New VDI Guideline 6022, Blatt 1.1 published as Draft
Recommendation
29/30 October 2024
Organisation of a GMP-compliant Site Change
Register now for ECA's GMP Newsletter
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 However, this has been withdrawn and integrated into VDI 6022 Blatt 1.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
23.10.2024Warning Letter to Indian sterile Manufacturer due to Cross-Contamination and Particles
16.10.2024Do Parenterals have to be 100% free of Particles?
02.10.2024Does Purified Water have to be tested for Endotoxins?
18.09.2024FDA issues Warning Letter to Cell Gene Therapy manufacturer
11.09.2024Humidity in pharmaceutical Cleanroom Walls after a Leakage
28.08.2024FDA Warning Letter to pharmaceutical Manufacturer in Puerto Rico