UV Aushärteanalge Validierungsablauf

Success Story

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

A new design and safety features have increased the efficiency and safety of a curing process using UV light. The validation of the system was carried out 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.

Trace­abil­i­ty and plant operation

As already men­tioned at the begin­ning, there was a wish for live mon­i­tor­ing and trace­abil­i­ty of the process val­ues. For this pur­pose, a Siemens SIMAT­IC HMI pan­el was installed for oper­a­tion and view­ing of impor­tant para­me­ters. The plant can be oper­at­ed in the modes auto­mat­ic, man­u­al and test run with­out prod­ucts. In auto­mat­ic mode, process val­ues can be observed as val­ues or in dia­grams and can be ana­lyzed and com­pared after­wards in the archive. There is a user admin­is­tra­tion with defined rights for indi­vid­ual users and user groups. Recipes with a desired num­ber of recipe para­me­ters can be defined for the respec­tive prod­ucts to be exposed and select­ed dur­ing oper­a­tion. The system’s con­trol sys­tem con­tin­u­ous­ly checks com­pli­ance with all lim­it val­ues and issues warn­ing mes­sages if these are exceed­ed or not reached, or aborts the expo­sure process depend­ing on the def­i­n­i­tion. Fur­ther­more, all process and recipe val­ues are for­ward­ed to high­er-lev­el IT sys­tems via OPC UA, where they can be fur­ther processed in data­bas­es or oth­er tools.

The Audit Trail func­tion­al­i­ty of the SIMAT­IC HMI is used to ensure that all changes in the process as well as the change and dele­tion actions of each user can be con­tin­u­ous­ly mon­i­tored for qual­i­ty assur­ance pur­pos­es. The audit trail data is stored on an SD card in the HMI, which can be eas­i­ly read out if required.

The imple­ment­ed func­tion­al­i­ties regard­ing trace­abil­i­ty can be trans­ferred to a large num­ber of pro­duc­tion machines. Espe­cial­ly for med­ical or safe­ty-rel­e­vant prod­ucts, many end cus­tomers require a record of all process para­me­ters and mea­sured val­ues of the indi­vid­ual prod­uct to prove com­pli­ance with the required qual­i­ty. We can reli­ably imple­ment these require­ments with the tech­nolo­gies shown here and others.

Our expe­ri­ence in the field of GMP qual­i­fi­ca­tion makes us a com­pe­tent part­ner and sup­pli­er in this area.

Contact Person
Maximilian Aretz
Maximilian Aretz, M. Eng.
Software Engineer
Specializations: Control engineering, IoT, Industry 4.0, Machine Vision, DBMS
with system components from

Pilz GmbH & Co. KG
Felix-Wankel-Straße 2
73760 Ostfildern



Siemens Aktiengesellschaft
Werner-von-Siemens-Straße 1
80333 München