Qualification tests / Re-qualification tests
Qualification and Requalification Testing for Cleanrooms: Requirements, Objectives, and Implementation Qualification and requalification testing for cleanrooms is of critical importance for product quality and quality management in industries such as the pharmaceutical, medical, and semiconductor sectors. These tests ensure that cleanrooms meet the required specifications and consistently maintain the prescribed conditions. In this presentation, we will discuss the phases in […]
Qualification of cleanroom systems
The presentation will explain the difference between qualification and validation. The qualification of a cleanroom system is explained. The User Requirement Specification (URS), the Qualification Master Plan (QMP), the Design Qualification (DQ), the Installation Qualification (IQ), the Operational Qualification (OQ) and the Performance Qualification (PQ) will be discussed. The relevant standards and guidelines are presented, as well as the determination of all [...]
BIM Method in the Design Process
The BIM Method in the Design Process This presentation on the BIM method in the design process provides a clear overview of the practical implementation of Building Information Modeling. From the perspective of an experienced user, it examines all key aspects—from the initial steps in the pre-project phase through the entire project duration to the processes following project completion. The practical case study […]
GMP Maintenance 4.0 Launched
GMP maintenance is undergoing a transformation: moving away from reactive measures toward a data-driven, proactive strategy. The goal is to detect equipment failures early, reduce unplanned downtime, and increase availability—without compromising on the strict requirements of GMP. This requires a clear maintenance strategy and organizational structure. Modern sensor technology, digital trend analyses, and smart evaluations make it possible to […]
GxP Today: A Look at the Key Challenges
In GxP-regulated environments, companies face a range of recurring challenges that involve both technical and organizational aspects. Issues such as data security and redundancy are particularly critical, as all information must be traceable, protected, and available at all times. At the same time, the integration of a wide variety of systems—from sensor technology and LIMS/MES to cloud and on-premise structures—is becoming increasingly […]
Material and planning of a cleanroom airlock
An insight into the various materials for personnel airlocks and cleanroom furniture is provided. The focus will be on HPL with its optimum resistance to cleaning agents and disinfectants. We will also discuss the most important points when planning a personnel airlock.
Material and planning of a cleanroom airlock
An insight into the various materials for personnel airlocks and cleanroom furniture is provided. The focus will be on HPL with its optimum resistance to cleaning agents and disinfectants. We will also discuss the most important points when planning a personnel airlock.
Material and planning of a cleanroom airlock
An insight into the various materials for personnel airlocks and cleanroom furniture is provided. The focus will be on HPL with its optimum resistance to cleaning agents and disinfectants. We will also discuss the most important points when planning a personnel airlock.
Material and planning of a cleanroom airlock
An insight into the various materials for personnel airlocks and cleanroom furniture is provided. The focus will be on HPL with its optimum resistance to cleaning agents and disinfectants. We will also discuss the most important points when planning a personnel airlock.