Harald Flechl

Buildings for pharmaceutical production and the therein integrated infrastructure systems have in common that they have to be planned, realised and operated individually and according to the specific case. This individual character results in an increased risk of faults, which must be recognised and rectified in a timely manner so that they do not endanger the quality of the produced medicinal products.

Over the past several years, wall and ceiling systems have become the established state of the art in finishing technology. The numerous manufacturers of such systems also offer solutions that are suitable for fire zones and large, high rooms – such as warehouse storage rooms.

The design qualification process may vary depending on the project and the client's requirements and may be carried out in two or three design phases.

We operate a laminar flow above an injection moulding machine in a cleanroom, GMP Grade C (ISO 8 in operation, ISO 7/at rest). The laminar flow achieves ISO class 5 within the cleanroom area.

Beginning from the definition of the User Requirements Specification (URS) the planning phase is subdivided into four stages:

According to the new Annex 1, a Contamination Control Strategy (CCS) must be implemented for the entire cleanroom and controlled environment system of the facility.

Do you know the difference between “clean up period” and “recovery time”? Both terms are often used to describe the same procedure, but they are completely different from each other. 
Today's feature clearly explains the differences between test methods for determining the clean-up phase (Annex 1) and the recovery time (ISO 14644-3), using real-world examples.