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 [...]
Risk minimization through correct glove management
Gloves are currently still the most proven option for manipulation within isolators, barriers and other systems. However, they also pose the greatest risk to the integrity of these applications. Incorrect handling, poor maintenance or inadequate monitoring can result in leaks through which bacteria and germs can enter. It is therefore important to have a suitable glove management program [...]
Stumbling blocks and milestones: Implementation of ISO14644 Part 9
ISO 14644-9 deals with particle contamination on surfaces. It provides limit values, so-called SCP classes, for particle concentrations on walls, floors, work areas and products, for example. It also provides information on testing and test reports. However, there is also a lot that is not considered. In this presentation, we want to take a closer look at this part of ISO 14644 as well as related [...]
Case study: Detailed life cycle analysis (LCA)
WFI production by distillationEnergy-intensive distillation has long been the standard method of choice for the production of water for injection (WFI) in pharmaceutical GMP production. However, the increasing importance of sustainability in pharmaceutical operations and the current turmoil in the energy markets are challenging the status of this method. Many companies are now considering switching to [...]
Filtration technologies for pharmaceutical processes
In the presentation we will discuss contamination control in pharmaceutical cleanrooms. We will highlight the challenges in the different process steps regarding HEPA filtration. Process safety and risk management are the key success factors for efficient processes and product reliability. Product contamination is not only very expensive for the pharmaceutical industry, but also leads to image damage and / or in the worst case [...]
Microbiological monitoring
Microbiological monitoring is one of the key elements of an effective hygiene concept in aseptic production. The current methods for microbiological monitoring and the identification of microorganisms will be explained in more detail during the presentation. In addition, possible courses of action will be outlined on the basis of the available identification results and other methods that can be used to trace contamination paths will be presented.