Special metallic materials
Increasing demands on corrosion resistance are prompting the pharmaceutical and biotechnology markets to find new ways of selecting materials. But what makes these materials special materials? A brief introduction to materials science, the alloy components and their influence on the properties of the material should shed some light on the subject. What significance [...]
Factory planning and clean room
As part of the holistic development of processes and factories with interfaces to the cleanroom, factory and cleanroom planning is the link between the different areas and represents the interests of processes and logistics according to the principle of "form follows function". Particularly in the run-up to projects, the objectives and boundary conditions are often not yet known and must first be [...]
Debates in disinfectant coupon tests
This presentation covers current debates in the industry on testing disinfectants for coupons. PDA Technical Report No. 70 and USP 43 will be covered in relation to current disinfectant efficacy testing in the industry. Recent FDA warning letters and 483s will be covered that clarify regulatory expectations for efficacy testing [...]
Flexible production of pharmaceuticals in small quantities
The future will bring a larger number of active ingredients that need to be produced in smaller quantities down to the patient-specific quantity of 1, which must be efficiently produced and aseptically filled on an industrial scale. The improved and further developed version of a variably adaptable machine and isolation concept is presented here with examples and discussed using various processes
TOC measurement in pharmaceutical water
The presentation deals with the TOC measurement of pharmaceutical water. The general requirements for the measuring devices are discussed and the various measuring techniques in the field of online monitoring are presented.
Side effects for existing buildings
In connection with increasing requirements for pharmaceuticals and their production, the requirements for the buildings in which they are produced are also increasing. What to do when new requirements are placed on the existing building? Is it that simple? Where is the building permit and what does it say? What can you do within the framework of the existing [...]
Maintenance and energy management of mobile batch tanks
To plan production processes in such a way that maintenance work and energy loads can be optimally taken into account. At the same time, the high flexibility of the mobile plant components carries the risk of unplanned and unplanned failures. Containers expanded as virtual twins enable the intelligent processing of data from sensors. For example, preventive maintenance measures can be [...]
Life cycle management in plant service
Service and maintenance are not the end of the GMP consideration of the pharmaceutical water system, but the beginning of the operator's life cycle management. We discuss how risk analyses and the evaluation of critical influencing factors can be used to implement the safest possible plant operation and continuous availability.
claire® neo - safety cabinets for the laboratory of the future
Safety cabinets provide a highly clean, controlled working environment in which products can be examined, processed or manufactured virtually free of particulate contamination. They are therefore primarily used for the sterile preparation and testing of pharmaceuticals and for handling sensitive biological or genetically modified substances. As safety equipment, they also make a significant contribution [...]
Modular ATMP Production - Case Study Planning & Realization
Case study: Design and implementation of a new flexible (modular) ATMP production plant: A large German biotech company has expanded its CMO capacity for ATMPs and vaccines at its site in eastern Germany with a new, highly flexible biotech plant. The case study provides an overview of the project development from the initiation phase through the concept planning and further engineering phases, based on "almost [...]