Current developments and innovations in cleanroom measurement technology
The qualification of cleanrooms and clean air systems includes the entire assessment process for compliance with the relevant normative requirements for the intended use of typical trades. A decisive component of this qualification process is the application of EN ISO 14644 and its harmonization - including the corresponding particulate limit values - with Annex 1 in the EU GMP [...].
Online bacterial count monitoring of pharmaceutical water
Here we present the latest developments in microbiological monitoring of systems for the production of pharmaceutical water. With the help of online measurements, processes can be optimized, negative developments detected at an early stage and errors avoided. Various technologies for monitoring microbial counts are available on the market. Each has its strengths and weaknesses. Flow cytometry offers decisive advantages [...]
The insulator as a barrier technology
The assessment of isolators as a barrier technology in the context of Annex 1 depends on various factors, including the manufacturing method, product characteristics and specific process and transfer risks. The choice of barrier technology is a crucial step for pharmaceutical manufacturers to ensure the highest quality standards. Isolators, as an established barrier technology, provide a physical separation between the [...]
Online water bioburden analyzer Use for the IPC
In this training presentation, I will show how results from online bioburden analysis (OWBA) can be used as an effective in-process control. Using data from GMP-qualified facilities, I will highlight practical examples of bacterial count determination and decision making. The focus is on the integration of alternative rapid methods such as flow cytometry and the transition to new QC approaches taking into account Annex 1.
Filling of highly potent products: Plant design & case study
In the rapidly evolving pharmaceutical industry, it is critical to stay abreast of current trends and regulatory requirements to ensure safety and efficacy in the manufacture of pharmaceuticals. This presentation will focus on the filling of highly potent liquid products. We will begin by exploring the latest trends in drug products and highlight [...]
Sustainability for pharmaceutical water at the limit: what makes sense?
Sustainability, energy consumption and resource conservation are key issues in all industrial processes today. Every plant manufacturer is called upon to develop the best solutions for this. However, these issues often conflict with process engineering possibilities or regulatory requirements. In this presentation, we use the example of a production plant for pharmaceutical water to show which aspects need to be taken into account and where the technological limits [...].
Cytostatic isolator: Maximum safety & Annex 1 compliance
The presentation highlights the essential challenges in the production of cytostatics under the new Annex 1 regulations and shows how the cytostatic isolator from Ortner Reinraumtechnik meets these challenges. The isolator not only offers maximum protection for personnel, but also ensures consistently high product quality through precise process control and automation. With its modular design, the [...]
Flow measurement in cleanrooms: requirements and procedures
Directionally defined airflow in cleanrooms protects products from contamination and disruptive particles are safely removed. For this purpose, a uniform air flow from the ceiling to the floor is maintained in cleanrooms with high cleanliness classes. The monitoring range extends from 0.36 to 0.54 m/s flow velocity (EU GMP guidelines, Annex 1 in Class A). This measurement is carried out on the cleanroom side after terminal filters. [...]
Safety when handling biological substances - The new DIN EN 12469
DIN EN 12469 has been defining basic requirements for microbiological safety cabinets (MSW) for almost 25 years. As a cornerstone of European standardization - and as a counterpart to the US standard NSF/ANSI 49 - it describes performance criteria and suitable tests to ensure the required protective functions. MSWs that are found to be safe according to these specifications can or must be certified on the basis of [...]
GMP-compliant and efficient cleanroom measurement technology
The provisions for the qualification of cleanliness zones in the manufacture of sterile medicinal products are set out in the current Annex 1. A crucial part of this qualification process includes the application of the classification according to EN ISO 14644 in order to ensure that measurements are carried out in compliance with the standard. Particular attention is paid to the measures from the contamination control strategy. In order to meet the requirements of the Annex [...]