New VDI Guideline 6022, Blatt 1.1 published as Draft

GMPs for Equipment, Utilities and Facilities

Recommendation

3-5 June 2025
Munich, Germany

GMPs for Equipment, Utilities and Facilities
Good Engineering Practice for Pharmaceutical Companies and Suppliers

In June, the VDI published the new guideline 6022 Blatt 1.1 as a draft for comment. The new document is intended to expand on the existing Guideline 6022 Blatt 1, which describes the overall hygiene assessment of ventilation and air-conditioning systems.

The new Blatt 1.1 concretises the requirements of VDI 6022 Blatt 1 with regard to decentralised air handling systems and units with or without fresh air connection (e.g. PIFFs - Plenum Integrated Filter Fan Units).

There was already a guideline of the same name, VDI 6022 Blatt 1.1:2012-08, which described how to create an inspection certificate according to VDI 6022 Part 1. However, this has been withdrawn and integrated into VDI 6022 Blatt 1. The same procedure is planned with Blatt 1.1, which is now published as a draft, i.e. direct publication as a whiteprint after the comment or objection process.

The draft of VDI Guideline 6022 Blatt 1.1 is available from Beuth Verlag.