2/3 March 2021
In August, the Association of German Engineers (VDI ="Verein Deutscher Ingenieure") released three interesting VDI guidelines. The topics addressed are tightness of containment systems, identification of critical impurities in the manufacturing process of medical devices as well as requirements on the planning and implementation of central HVAC systems.
VDI Guideline: VDI 2083 Part 19: Clean room technology - tightness of containment systems - classification, planning and testing
This guideline was already published in October 2016 as a draft. The new valid version grew out of this draft.
It establishes a procedure to test and classify the tightness of containment systems, generally clean rooms or comparable systems. Moreover, it contains instructions on the setup of tight clean rooms. The procedure is analogous also applicable to other rooms whose tightness has to be verified.
VDI Guideline: VDI 2083 Part 21: Clean room technology - Cleanliness of medical devices in the manufacturing process (draft)
This document provides guidance on a risk-based approach to the identification of critical impurities of biological, chemical or particulate nature as well as - in certain cases - to the determination of acceptance criteria (cleanliness assessment) of medical devices in the manufacturing process. This applies to both medical devices themselves and their intermediates. The guideline doesn't cover the first preparation or the reprocessing of medical devices by the user, nor the assessment of biological tolerance of medical devices (biocompatibility according to the ISO standards 10993).
VDI Guideline: VDI 3803 Part 1: HVAC technology - Building and technical requirements - Central HVAC facilities (draft)
This guideline applies to the planning and implementation of central HVAC facilities where the air supply for persons is prioritised and where the components (e.g. induction device, reheater, fire dampers, air diffusers) are connected to a central HVAC device with an air pipe net. The guideline expresses fundamental requirements concerning all central HVAC facilities.
You can purchase the documents via the Beuth publisher in Berlin.