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 [...]
Clean room and pass through decontamination
This seminar will cover a risk-based approach to decontaminating critical items in cleanrooms and RABS. Emphasis will be placed on the control of hard-to-kill fungal spores such as Aspergillus and Chaetomium as well as bacterial spores and viruses. Recent case studies in cell and gene therapy and compounding pharmacies will be discussed in relation to Pass-Thru-Decon. Published [...]
Measurement and control of H2O2 biodecontamination cycles
Vaporized hydrogen peroxide is an effective antimicrobial agent that also destroys fungal spores, bacterial endospores and viruses. While isolators prevent contamination, to maintain aseptic conditions, vH2O2 biodecontamination is performed on the interior surfaces of the isolator and the exposed exterior surfaces of the materials and equipment placed within. Understanding and controlling the process conditions at all stages of vH2O2 biodecontamination [...]
How much validation is necessary? 3 answers for 1 system
The field of software and computer validation has always evolved towards achieving the best quality with the least effort, mainly through risk assessment practices and the use of supplier quality activities. With the introduction of the new Computer Software Assurance (CSA) model as an option to replace the older Computer System Validation (CSV) model, we are at a [...]