HEPA and AMC filtration for cleanrooms
HEPA and AMC filtration solve the challenges of contamination control in cleanrooms. They increase process efficiency and reduce energy consumption and carbon footprint (CFP). We will show you the next generation of HEPA and molecular filters and how they support you in meeting the requirements of the relevant standards (EN 1822, ISO 14644, ISO10121). We also look at the influences [...]
A case study on microbiological contamination incidents
This presentation will discuss a case study on a recurring microbiological contamination in the manufacturing process of a sterile drug product. Due to an incorrect identification of the contaminating microorganism, the source of the contamination could not originally be determined. CAPA measures were therefore taken, which were unable to prevent recurrence of the contamination. Only through the use of more accurate and [...]
Temperature monitoring in the cloud: advantages & things to consider
There are several aspects to consider when monitoring temperatures in the cloud. Firstly, your requirements for the cloud solution must be clearly defined. GxP compliance and security are particularly crucial here. The solution provider must ensure that all regulatory requirements are met in order to guarantee the integrity of the data. The cost of cloud versus on-premises data storage should [...]
Cold chain monitoring in rooms, appliances and transportation
Monitoring the cold chain plays a crucial role in proving the efficacy of a medicine and ensuring patient safety. The top priority is always to eliminate or at least minimize any risk to patients by strictly adhering to the manufacturer's specifications and the guidelines laid down by the various authorities. The monitoring of these conditions during the [...]
UV-C decontamination in cleanrooms: Binding application.
UV-C decontamination in cleanrooms: Applications. - Decontamination by UV-C radiation in classified areas. - Introduction to UV-C - The UV-C technologies - UV-C in cleanrooms and its applications - Integration of UV-C in cleanrooms, the methods - The keys to a successful UV-C project UV-C decontamination in cleanrooms. Implementation study and realization. The effectiveness of UV-C treatments [...]
Well lit, illuminated for a long time without contaminating
Well-lit, long-lasting illumination without contamination. - The keys to a successful Led lighting project in cleanrooms. - What are the main criteria for choosing the right cleanroom luminaires? - Adapting the luminaires to the duration of use and maintenance. - Adapt the luminaire to the structure of the cleanroom and its qualification. - Adapt the luminaire to [...]
Cleanroom covers - apparent safety and risks
Depending on the environmental conditions, airborne contamination is deposited over time in all areas. This also applies to controlled environmental conditions - such as in cleanrooms. Although the air in cleanrooms is filtered and monitored, contamination is still deposited on critical components, products and surfaces over time. It is therefore common practice to [...]
Acceptance criteria in medical technology
The presentation highlights the challenges involved in deriving acceptance criteria for the cleanliness of medical devices, particularly with regard to particle contamination, for which there are increasing requirements (e.g. from the Medical Device Directive, ISO 13485 etc.). However, there is usually a lack of concrete procedures and specifications for deriving limit values for the variety of medical devices. Therefore, one often resorts to [...]
Tests for cleaning in clean drying rooms
The production of battery cells is a central component of the ongoing electrification of vehicle drive systems. The use of clean and dry rooms in this production process is of crucial importance, as they provide a controlled environment that significantly influences the quality and performance of the battery cells produced. The use of a clean room alone does not guarantee contamination-free operation; it also requires the [...]
Mars Sample Curation Facility
What are the cleanliness aspects and requirements in the aerospace industry and why are these particularly important and can even become a danger if they are not complied with? Technical specifications in cleanroom technology, their effects and current trends in the aerospace industry are highlighted. Goals and solutions for a safe environment in space travel complete the topic around [...]