Cleanroom monitoring: Has data integrity been considered?
Cleanroom monitoring: Data - Has data integrity been considered? Timo Kretzschmar sheds light on the topic of data integrity in valid applications on qualified infrastructure. Is it the great unknown? What needs to be considered when it comes to backups and archiving. Can cloud systems be used and what needs to be considered when using them? How can cloud systems be used for control and data management. [...]
Working and acting in accordance with Annex 1 (Part 3)
We discuss the issues that need to be clarified for staff, management and supervision.
Pharma/biotech robotics: so much more than just logistics
The real added value of robotics in production plants lies in productivity and product safety. The natural trend towards automation through the use of a robotic solution often relates to logistical tasks: Depalletizing, palletizing, transporting material between different locations. However, in pharma/biotech production facilities, there are many challenging and ground-breaking tasks that can be solved with creative robotic solutions, [...]
Annex 1 - What does this mean for your monitoring system?
Do you produce according to Annex 1? What requirements result from Annex 1 for the cleanroom monitoring system? What are the requirements and how should Annex 1 be classified? What has changed with the new version published in 2022? Get a compact overview with all the essential information on the topic of monitoring in Annex 1
Cleanroom technology - Energy efficiency, VDI 2083 Sheet 4.2
Cleanroom technology - Energy efficiency, VDI 2083 Sheet 4.2, Why a standard - there are laws and regulations? The standard VDI 2083 Sheet 4.1 Cleanroom technology "Energy efficiency" Why this standard, when there are laws, regulations and other rules on energy saving? Content of this standard: Which topics are dealt with specifically for the cleanroom? - Planning requirements [...]
Presentation of a Fast Track Brown Field Project in Biotech
Two additional production lines of 16 tons of immunoglobulins per year are created. CSL Behring is expanding its production capacity in Berne to meet the high demand for immunoglobulin products. The project, called Protinus, is being realized at the Wankdorf site. It includes the construction of a multi-storey building with two production lines. The new building will be connected to the [...]
Fully automated and validatable decontamination processes
The basis of the pharmaceutical industry is the GMP-compliant (Good Manufacturing Practice) production of sterile and high-quality products. The aseptic production of parenterals must take place under controlled process conditions, which is why effective and tested disinfection processes are required to minimize the bacterial contamination of surfaces (bioburden). Due to the high time expenditure and the risk of insufficient [...]
Best Practice - Cleanroom Monitoring System
Best practice cleanroom monitoring system: What does implementation look like in practice? How is the system set up? How are the measuring devices installed in practice? What do processes such as alerting or reporting look like in practice? Experience a practical overview of the topic of monitoring.
Phase III: Performance qualification of the disinfection regime
Phase III: Performance qualification of the disinfection regime A review of the final phase of the implementation of a cleaning and disinfection system; the performance qualification phase, also called Phase III or in-situ field studies. The purpose of this phase is to demonstrate, through the generation of data, the effectiveness of a cleaning and disinfection procedure once it is used in the facility. The presentation outlines possible structures [...]
IT infrastructure on the way to 4.0
About Dr. Georg SchwarzDr. Georg Schwarz is a chemist and has been responsible for IT validation at gempex for over 6 years, before that he gained 20 years of experience in the pharmaceutical industry (IT trainer, application manager, IT quality and security manager) The presentationInfrastructure 4.0 is a presentation about the advantages and disadvantages of a GMP-compliant, [...]