Increas­ing process and user safe­ty with a med­ical UV cur­ing sys­tem devel­oped accord­ing to GAMP 5

The back­ground to the new­ly devel­oped sys­tem was the recur­ring qual­i­ty prob­lems, insuf­fi­cient oper­a­tor safe­ty and a lack of trace­abil­i­ty. The prod­ucts are bond­ed with an adhe­sive that is cured by irra­di­a­tion with UV light. This repeat­ed­ly result­ed in defec­tive bond­ing, which was attrib­uted to insuf­fi­cient UV irra­di­a­tion. Thus, the require­ments for the new sys­tem were live mon­i­tor­ing of process val­ues, such as expo­sure time, UV inten­si­ty and recipe para­me­ters, as well as com­plete data stor­age for trace­abil­i­ty of process para­me­ters and oper­a­tor activities.

GMP qual­i­fi­ca­tion and the V‑model

For man­u­fac­tur­ers of prod­ucts for med­ical use, qual­i­fi­ca­tion of a new sys­tem is a fun­da­men­tal part of qual­i­ty man­age­ment and an impor­tant pre­req­ui­site for main­tain­ing man­u­fac­tur­ing licens­es. For this rea­son, the entire project was imple­ment­ed in accor­dance with GAMP 5 based on the V‑model and the soft­ware was val­i­dat­ed in com­pli­ance with the EU GMP reg­u­la­tion, which con­sists of the fol­low­ing com­po­nents: 

• DQ – Design Qualification
• IQ – instal­la­tion qualification
• OQ – func­tion­al qual­i­fi­ca­tion -(Oper­a­tional Qualification)
• PQ – Per­for­mance Qualification

Thus, it must be demon­stra­bly pos­si­ble to show that a plant or machine has been con­struct­ed and designed in accor­dance with GMP (DQ), has been con­nect­ed and installed as planned (IQ), func­tions prop­er­ly in the intend­ed oper­at­ing range (OQ) and per­forms as required (PQ). All these cri­te­ria of the val­i­da­tion process were tak­en into account by Qual­i­ty Automa­tion GmbH dur­ing the imple­men­ta­tion of the project in close coop­er­a­tion with the customer.

User safe­ty

In the pre­vi­ous sys­tem, the door of the expo­sure cham­ber was opened and closed man­u­al­ly, with­out any safe­ty pre­cau­tions. In the new sys­tem, the con­trol of the door is auto­mat­ed and the posi­tion of the door is con­tin­u­ous­ly mon­i­tored by induc­tive sen­sors and a PILZ safe­ty switch. This serves the pur­pose, for exam­ple, that the door is not opened after an expo­sure until the UV lamp is switched off. If the door opens due to exter­nal influ­ences dur­ing the expo­sure process, the PILZ safe­ty switch imme­di­ate­ly switch­es off the UV lamp and issues an alarm in opti­cal and acoustic form.