Stainless steel container from CO2-reduced production
This presentation on greenhouse gas reduction from the perspective of a medium-sized company is intended to raise awareness of the need for action to combat climate change. Starting with the description and effects of greenhouse gases, we can present developments at customers and suppliers, as well as options for action to reduce greenhouse gas emissions. Anticipating the presentation, from [...]
Evolution of insulators
The lecture deals with the evolution of isolators in pharmaceutical production, how they are characterized, i.e. what components an isolator is composed of and what tasks an isolator fulfils in its application. When isolators are used in the pharmaceutical filling of aseptic or highly active products, isolators are connected to the respective filling machines and [...]
Annex 1: The big tidy-up in the quality management system
In a deliberately provocative way, this presentation addresses the question of whether, with the new Annex 1, it is not time to adapt traditional, sometimes highly complicated and even inefficient quality structures in such a way that a well-functioning quality system in line with Annex 1 can be established while maintaining absolute patient safety. In addition to [...]
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 [...]