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

markus.keller@ipa.fraunhofer.de

LTAGabrielaBaum

Phone+49711970-1507

gabriela.baum@ipa.fraunhofer.de

www.ipa.fraunhofer.de/cleanroom

© Fraunhofer IPA | 352 / 016e | PDF 03.10 / 07.14