Opposites? Hygiene and efficiency in ventilation technology.
Room air technology is an important factor in complying with hygiene requirements in cleanrooms. But what do ventilation and air conditioning solutions need to look like in order to meet the highest hygiene standards and be very efficient in operation? Are these opposites or not? The aim of this presentation is to show which aspects need to be taken into account. This will [...]
Overall qualification concept with supplier documents
Fill & finish lines for sterile dosage forms have been increasingly in demand on the market in recent years. In order to conserve internal resources at the pharmaceutical operators, it is possible to purchase qualification packages from the suppliers of the associated machines and systems; even if the responsibility for carrying out the qualification to meet the high regulatory requirements is [...]
Energy efficiency in cleanrooms
Operating cleanrooms requires expenditure that is reflected in the operating costs. Part of the operating costs of cleanrooms is due to energy costs. Operating a cleanroom requires electricity, heating and cooling. It is in the nature of things that companies try to keep operating costs low. Due to the (previously) low energy prices, the high [...]
Cleanroom crane with semi-automatic system and pendulum damping
Innovation through recombination - in practice, what works better wins The product solution: The cleanroom crane with semi-automatic operation and pendulum damping is currently unrivaled in the cleanroom world and was created in several steps by applying existing technologies and elements to new areas of application. The focus is on proactively recognizing opportunities and, by combining existing [...]
The new Annex 1 & its influence on fill-finish systems
This presentation contains a brief general introduction to Annex 1 and its history. In addition to a presentation of the main changes compared to previous versions (e.g. Contamination Control Strategy), the most important factors influencing the design and implementation of new fill-finish systems will be discussed. The main topics covered include cleanroom classification, system design, air velocity measurement, first-air, glove testing, reduction of manual interventions, [...]
FactoryLayer© - "Next Generation" - GMP Monitoring
With the FactoryLayer© GMP Monitoring System FL-EMS, RETEL Neuhausen AG has a scalable GMP monitoring system that can be optimally adapted to the customer's needs. The FL-EMS system is characterized by its multidimensional scalability in the following disciplines: - Sizing: Rooms | Floors | Buildings | Campus | Company-wide - Data sources: Sensors [...]
Challenges in the processing of OEB5(+) products
This presentation provides an introduction to the topic of highly active substances (definition and difference between OEL and OEB) in order to create a uniform basic understanding. The challenges that arise for the aseptic processing of high-class OEB products will be demonstrated through realized customer projects. Typical challenges include system design, simultaneous product and operator protection, use of pressure cascades, filter systems, system cleaning [...]
Flexible parallelization of ATMP production
More and more cell therapy products are showing promising therapeutic success. Nevertheless, commercial success and market success are still pending. Why? Most current approaches face the challenge of bridging the gap between early clinical trials and efficient production. In this presentation, we will introduce MOSAIC, our vision of the production system of the future. The goal of MOSAIC is to [...]
Development of a hygiene concept within the framework of GMP Annex 1
Ms. Ernst will take you on an exciting journey on how a hygiene concept can be rolled out for a manufacturing company, starting with the regulatory requirements such as Annex 1, DIN EN 14644, VDI 2083 through to the awarding of services. She reports from the experience of past projects on how to sustainably manage to train your own staff [...].
The new ISO 17665 - Validation of sterilization processes
Ensuring the safety and quality of products in the pharmaceutical industry relies heavily on effective sterilization processes. Validation of these processes is essential, and detailed guidance on developing, validating and controlling the use of sterilization processes is provided in the current edition of the ISO 17665 standard from 2024. In addition, the guidelines of the European Pharmacopoeia [...]