Highly potent waste streams from ADC production
Antibody drug conjugates (ADCs) are highly toxic drugs that can pose significant health risks even in small quantities. Therefore, their production and handling requires specialized facilities to ensure operator safety and prevent cross-contamination. Without these customized facilities, the production of ADCs can lead to the release of hazardous substances into the environment. Preventing such contamination goes [...]
ASME BPE standard for process equipment
The ASME BPE (Bioprocessing Equipment) is a globally recognized industry standard. Compliance helps manufacturers obtain international approvals for their products by ensuring that their equipment meets the highest global standards. It covers general requirements, certification, materials, design and components for multi-use and single-use applications, as well as their manufacture and assembly. The standard will cover all [...]
Predictive maintenance of rotating machines
The failure of a single component can quickly bring an entire pharmaceutical plant to a standstill. With intelligent IIoT solutions, various system components such as air treatment systems, process pumps, agitators or motors can be monitored from the comfort of your desk with minimal installation effort. Thanks to innovative, wireless systems, installation is easier than ever before. For a self-sufficient analysis, a machine learning algorithm evaluates the status [...]
Integrated VHP technology for room decontamination
VHP technology was introduced to the pharmaceutical industry in the early 1990s and has been continuously developed in numerous GMP applications. The increased injection capacity over the years has enabled the application of this laboratory technology in all production or research volume combinations from rooms to entire manufacturing zones. Several requirements and limits for biodecontamination have been clarified in Annex 1. These [...]
Flow visualization/SmokeStudy in the aseptic core zone
The qualification of the aseptic core zone and adjacent cleanroom areas is a recurring focus of audits and inspections. One of the most frequently discussed topics is the visualization of laminar airflow in the aseptic core zone. The visualization of laminar air flow is referred to as flow visualization or smoke study. The aim of flow visualization is to demonstrate the laminar air flow in [...]
The real world, the impact of EN16615 on CCS
Dive into the complexities of disinfectant efficacy testing and learn how to navigate this critical process with confidence. This exciting session will explore the differences between testing methods, the challenges of adapting standard tests for cleanroom environments and the importance of guidance documents such as USP. Learn more about the [...]
C&Q starts in the mind: GMP in the early planning phases
The successful planning and implementation of GMP-compliant production facilities begins in the concept phase. This presentation highlights how early consideration of GMP requirements in the Concept Design (CD) and Basic Design (BD) phases efficiently prepares the Commissioning and Qualification (C&Q) process. The focus is on the integration of quality-relevant requirements into the URS ("User Requirement Specification") through a well-founded [...]
Innovations in pharmaceutical production and engineering
A presentation that offers well-founded and practice-oriented insights into the current challenges and solutions in pharmaceutical production. It will highlight technological trends and innovative approaches that open up new perspectives and demonstrate forward-looking solutions for the industry. Practical examples and successful collaborations illustrate how different processing models can be applied in real production to increase efficiency, quality [...].
Solutions for asept. Processing of obesity products
In addition to therapies for oncological applications, obesity applications are among the products with the strongest forecast market growth in the coming years. In addition to a brief introduction to the general conditions in this therapeutic area, this presentation will provide an overview of the typical challenges involved in aseptic processing and filling of the products. In the third part, fill-finish solutions available on the market and already [...]
Monitoring systems for warehouses & laboratories: what is GMP-compliant?
Precise environmental monitoring is essential for product safety in the pharmaceutical and biotechnology industry. The presentation will highlight the importance of GMP-compliant monitoring systems in warehouses and laboratories and show how they meet the strict regulatory requirements. Key topics such as data integrity, compliance and ensuring resilience in the event of an IT failure or cyberattack will be [...]