New VDI Guideline 6022, Blatt 1.1 published as Draft

Recommendation
13/14 May 2025
GM Requirements for Planning, Qualification and Operation
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 However, this has been withdrawn and integrated into VDI 6022 Blatt 1.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.
Related GMP News
05.05.2025Another FDA Warning Letter for Indian API manufacturer
30.04.2025Cross-Contamination at Indian pharmaceutical manufacturer
23.04.2025Data Integrity Violations at an OTC Manufacturer
23.04.2025Warning Letter to Indian API Manufacturer due to Restricted Access