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.