Annex 1: Awakening or upheaval? Experience
This presentation takes a critical look at the past year since the new Annex 1 was "activated" as legally binding. Despite the clear clarification of GMP processes, many questions have arisen during implementation. A reliable interpretation of Annex 1 on the part of the authorities is not yet available. This often leads to difficulties in the [...]
Annex 1: Impact on plant engineering and GMP service providers
In this presentation, we will talk about the importance of CCS in the planning, construction, commissioning, qualification and operational phases of plants, in which plant construction is assigned a very important role in accordance with Annex 1. In addition to the obligation to implement this strategy, it offers a great opportunity for plant engineering and construction to establish itself as a GMP partner in the pharmaceutical world [...].
Cleanroom cleaning and disinfection: state of the art!
Adjustments to the regulations and experience gained in daily practice require a constant review, but sometimes also a complete rethink of products and processes in the cleaning and disinfection of cleanrooms. Although the newly formulated Annex 1 is explicitly only aimed at sterile production, some approaches will also be used in non-sterile areas, such as [...]
Compact ultrapure water production and distribution
BWT is presenting a new system that is particularly aimed at smaller companies or applications that require water in accordance with the applicable regulations for pharmaceutical water. The LOOPOLINE Compact product line combines the latest technology, which is state of the art for large systems, with the special requirements in terms of space, efficiency and costs. From the pre-treatment of the raw water to the [...]
Precise measurement technology for laboratories and cleanrooms
The testo 400 is ideal for high-precision measurements of all climate-relevant parameters in cleanrooms and laboratories. In order to qualify cleanrooms according to their areas of use and quality requirements, the use of precise measurement methods is essential. This is where the testo 400 comes in: - Ensuring a constant cleanroom environment thanks to precise and reliable measurements. - Continuous compliance with defined cleanroom conditions thanks to calibrated probes [...]
Climate monitoring for temperature, humidity and differential pressure
Hardly any other sector is as strictly regulated and monitored as the life science sector. Our comprehensive solutions for monitoring environmental conditions such as temperature, humidity and differential pressure provide reliable support to meet the demanding regulatory requirements at all times. In our presentation, we will discuss the benefits as well as our range of services: [...]
Highly efficient validation of sterilization processes
The testo 190 data loggers for pressure and temperature have been specially developed for use in the pharmaceutical industry and are CFR-certified. With practical benefits such as rigid and flexible probes, these compact measuring instruments support you in qualifying your data in accordance with EN ISO 285, EN ISO 17665 and EN ISO 15883. The extended measuring ranges for [...]
Annex 1 from the perspective of a plant manufacturer for ultrapure water
The new Annex 1 places higher demands on process monitoring compared to previous versions. The introduction of a comprehensive contamination control strategy, in which all process steps are monitored in particular for their contribution to the risk of contamination, increases the demands on plant engineering and process monitoring. We would like to present solutions for these requirements from the perspective of a plant manufacturer.
Online bacterial count determination for pharmaceutical water
Flow cytometry has long been established for determining microbiological quality in a wide variety of applications. In this presentation, a system will be presented for the first time that uses this technology online and almost in real time to monitor production plants for pharmaceutical water. The successful primary validation proves that all intact microorganisms including the so-called VBNC (viable but not culturable) are detected [...].
Aide Memoire of the ZLG for cleaning validation
With the publication of the aide memoire on the inspection of cleaning validation and verification in August 2023, the ZLG has published a very comprehensive guidance document. On around 50 pages, all aspects of the validation of cleaning processes are considered and the corresponding expectations of the supervisory authorities in Germany are formulated. With such a comprehensive revision (the previous document on validation [...]