Ellab in accordance with GAMP5. The EMS can be installed on almost any IT infrastructure. The Ellab Smart Sensors enable the most cost-effective calibrations and [...]
Planning process in cleanroom projects
The planning process for cleanroom projects usually follows a structured process that ensures that all relevant aspects are considered in order to design and construct a cleanroom according to the specific requirements. The presentation will focus on the steps that are typically part of the planning process. It will focus on the essential element of integration for the success of the project [...]
Assisted reproduction techniques - clean room in existing buildings
GMP and cleanrooms in the ART sector are gaining momentum and the authorities are increasingly scrutinizing the requirements of the regulations. IVF practices and centers are facing major challenges when the authorities suddenly appear on their doorstep. Is cleanroom technology in the ART sector bad per se or are there possibly good compromise solutions? Approaches also with regard to increased patient safety: Where are [...]
Employee qualification - opportunities and hurdles
Employee qualification is still a top finding in inspections. This presentation is not about the legal requirements and the structure of training courses, but about how employee qualification can be implemented sensibly and profitably as a GMP requirement in order to achieve a benefit for all parties involved. Qualified and motivated employees are the essential core of a [...]
The future of energy in the life sciences sector
Are you facing the task of decarbonizing your energy-related processes? This presentation deals with the current challenges of the energy transition and takes a look at the key framework conditions for developing and implementing a roadmap. Special attention will be paid to sustainable energy solutions that are specifically tailored to the needs of the pharmaceutical and life science industries. An opportunity for [...]
My cleanroom project - planning, construction and commissioning
As part of the holistic development of processes and factories, factory and cleanroom planning is the link between the various areas and represents the interests of processes and logistics according to the principle of "form follows function". Particularly in the run-up to projects, the objectives and boundary conditions are often not yet known and must first be worked out. The right [...]
Design of pressure & flow control valves, e.g. in loops
You can count on practical tips and application examples for the following areas: - Relationship between flow and pressure and their mutual influence WITHOUT mathematical formulas - Why and how flow and pressure valves work on the process side - What are the physical limits and restrictions? - Simply determine beforehand whether the valve generates noise emissions! You can expect [...]
Qualification with sense and understanding
Qualified equipment and process environments are a fundamental GMP requirement. How can you set up, carry out and document a qualification that not only satisfies the inspector and then collects dust in the archive, but also brings long-term benefits and makes sensible use of the resources required? What needs to be qualified and to what depth? And how do I deal with [...]?