Employee qualification - opportunities and hurdles
Employee qualification is still a top finding in inspections. This presentation is not about the legal requirements and the structure of training courses, but about how employee qualification can be implemented sensibly and profitably as a GMP requirement in order to achieve a benefit for all parties involved. Qualified and motivated employees are the essential core of a [...]
The future of energy in the life sciences sector
Are you facing the task of decarbonizing your energy-related processes? This presentation deals with the current challenges of the energy transition and takes a look at the key framework conditions for developing and implementing a roadmap. Special attention will be paid to sustainable energy solutions that are specifically tailored to the needs of the pharmaceutical and life science industries. An opportunity for [...]
My cleanroom project - planning, construction and commissioning
As part of the holistic development of processes and factories, factory and cleanroom planning is the link between the various 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 worked out. The right [...]
Design of pressure & flow control valves, e.g. in loops
You can count on practical tips and application examples for the following areas: - Relationship between flow and pressure and their mutual influence WITHOUT mathematical formulas - Why and how flow and pressure valves work on the process side - What are the physical limits and restrictions? - Simply determine beforehand whether the valve generates noise emissions! You can expect [...]
Qualification with sense and understanding
Qualified equipment and process environments are a fundamental GMP requirement. How can you set up, carry out and document a qualification that not only satisfies the inspector and then collects dust in the archive, but also brings long-term benefits and makes sensible use of the resources required? What needs to be qualified and to what depth? And how do I deal with [...]?
Practical tips for modern aseptic sampling
PRACTICAL TIPS FOR MODERN SAMPLING VALVES AND SYSTEMS And how to avoid costly mistakes, e.g. correct and incorrect installation position or cleaning sequence or avoiding flaming or unfavorable insulation on the tank. Find out in this presentation how this conventional component has been completely rethought and optimized. You will also receive practical tips for correct installation and modern [...]
GMP meets Quality Culture
Implementing GMP regulations and ensuring GMP compliance are challenges that every company in a GMP-regulated environment must face. In addition to the appropriate and precise application of technical and organizational solutions, the sustainable assurance of GMP compliance of the entire organization can only succeed in close cooperation with the implementers, the employees. In addition to the technical and organizational solution strategies [...]
Sustainability in single-use manufacturing: HOF FTU Air-Line
The HOF Freeze-Thaw Units are used in the pharmaceutical and biotechnology industry for the controlled freezing and thawing of single-use bag systems. Previously, a synthetic refrigerant was used for this purpose. The new Air-Line of the HOF FTUs is now based on the use of only air as a refrigerant and therefore not only increases the performance of the system, but also [...]
Case study: Handling API and ADC in a Lyo line
The development and production of highly effective active pharmaceutical ingredients (APIs) and antibody drug conjugates (ADCs), a relatively new class of cancer therapies, places high demands on production facilities and operator safety. In the case study, the requirements for the freeze-drying plant and the associated loading and unloading system are discussed on the one hand, and the tried-and-tested implementation is shown and presented in detail.
Automatic opening/emptying of frozen plasma cylinders
The HOF Debottling Systems were developed to thaw frozen plasma bottles automatically and very precisely in order to be able to remove the remaining ice core with the surrounding liquid from the bottle easily and without any problems after cutting. With this system, HOF is once again providing a system that is technologically highly innovative. At the same time, this solution proves to be [...]