Invisible Travelers: Challenges in Air Filtration
Zone 1: HVAC System, Filter Stages 1 & 2 – Pre-treatment stage of air conditioning: Coarse and fine filters remove dust, particles, and contaminants from the supply air to ensure a clean air supply for downstream areas. Zone 2: Cleanroom Airborne Particle Filtration High-efficiency air filtration using HEPA or ULPA filters, which remove even the smallest particles from the air to ensure cleanroom conditions in accordance with classification standards. Zone 3: […]
Invisible Travelers: Challenges in Air Filtration
Zone 1: HVAC System, Filter Stages 1 & 2 – Pre-treatment stage of air conditioning: Coarse and fine filters remove dust, particles, and contaminants from the supply air to ensure a clean air supply for downstream areas. Zone 2: Cleanroom Airborne Particle Filtration High-efficiency air filtration using HEPA or ULPA filters, which remove even the smallest particles from the air to ensure cleanroom conditions in accordance with classification standards. Zone 3: […]
Invisible Travelers: Challenges in Air Filtration
Zone 1: HVAC System, Filter Stages 1 & 2 – Pre-treatment stage of air conditioning: Coarse and fine filters remove dust, particles, and contaminants from the supply air to ensure a clean air supply for downstream areas. Zone 2: Cleanroom Airborne Particle Filtration High-efficiency air filtration using HEPA or ULPA filters, which remove even the smallest particles from the air to ensure cleanroom conditions in accordance with classification standards. Zone 3: […]
Appendix 1: Big Words, Small Media-Fill Deeds
The presentation “Annex 1: Big Words, Small Media Fill Actions” calls for a shift in thinking regarding media fill tests. Despite their central role, they often remain mere formalities rather than genuine demonstrations of the performance of sterile processes. The new Annex 1 offers the opportunity to use media fill strategically—as a tool for continuous learning and improvement. The presentation shows how companies can move beyond mere […]
Validation of Alternative Microbiological Methods
Alternative methods for microbiological monitoring offer significant advantages over conventional plate testing. However, none of these alternative methods have yet been validated for pharmaceutical water. In this presentation, we will walk you through all the procedures and steps required for successful validation. Once validated, alternative methods can be used not only for in-process control but also for quality control. This means […]
Validation of Alternative Microbiological Methods
First-Air in accordance with Annex 1
In pharmaceutical manufacturing, it is crucial that critical processes take place in an environment protected by clean (as free as possible from particles and microorganisms) and low-turbulence air. This reduces the risk of microorganisms or particles entering the product and causing contamination. Annex 1 of the EU GMP Guidelines also places a strong emphasis on the first-air principle and verification through […]
First-Air in accordance with Annex 1
In pharmaceutical manufacturing, it is crucial that critical processes take place in an environment protected by clean (as free as possible from particles and microorganisms) and low-turbulence air. This reduces the risk of microorganisms or particles entering the product and causing contamination. Annex 1 of the EU GMP Guidelines also places a strong emphasis on the first-air principle and verification through […]
First-Air in accordance with Annex 1
In pharmaceutical manufacturing, it is crucial that critical processes take place in an environment protected by clean (as free as possible from particles and microorganisms) and low-turbulence air. This reduces the risk of microorganisms or particles entering the product and causing contamination. Annex 1 of the EU GMP Guidelines also places a strong emphasis on the first-air principle and verification through […]
When Air Becomes Visible: Cleanroom Optimization with CFD
Undesirable flow patterns are often only detected during flow visualization on the finished clean air system. This can involve turbulence, reversal of direction, stagnant air and similar undesirable effects that can lead to contamination of the product. Optimizing an already installed clean air system at a later date often involves a lot of time and expense and, in the worst case, production downtime. [...]