The development of the pharmaceutical fermenter
The bioreactor has been around for as long as human society has used bioprocesses in the form of fermentation and cell culture to discover, improve and produce vital foods and medicines. Throughout its long history, the bioreactor has constantly evolved to meet the demands of new product applications that have emerged since the 1980s with the advent of [...]
Accredited calibration according to EN/ISO 17025
In recent years, the importance of an accredited calibration certificate in accordance with EN/ISO 17025 has increased significantly. Only this accredited calibration guarantees internationally comparable measurement results thanks to the seamless traceability chain to the basic SI units. As part of your quality/test equipment system, you can implement traceability to the basic SI units both internally and externally. As an independent Designated Institute (DI) and independent [...]
Measuring device development in accordance with FDA and GAMP regulations
The FDA "Process Validation" and ISPE GAMP "risk based approach to calibration" guidelines contain a series of regulations on process control and the calibration of measuring devices. Many of these rules can be taken into account during the development of a new measuring device so that it can be integrated much more easily into a regulated environment.
New Work - New Learning - New Technology
A detailed description of the presentation will be provided at a later date as soon as we have the details.
Aseptic filling - packaging and line design
In line with the trend towards smaller batches, increased use of bioproducts and patient-specific preparations as well as an expansion of the range of packaging materials (COP vials, syringes, cartridges for pens), there are a variety of different design options for a production line for aseptic filling. In addition to the choice of packaging material and the required line output, a decision regarding the cleaning process [...]
No time for downtime - level calibration without gauging
Calibrating the measurement technology used offers enormous advantages in terms of quality assurance, process reliability and compliance. However, calibration is often associated with a high expenditure of time and money as well as process downtimes. These points also come into play when calibrating fill levels. The gauging of a container often takes a lot of time and valuable [...]
Decontamination with hydrogen peroxide vapor
Surface sterilization is ensured by our own patented process with hydrogen peroxide liquid evaporation. Intended for the sterilization of internal surfaces of closed boxes (e.g. isolators and airlock cabins) and internal surfaces of rooms.
13 years of experience with BIM in planning
In 2005, Lorenz Consult's IT strategy for planning and processing included the following 3 areas:1. project data can be accessed by internal and external project members regardless of location. The data is only stored and backed up in one place.2. the currently different programs can be retrieved from a higher-level master program on a project-related basis and [...].
Contamination control can reduce the microbial risk
A contamination control strategy considers microbiological monitoring of assessed points as a fundamental aspect of managing risks associated with contamination. Testing for microbial contamination includes various methods, two of which are bioburden and bacterial endotoxin testing. These two quality control tests play a crucial role in sterile and aseptic processing by helping to identify potential contamination in products or a facility. The more dangerous the [...]
Fast, robust and effective H2O2 decontamination cycles
H2O2 decontamination is an established process in the pharmaceutical industry, yet there are many theoretical and practical points to consider. Some of them are well known and obvious, but are not yet taken into account in the design of modern isolators, others depend heavily on the knowledge, experience and practical skills of the team who carry out the qualification and [...]