When designing any pharmaceutical manufacturing facility, it is most important to set out the initial principles upon which that design will be based.
Authorized Persons
Only authorized persons should be able to enter production area and an access control system should be installed to restrict the unnecessary access to critical zones.
The facilities should be designed in such a way as to allow for manufacturing to be carried out in a logical series of consecutive steps and should permit the logical positioning of equipment to minimise the possibility of confusion, mix-ups and cross-contamination between different products.
Smooth, Impervious and Unbroken
Exposed surfaces should be smooth, impervious and unbroken in order to minimize shedding or accumulation of air borne particles or microorganisms.
Hand-washing facilities should be provided only in the changing rooms, not in areas where aseptic work is done.
