Primary validation of an RMM
The key to using an RMM (Rapid Microbiological Method) to monitor pharmaceutical water production is validation. The AQU@Sense MB is the first commercially available device that has successfully undergone primary validation. This presentation summarizes the methods and results of the validation.
Risk analysis
What does a risk analysis for an aseptic packaging line look like? What is expected by the health authority, how do you meet the requirements? Which standards are considered and are relevant in a risk analysis for aseptic filling machinesWho should be in the team? When is the best time for a risk analysis and how long does it take? What does such a document [...]
Automation of packaging processes in the cleanroom
Packaging processes in the cleanroom must meet the specific cleanroom requirements.
Cleaning systems for infeed into the cleanroom
What are the current challenges when introducing production systems? This is linked to a solution approach of a modular method for cleanroom-compatible cleaning. And the validation of cleaning effectiveness with regard to particulate and film-chemical residues
Efficient electric steam generation with HT heat pumps
Electric steam generation works efficiently with heat pumps and vapor recompressors with steam temperatures from +120°C to +200°C. Depending on the heat source and steam temperatures, coefficients of performance of up to 3 can be achieved. This means that they are three times more efficient than steam generators with electric heating, and for particularly high efficiency, steam networks can also be set to lower temperature levels with pressure boosting stations or several [...]
BWT AQU@Sense MB: Fully automatic germ count measurement
Fast, accurate and validatable. The reliable differentiation between living and dead cells and their fragments allows new insights into the entire water treatment process. The AQU@Sense MB enables early detection of changes before problems arise as an important component of your contamination control strategy and risk management.
Simple, safe, efficient! New ways of calibration
This presentation will take a closer look at problems that occur during the regular calibration of differential pressure sensors. Among other things, the influences of the choice of location, installation situation, the nature of the pressure hoses used and the human component as well as the resulting potential sources of error will be discussed. In addition, a solution for eliminating potential sources of error is presented, which significantly simplifies calibration and also [...]
Flexible plastic packaging in the cleanroom
Cleanroom packaging as a quality determinant for all products that have to be manufactured in a cleanroom.
Automated systems for metrological services
In this presentation, approaches for the automation of highly manual metrological applications are presented (calibration, cleanroom-related measurements and mappings). Examples of corresponding system solutions will be examined and the respective advantages highlighted. The particular challenge of validating these systems and maintaining the validated status as well as corresponding solution proposals will be demonstrated using established systems.
Effective wiping cleaning
The selection and validation of cleanroom consumables such as HiTech cleaning wipes takes time and should therefore be well planned. In this overview lecture, we present the generally available product types. We explain simple measurement techniques and common test specifications (ISO, VDI, IEST) that you need for qualification. We also explain what information you need from the technical data sheets for [...]