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.
US FDA inspections: Typical pitfalls
About Dr. Ralf AubeckDr. Ralf Aubeck works as Principal Consultant and Industry Certified GMP Auditor for gempex GmbH worldwide. He studied chemistry at the Ludwig-Maximilians-University in Munich (LMU) and received his doctorate in 1991 as Dr. rer. nat. on chemical-pharmaceutical biosensors.More than 25 years of experience in responsible positions in quality management of German and American smaller and [...]
Cleanroom personnel
Examples from the cleanroom industry will be used to demonstrate the types of contamination that can be avoided by humans.
Improving mobile particle monitoring
Mobile particle monitoring is characterized by many repetitive activities, which are very time-consuming on the one hand, but also pose the risk of compromising data quality, e.g. due to transmission errors. The presentation shows how digitization solutions can be used to optimize mobile particle monitoring in terms of time, quality, costs and sustainability.