Pp. 355-400 (46)
Equipment plays an active role in a pharmaceutical unit by conveying,
transforming and protecting from the environment materials and products.
Pharmaceutical equipment should observe hygienic rules in its design, construction,
installation, utilization and maintenance, as stated by GMP. As most equipment is
controlled by computerized systems, it is necessary restricting access to them and
ensuring that these can provide the same level of safety than operators (in fact higher).
Equipment is as varied as existing operations and technical approaches for performing
them, but it can be practically distributed into several groups. The first one is
represented by weighing/measurement equipment. The second one is very large and
comprises preparation equipment which is basically defined by the physical type of
dosage form (liquid, semi-solid, solid). A third group would include secondary
packaging equipment. Then a fourth group would be constituted by the booths, cabinets,
benches and RABS, which provide limited protected operational environments. And
finally we could still mention a fifth group collecting up other varied items of
equipment. With the exception of disposable equipment, it is essential securing
appropriate cleaning. Qualification, maintenance, calibration and, as required,
requalification are essential activities for ensuring appropriate equipment performance.
Access control, audit trail, BSC, cleaning, closed systems, computerized
systems, materials of construction, dead leg, drainage, isolator, labeling, PLC,
qualification, RABS, requalification, sanitary connection, sanitary design, SCADA,
smooth surfaces, UDAF.
Glez. Tablas 17, Barcelona, Spain.