Advanced aseptic processing
What is aseptic processing for liquid products? Why: Accelerated by the new Annex1, the demand for isolator applications is increasing. How is a production isolator characterized? Design of the machine Choice of materials Bio-decontamination process Air treatment How is an aseptic production isolator operated in a liquid product filling line? What are the typical steps between two production batches. Examples from the [...]
Aesthetics in industrial construction - technology is only half the battle
"Increase performance and well-being with cleanroom aesthetics" Companies have been focusing on the aesthetics of their buildings for some time now. This has proven to be an effective way of increasing not only the well-being but also the performance of employees. An attractive workplace design significantly reduces stress levels. In recent years, [...]
Alternative decontamination using ozone technology
Ozone technology is a very well-known decontamination technology in various markets. To date, however, this type of decontamination has been used almost exclusively as a liquid process. Studies have shown that ozone is a very effective decontamination medium in itself. Ozone as a disinfectant offers some significant advantages: no need for additional chemicals for processing. Self-sufficient systems (neutral in terms of ventilation), without compressed air, [...]
Annex 1 - Infrastructure requirements (Part 2)
We talk about the questions that need to be clarified. What challenges are there when planning a new build.
Annex 1 | Are insulators mandatory?
Are only isolator/RABS systems to be used in the manufacture of medicinal products, i.e. are the cleanroom concepts D/C/B/A ("A" class achieved by safety cabinet) obsolete? What is an "open isolator" from the perspective of the testing authority? Can this also include a safety cabinet in accordance with DIN 12469?
Cleanroom planning and construction - avoid the biggest mistakes
WHEN PLANNING AND BUILDING CLEANROOMS, THERE ARE A NUMBER OF THINGS YOU CAN DO WRONG. We have compiled the typical mistakes for you and show you how to avoid them. You will receive answers to the following questions: What are the biggest mistakes in cleanroom planning and construction? How do I proceed correctly? How do I put my team together? How do I find the right [...]
Future life cycle economics
Climate change and the switch to ecologically sustainable production are increasingly influencing the pharmaceutical industry. In order to evaluate the plants of Pharmatec GmbH and the products manufactured on them with regard to their CO2 footprint, a detailed life-cycle assessment (LCA) was carried out. A product CO2 footprint (PCF) of a distillery was calculated. This PCF takes into account all life cycle phases of [...]
Annex 1 - Theses / Antitheses
The new Annex 1 has a completely new structure and is significantly more precise than in the first draft and presents new challenges for pharmaceutical companies in various chapters.
Cleanroom training - what to look out for?
Is it enough to have an external trainer visit every few years? How can the onboarding of new personnel in the cleanroom be optimized? whether one-day training, in-house training or online training - there is no "one way" to empower users and cleaning staff, and a suitable training format must be selected depending on the situation. The presentation will take a closer look at the various [...]
Qualification of a steam sterilizer
The path from load definition to completed qualification, taking into account the difficulties and challenges that a new sterilizer load can bring. Tips & tricks for implementation and avoiding stumbling blocks.