hygienic design - fraunhofer ipa - wir produzieren … hygienic design refers to the design of...
TRANSCRIPT
hygienic design
FRAUNHOFER iNStitUtE FOR
MANUFACtURiNg ENgiNEERiNg AND AUtOMAtiON iPA
Definition
Hygienicdesignreferstothedesignofparts,componentsand
manufacturingequipmentforeasycleaning.
introduction
Inmanufacturingenvironmentswhichhavetobekepthygienically
clean,acorerequirementistheavoidanceofmicrobialandparticu-
late contamination of the end-product. The selection of appro-
priate materials for operating utilities and their geometric design
significantlyaffecttheirsuitabilityforuseincleanmanufacturing.
Procedure
Conformityanalysesofoperatingutilitiesarecarriedoutinthe
formofexpertreports,inaccordancewiththerelevantnormsand
guidelines applying to manufacturing under clean conditions (e. g.
FDA,GMP,ISPE,ISO,EHEDG,DIN).Here,thehygienicdesignofan
operatingutilityisevaluatedwithregardtoitssuitabilityforusein
clean manufacturing areas and the respective results documented.
Thefollowingguidelinesstateconceptionanddesignspecifica-
tionsandrecommendationsconcernedwiththedesign,technical
realizationandworkmanshipofanoperatingutility.
1
hygienic design = OK
hygienic risk
roundedcornerR≥3mm
corn
er 9
0°
horizontaleFläche slope≥3°
• EHEDG(EuropeanHygienicEquipmentDesignGroup)
• FDA(FederalDrugAdministration)
• GMP(GoodManufacturingPractice)
• ISPE(InternationalSocietyforPharmaceuticalEngineering)
• ISO(InternationalStandardsOrganization)
• DIN(GermanInstituteforStandardization)
Assessment
Conformityisassessedbyvisuallyinspectingthetestpieceand
evaluating the documentation and information supplied to the
FraunhoferIPAforqualificationpurposes.Amongotherthings,
thefollowingdetailsrelevanttohygieneareexamined:
•Materialsimplemented
•Materialpairings
• Geometry
• Joiningtechniques
• Constructionaldetails
• Installedcomponents
• Surfacecoatings
2
hygienic risk hygienic design = OK
weldjointweldjoint
weldjoint
weldjoint
When examining the various hygiene details, among others,
thefollowingquestionsareconsidered:
• Aresurfacecharacteristicsconformtotherecommendations
made in the various norms and guidelines?
• Havescrewsconnectionsbeencorrectlycarriedoutfromthe
pointofviewofhygieneandaretheyeasytoclean?
• Aredeadspacespresentwhereliquidscouldaccumulate?
• Canallareasbeadequatelytreatedwithcleaningand
disinfection agents?
• Canallliquidsrunoffunimpeded?
• Havepipingconnectionsbeencorrectlycarriedoutfromthe
pointofviewofhygiene?
• Havesealsbeendesignedtoenabletheirimplementationin
hygienic areas?
Basedonthecompletedassessmentandwiththeaidofexpert
knowledge,thesuitabilityofanoperatingutilityisthendeter-
mined for use in hygienic manufacturing environments and –
whereavailable–relevantpotentialsforoptimizationpointedout.
3
hygienic design = OK
hygienic risk
1 Inner angle and edges.
2 Welded-on connections.
3 Cleanability.
4 Hygienic cable glands.
4
Areas of application
Expert reports can be compiled for all manner of products and
operating utilities planned for use in clean manufacturing areas.
This applies especially to products and operating utilities utilized
in branches of life science:
• Foodmanufacturingandprocessingindustry
• Pharmaceuticalindustry
• Cosmeticindustry
•Medicaltechnology
• Biotechnology
Assessments can be made either during the planning or
construction phases, or on existing products. An assessment
can also be made as a basis for modifying an existing product
or developing a hygienically-suitable product series.
titlE Welded-on components.
5 Rounded edges and angles.
6 Rounded body.
5
Our references
• REGENTBeleuchtungskörperAG
• FRIEDRICHSAILERGmbH
• HUBLGmbHEdelstahl-Blechverarbeitung
Our range of services
• Assessingconformitytorelevantnormsandguidelinesfor
manufacturingundercleanconditions(e.g.FDA,GMP,ISPE,
ISO,EHEDG,DIN)withregardtocleanlinessandcleanroom
suitability for critical hygienic processes
• Developingoptimizationrecommendations
• CompilinganFraunhoferIPAqualificationpackagecomprising
qualificationcertificate,qualificationdocumentandmarketable
self-adhesivequalificationlabels
• Accompanyingproductoptimizationdevelopmentsforlater
use in hygienically critical areas
• AdvisingonGMP-suitablecleanroomplanninganddesign
• Seminarsandtrainingcoursesonthesubjectofhygienicdesign
6
Fraunhofer institute for
Manufacturing Engineering and Automation iPA
Nobelstrasse12
70569Stuttgart|Germany
Director
Prof.Dr.-Ing.ThomasBauernhansl
www.ipa.fraunhofer.de
Forfurtherinformationaboutourrangeofservices,solutionsand
consultancy, please contact our experts.
Department
UltracleanTechnologyandMicromanufacturing
Contact
Dipl.-Biol.(t.o.)MarkusKeller
Phone+49711970-1560
LTAGabrielaBaum
Phone+49711970-1507
www.ipa.fraunhofer.de/cleanroom
© Fraunhofer IPA | 352 / 016e | PDF 03.10 / 07.14