Risk assessment - the basis for effective monitoring
The current version of EU GMP Annex 1 deals particularly intensively with the topic of risk assessment. This is a strict basic requirement for a monitoring plan and also makes sense for practical reasonsA thorough understanding of the process enables production processes to be optimally designed and monitored and additional effort in routine monitoring to be avoided. In the risk assessment, critical process steps are [...]
FacilityPro: A modern environmental monitoring system
Modern systems for environmental monitoring of cleanrooms and production facilities have become indispensable in pharmaceutical companies. They are a relatively simple tool for collecting and processing a wide range of data required for the release of a batch. The systems not only meet the data integrity requirements, but also provide additional [...]
Flow visualization & Annex 1 requirement/best practice
We explain the impact of the updated Annex 1 on flow visualization in cleanrooms. It explains how smoke studies should be correctly conducted, documented and integrated into a comprehensive contamination control strategy (CCS). Special attention is given to determining the frequency of such visualizations to meet GMP standards and ensure a safe, contamination-free environment. This content [...]
Challenges in continuous monitoring
Since the publication of the new Annex 1 at the latest, the discussion of hose lengths for particle counters has been part of every risk assessment. The defined hose length for particle counters of one meter specified in Annex 1 often causes challenges in the design of new systems and in the justification of existing systems. But how justified is the limitation to one meter and why [...]
Mini environments for dry room applications
Barrier systems in accordance with VDI 2083 Sheet 16 are used in many technical areas, such as microelectronics. The main requirement here is the purity of the room air. A particular focus is on mini-environments, which serve as a technical solution for meeting the highest purity requirements and offer many advantages. New technologies are also creating new requirements for a very dry environment. [...]
Decontamination for biosafety level 3 and 4 laboratories
The aim of this presentation is to provide an overview of decontamination procedures in laboratories and, in particular, the implementation of H2O2 decontamination. We will take a closer look at the content of a legally compliant concept (basics, risk assessment, process description,...) and common procedures (overview and technical equipment). At the end we will present a practical implementation using the example of a BSL-3 laboratory.
Conversion of existing buildings
Find out about the differences in requirements for refurbishing existing buildings from a planning and local construction supervision perspective and how you can successfully implement projects in cleanrooms and hospitals. We will show you why early planning and project preparation are the key to success. We also explain the importance of proper documentation. We round this off in our presentation with [...]
Aseptic upgrade of manufacturing areas according to Annex 1
The scope of Annex 1 has increased as a result of the latest revision. This is reflected in the increased number of pages. The subchapter "Barrier Technologies" has almost doubled in size, as topics such as background environment, gloves and decontamination methods for isolators as well as for RABS are dealt with separately. This clearly shows how the requirements for manufacturing areas and contamination control are increasing. Companies [...]
Your partner in the field of Aseptic Engin. & Cleanroom
PPT Pharma Process Technology GmbH is a service company consisting of specialists with many years of experience in the design, commissioning and operation of production facilities and production processes in the pharmaceutical industry. Our mission is to be a reliable partner for the pharmaceutical and medical device industry in all phases of the process and production cycle. From product creation, scale-up and [...]
Quali. of cleanroom class A in RABS and isolator systems
Sterility is a quality feature of the environment of cleanroom class A/ISO 5 for the manufacture of aseptic products. As the rooms of cleanroom class A/ISO 5 are usually devices/systems such as RABS or isolator technologies, the suitability for the manufacture of aseptic products must be proven via the qualification. This involves examining the regulatory requirements, the [...]