Furnishing cleanrooms correctly: Material, surface & design
The planning and furnishing of cleanrooms and personnel airlocks requires a balance between diverse requirements and strict specifications. This presentation takes a practical look at the demands authorities and users place on materials and design and how these can be met in practice. The properties and possible applications of materials such as stainless steel, HPL and solid surface materials are discussed in detail [...].
Planning the perfect cleanroom airlock
Staff access influences work processes and cleanliness levels. Efficient and cleanroom-compatible clothing requires well thought-out planning and design. In addition to personnel routes, the supply of garment articles and their disposal must also be taken into account. Solutions that optimize throughput, incorporate future requirements and comply with current guidelines will be presented using examples implemented for customers from the pharmaceutical industry. Particular attention is paid to [...]
Risk Minimization in Sterile Test Isolators Through Automation
According to GMP Annex 1, a decontamination process is required that is automated, validated, and reliably controlled. This presentation demonstrates how such a process can be implemented in Steriltest isolators and how it affects risk assessment. If decontamination is fully automated, this step can be excluded from the risk analysis, thereby allowing the focus to shift to […]
Special features of microfibers in the cleanroom
Microfiber is particularly suitable for cleanroom cleaning due to its special properties in absorbing both lipophilic and hydrophilic soiling. As it leaves hardly any particles behind during the cleaning process, it is ideal for both particle-sensitive and germ-sensitive cleanrooms. It can also be used in a variety of ways, both in the form of wipes and as a [...]
Cleanroom personnel
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, [...]
Reduction of emissions of fluorinated greenhouse gases
The European F-Gas Regulation significantly tightens the requirements for handling fluorinated greenhouse gases and sets clear standards for climate protection. It regulates the entire life cycle of refrigerants—from use and system operation to recycling, as well as training and documentation. The key evaluation criterion is the global warming potential (GWP), which measures a substance’s climate impact relative to CO₂ […]
Mission cleanroom: danger comes not only from microorganisms
The qualification of cleanrooms is a complex mission in which the biggest challenges are not always microbial in nature. In large qualification projects, risks often arise from limited resources, lack of skilled personnel or rising costs. This presentation highlights the pitfalls beyond exceeding limits and shows how personnel and budget issues can have a decisive influence on project success. Using practical examples [...]
Operational readiness in the pharmaceutical industry
The aim is to highlight the relevance for both technical and operational functions and to illustrate how early, structured preparation during project execution can make a decisive contribution to significantly increasing speed, compliance and efficiency during the transition to GMP operations. The close integration of planning, role clarification, KPI definition and ownership ensures that all [...]
Taking air sampler validation to the next level
Reliable monitoring of airborne microbial contamination is critical to maintaining GMP-compliant cleanroom environments in pharmaceutical production. While EN ISO 14698 and EN 17141 provide the regulatory basis for validating the physical and biological collection performance of portable air samplers, these standards alone may not cover performance under real-world conditions and do not ensure the robustness of [...]