Let us start by looking at some of the recommendations for premises.
There are a number of specific requirements for premises that are used for the manufacture of sterile products. Unnecessary entry to all processing areas should be avoided. The design of the premises should support this. It should be possible to observe operations from the outside.
Processing takes place in suites of rooms with different classifications, depending on the activities carried out in them. The classifications relate primarily to the supply of air to the rooms. We will be looking at this topic in more detail in the second part of this session.
Assess whether the rooms are designed to reduce the accumulation of dust, with all exposed surfaces being smooth, impervious and unbroken. (The trainer may want to show the slides of photographs of suitable and unsuitable premises and finishing).
There should also not be excess equipment, cupboards or tools in the area. Doors should also be suitably designed and sliding doors should be avoided in sterile product manufacturing areas, as these cause areas where it is difficult to clean.
Ideally there should be false ceilings, which are sealed so that no dirt can fall from the void above. This should also permit access to light fittings from above allowing maintenance without stopping production. Wherever possible, pipes and ductwork should be outside the area, or boxed in.