August 2004 – Qualified Hygienic Design (QHD) stands for a two-phase testing system for the hygienic design and the cleanibility of components, machinery and plant for aseptic or sterile applications.

QHD enables the user

  • to prove theoretically that the design of components and plant pays due regard to hygienic requirements (phase 1)
  • to prove cleanibility in practice by way of a quick test (phase 2)
  • to issue an own certificate for suitable lay-out and cleanibility of components and plant for both phases
  • Users implementing QHD document adherence to the basic rules of hygienic design and guarantee easy cleanibility.
  • QHD helps to take into account any pertinent provisions relating to mandatory hygienic aspects.
  • QHD points out at the earliest possible stage, i.e. during the development, where potential trouble spots may occur. This saves time and money.
  • QHD indicates critical points in a design. Where modifications are not practicable, appropriate reference may be integrated into operation instructions.
  • QHD documents that the manufacturer of the machine, or, as applicable, component, has dealt intensively with all hygienic aspects and that the hygienic design complies with the state of the art.
  • QHD guarantees to the buyer of components and machinery that they can be cleaned easily.

The member companies of the Sterile Process Engineering Group affiliated with the VDMA Process Plant and Equipment Association have, for many years now, dealt extensively with any imaginable aspect of hygiene. They play a pro-active part in European and national standardisation and have, as a result, published quite a number of VDMA standards on sterile processing technology.

 

To pay due regard to the applicable formal requirements and customer requirements alike,  and to document the excellent level on which the member companies of the Sterile Process Engineering Group operate – also with respect to cleanibility – their combined efforts have lately focussed on the development of a system testing for cleanibility of components.

 

This is how the co-operation of companies, their association and the Chair for Machinery and  equipment Sciences of the Munich Institute of Technology has finally resulted in the „Qualified Hygienic Design“ (QHD) testing system.