Syndica Microbiology Laboratory Design Webinar- Mohammad M Sepahi.pdf

Definition of Microbiology Lab. General Layout
WHO good practices for pharmaceutical microbiology laboratories, TRS
961 , 2011 . Annex 2
Page
74 : 2.1 .

2.1.1 Microbiology laboratories and certain support equipment (e.g. autoclaves and glassware)
should be dedicated and separated from other areas, especially from production areas

2 1 2 Microbiology laboratories should be designed to suit the operations to be carried out in
them There should be sufficient space for all activities to avoid mix ups contamination and
cross contamination There should be adequate suitable space for samples reference organisms
media (if necessary, with cooling), testing and records Due to the nature of some materials (e g
sterile media versus reference organisms or incubated cultures), separate storage locations may
be necessary

1. Part I: Microbiology Laboratory Design Principles
Definitions, Regulation and Standards, fromDesign to Qualification
Mohammad Mahdi Sepahi, PhD
CEO of Renatan Tech Zist Co.
1-Dec-2021
12:30–13.45 PM
www.renatantech.ir
[email protected]
[phone]
I
II
II
Design, Construction and Commissioning
of Microbiology Laboratories Based on
Risk Management

2. Our Agenda
Introduction
Cleanroom Facility
Design Object
Engineering Design
Process
Conceptual, Basic
and Detail Design
Construction
Materials of
Construction &
Surface Finishes
Commissioning
Start-Up and Turnover
of Facilities, Systems
and Equipment
2
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral
Maintenance
December 2021Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD

3. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
3
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
❑WHO,GoodPracticesForPharmaceuticalMicrobiologyLaboratories,TRS961,2011.Annex2
❑FDA,OfficeofRegulatoryAffairsORALaboratoryManualVolumeII
❑USP,GeneralInformation〈1117〉MicrobiologicalBestLaboratoryPractices
❑FDA,GuidetoInspectionsofMicrobiologicalPharmaceuticalQualityControlLaboratories
❑PIC/S,RecommendationonSterilityTesting,PI012-3,PIC/SSeptember2007
❑WHO,LaboratoryBiosafetyManual,LaboratoryDesignandMaintenance,4
th
Edition2020
❑CDC,BiosafetyinMicrobiologicalandBiomedicalLaboratories,5thEdition2009
❑WHO,LaboratoryBiosafetyManual,Thirdedition,2004
❑Eurachem,AccreditationforMicrobiologicalLaboratories,Secondedition,2013
References and Guidelines
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

4. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Planning(BasicKnowledge,ProjectTeam,NeedsAssessment,URB&URS)
Designing(Conceptual,Basic,Detail)
DesignQualification(DQ)
Building(EndPlanning,ConstructionDocumentDevelopment,Procurement,Installation)
InstallationQualification(IQ)
Commissioning(Pre-Assessment,Balancing)
OperationalEquipmentInstallation
OperationalQualification(OQ)
Delivery(Temporary)
Operation
PerformanceQualification(PQ)
Delivery(Permanent)andMaintenance
FRAMEWORK OF A MICROBIOLOGY LABORATORY PROJECT
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

5. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
5
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

6. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
6
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

7. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
7
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Risk Assessment

8. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
8
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Risk Analysis and Mitigation Matrix (RAMM) -A risk tool for quality management

9. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
9
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Risk Analysis and Mitigation Matrix (RAMM) -A risk tool for quality management

10. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
10
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
User Requirements Brief (URB)
Oncetheriskassessmentandneedsassessmenthavebeenperformed,anoutlinedocumentshould
bedevelopedtocommunicatetheoutcomesoftheseassessmentstothedesigners.Thisdocumentis
theuserrequirementbrief.
User Requirements Specification (URS)
Theuserrequirementspecificationmaybedevelopedbyanarchitectordesignerforsmallorsimple
projectsorbyalargerdesignteamformorecomplexprojects.Therearelikelytobeseveralroundsof
discussionbetweentheseniormanagement,thelaboratorymanagement,theprojectmanagerand
thedesignteamtoagreeonthemostappropriatefinaluserrequirementspecificationtoinformthe
facilitydesignandlayout.Otherissuesalsoneedtobeconsidered,suchasmaterialstobeused,
surfacefinishes,laboratoryfurniture,evencolourschemesandtheappearanceofthefinished
laboratory.

11. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Conceptual
Design
Schematic Design
Definition of area classification
Definition of in/out paths(Flows)
AHU Segregation
Differential Pressure
EquipmentArrangement
DetailedDesign
Piping
Ducting
Plumbing
Lighting/Wiring
BasicDesign
Flooring, Wall and Ceiling Material
Lighting Zonification and Lux Level
Single Phase, Three PhaseSocket
Data and Telephone Socket
Access Control, CCTV
EMS/MonitoringDevices
Design
Phase
11

12. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
12

13. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Conceptual Design
Theconceptualdesign(alsoknownasoutlinedesign)isthefirststepinthedesignprocessandgives
animpressionorvisionoftheproject.Itcontainstheriskcontrolmeasurestobeincludedasdefinedby
theriskassessment.Theconceptdesignisthefirstopportunityforthedesignteammemberstostudy
thedesignandprovidefeedbackbasedontheirunderstandingoftheneedsoftheusersasarticulated
intheuserrequirementbrieforuserrequirementspecification.Thisdesignstagehelpsrefineproject
costdataandprojecttimescalesandcaninformstakeholderswhattoexpectoftheplannedfacility.
13

14. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Conceptual Design Drawings
oDefinitionofGenerallayout
oDefinitionofAreaClassification
oDefinitionofDP,TandRH
oDefinitionofin/outpathsforstaff/material(Personnel,Product,Waste,QCSample,Materialand
EquipmentMovementFlow)
oDefinitionofthemainprocessequipmentandutilities(EquipmentArrangement)
oDefinitionofAHUZonification
oDefinitionofAHUandECFFiltration
14

15. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
Environment
Premises
15

16. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
WHO good practices for pharmaceutical microbiology laboratories, TRS 961, 2011. Annex 2
Page 71: Pharmaceutical microbiology laboratories may be involved in:
❑Sterility testing;
❑Detection, isolation, enumeration and identification of microorganisms (bacteria, yeast
and molds) and testing for bacterial endotoxins in different materials (e.g. starting
materials, water), products, surfaces, garments and the environment; and
❑Assay using microorganisms as part of the test system
16

17. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
WHO good practices for pharmaceutical microbiology laboratories, TRS 961, 2011. Annex 2
Page 74: 2.1. Premises:
❑2.1.1 Microbiology laboratories and certain support equipment (e.g. autoclaves and glassware)
should be dedicated and separated from other areas, especially from production areas
❑2.1.2Microbiologylaboratoriesshouldbedesignedtosuittheoperationstobecarriedoutin
them.Thereshouldbesufficientspaceforallactivitiestoavoidmixups,contaminationand
cross-contamination.Thereshouldbeadequatesuitablespaceforsamples,referenceorganisms,
media(ifnecessary,withcooling),testingandrecords.Duetothenatureofsomematerials(e.g.
sterilemediaversusreferenceorganismsorincubatedcultures),separatestoragelocationsmay
benecessary
17

18. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
WHO good practices for pharmaceutical microbiology laboratories, TRS 961, 2011. Annex 2
Page74:2.1.Premises:
❑2.1.3Laboratoriesshouldbeappropriatelydesignedandshouldtakeintoaccountthesuitability
ofconstructionmaterialstoenableappropriatecleaning,disinfectionandminimizetherisksof
contamination.
❑2.1.5Accesstothemicrobiologicallaboratoryshouldberestrictedtoauthorizedpersonnel.
Personnelshouldbemadeawareof:
—theappropriateentryandexitproceduresincludinggowning;
—theintendeduseofaparticulararea;
—therestrictionsimposedonworkingwithinsuchareas;
—thereasonsforimposingsuchrestrictions;and
—theappropriatecontainmentlevels.
18

19. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
WHO good practices for pharmaceutical microbiology laboratories, TRS 961, 2011. Annex 2
Page74:2.1.Premises:
❑2.1.6Laboratoryactivities,suchassamplepreparation,mediaandequipmentpreparationand
enumerationofmicroorganisms,shouldbesegregatedbyspaceoratleastintime,soasto
minimizerisksofcross-contamination,false-positiveresultsandfalse-negativeresults.Where
nondedicatedareasareused,riskmanagementprinciplesshouldbeapplied.Sterilitytesting
shouldalwaysbeperformedinadedicatedarea.
19

20. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
Food and Drug Administration Office of Regulatory Affairs ORA Laboratory Manual Volume I
Page12:6.3.FacilitiesandEnvironmentalConditions
6.3.1.SuitabilityofFacilitiesandEnvironmentalConditions
❑Thelaboratoryenvironmentalconditionsfacilitatethecorrectperformanceofanalyticaltesting.
Examplesofenvironmentalinfluencesareenergysources,lighting,biologicalsterility,dust,
humidity,andtemperature.Thelaboratorymonitorscriticalenvironmentalconditionstoensure
thatresultsandthequalityofthemeasurementarenotadverselyaffectedorinvalidated.
20

21. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
Food and Drug Administration Office of Regulatory Affairs ORA Laboratory Manual Volume II
Page3-7:6.Procedure
6.1.Environment
❑A.Thelaboratoriesaredesignedtoprovidespace,engineeringcontrols,andproper
environmentalconditionsforoptimalsamplestorage,samplehandling,analysis,and
calibrations,inaccordancewithgenerallaboratorypractices,safety,andapplicableFederal,State
andlocalregulations.
❑B.Facilitiesconsistoflaboratories,officeareas,storagerooms,andspecialpurposeareas.
Laboratoriesaresectionedbytestingcompatibilityanddesigncapabilities.Floorsinthe
laboratoriesareconstructedfromamaterialthatisandeasilydisinfected.Microbiologylabsare
designedtominimizeareaswithcrresistanttomostchemicalspillsacksorfibersthatcouldserve
toaccumulatedebrisandserveasanareaforgrowthofmicroorganisms.Floorsareclean,dry,
andinsoundconditionsotherearenotrippinghazards.
21

22. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
Food and Drug Administration Office of Regulatory Affairs ORA Laboratory Manual Volume II
Page3-7:6.Procedure
6.1.Environment
❑H.Separatestorageareasofsufficientsizearepresentinthelaboratorytoensurethatglassware,
portableinstrumentation,microbiologicalmedia,supplies,reagents,solvents,chemicals,
hazardousorregulatedwastesandreferencestandardsandmaterialsareproperlystored.
Separatestorageareaspreventcontaminationordegradation,ensurethelaboratoryisin
compliancewithregulatoryauthorities,meetsecurityneeds,assurepersonnelsafety,and
minimizeclutter.
22

23. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
Food and Drug Administration Office of Regulatory Affairs ORA Laboratory Manual Volume II
Page3-7:6.Procedure
6.3.Segregation
❑B.Samplereceivingandstorageisconductedindesignatedareaswhichareseparatefromthe
mainpartofthelaboratory.
❑C.Thelaboratoryareasareseparatedfromothersectionsinthebuilding,suchasAdministrative
Services,InvestigationBranch,ComplianceBranch,lunchroomandconferenceroomfacilities.
❑D.Areasofspecializedtestingareseparatedfromgeneralworkareas.
❑E.Chemical,standards,referencematerialsandculturesarestoredseparatelyfromsamples.
❑F.Microbiologymediapreparationandsterilizationareasareseparatedfromworkareasto
preventcontaminationofcleanmedia.
23

24. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
General Information 〈1117〉Microbiological Best Laboratory Practices
LABORATORYLAYOUTANDOPERATIONS
❑Laboratorylayoutanddesignshouldcarefullyconsidertherequirementsofgoodmicrobiological
practicesandlaboratorysafety.Itisessentialthatcross-contaminationofmicrobialculturesbe
minimizedtothegreatestextentpossible,anditisalsoimportantthatmicrobiologicalsamples
behandledinanenvironmentthatmakescontaminationhighlyunlikely.
24

25. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Microbiology Lab. General Layout
General Information 〈1117〉Microbiological Best Laboratory Practices
LABORATORYLAYOUTANDOPERATIONS
❑Ingeneral,alaboratoryshouldbedividedintocleanorasepticareasandlivecultureareas.Areas
inwhichenvironmentalorsterileproductsamplesarehandledandincubatedshouldbe
maintainedcompletelyfreeoflivecultures,ifpossible.Ifcompleteseparationofliveandclean
culturezonescannotbeaccomplished,thenotherbarriersandasepticpracticesshouldbe
employedtoreducethelikelihoodofaccidentalcontamination.Thesebarriersincludeprotective
clothing,sanitizationanddisinfectionprocedures,andbiologicalsafetycabinetsdesignatedfor
cleanorasepticoperationsonly.Proceduresforhandlingspillsormishapswithlivecultures
shouldbeinplace,andallrelevanttechnicalpersonnelshouldbetrainedregardingthese
methods
25

26. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of
Microbiology
Lab. General
Layout
26

27. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
27

28. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
28

29. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
WHO good practices for pharmaceutical microbiology laboratories, TRS 961, 2011. Annex 2
Page74:2.1.Premises:
❑2.1.7Considerationshouldbegiventodesigningappropriateclassifiedareasfortheoperations
tobeperformedwithinthemicrobiologylaboratory.Theclassificationshouldbebasedonthe
criticalityoftheproductandtheoperationbeingcarriedoutinthearea.Sterilitytestingshould
beperformedunderthesameclassasusedforsterile/asepticmanufacturingoperations.
Appendix1showsrecommendationsforzoneclassifications.
Definition of Area Classification
29

30. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
WHO good practices for pharmaceutical microbiology laboratories, TRS 961, 2011. Annex 2
Page75:2.4Sterilitytestfacilities
❑2.4.3ThesterilitytestingshouldbecarriedoutwithinaGradeAunidirectionalairflowprotected
zoneorabiosafetycabinet(ifwarranted),whichshouldbelocatedwithinacleanroomwitha
GradeBbackground.Alternatively,thetestingcanbecarriedoutwithinabarrierisolator.Care
shouldbetakenwiththedesignofthefacilitylayoutandroomairflowpatterns,toensurethat
theunidirectionalairflowpatternsarenotdisrupted.
Definition of Area Classification
30

31. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Recommendation on Sterility Testing, PI 012-3, PIC/S September 2007
Page3:8.1.1Classification
❑8.1.1.1ThesterilitytestshouldbeconductedwithinaclassAlaminarairflowcabinetlocated
withinaclassBcleanroom,orinanisolatorthatneednotbelocatedwithinacontrolled
environment.ThetestmayalsobeperformedwithinaclassAcleanroom,ifavailable.Sterility
testingshouldbecarriedoutinaworkzonethatofferssufficientspaceandmaterialshouldbe
placedinsuchawaythatitdoesnotdisruptthelaminarairflow.
❑23.Theairclassificationrequiredforthebackgroundenvironmentdependsonthedesignofthe
isolatoranditsapplication.Itshouldbecontrolledandforasepticprocessingitshouldbeatleast
gradeD.(Annex1PIC/SGMP)
Definition of Area Classification
31

32. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Area
Classification
32

33. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Air Lock Concepts
33

34. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of Area
Classification
34

35. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of DP, T and RH
Recommendation on Sterility Testing, PI 012-3, PIC/S September 2007
Page4:8.1.2Airsupply
❑8.1.2.2Thereshouldbeapressuredifferentialofnotlessthan10to15Pascals(guidancevalue)
betweeneachoftheareas,i.e.ambient/airlockandairlock/testroom.Pressurereadingsshould
betakenandrecordedfromexternallymountedgaugesunlessavalidatedcontinuous
monitoringsystemisinstalled.Asaminimum,readingsshouldbetakenpriortooperatorentry
tothetestsuite.Pressuregaugesshouldbelabelledtoindicatetheareaserved,theacceptable
specification,andwhetherornotthereadingisabsoluteordifferential.
35

36. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of DP, T and RH
36

37. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of DP, T and RH
T: 18-22 C
RH: 30-60 %
37

38. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of in/out paths for staff/ material (Personnel, Product, Waste, QC
Sample, Material and Equipment Movement Flow)
38

39. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of the main process equipment and utilities (Equipment Arrangement)
39

40. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of the main process equipment and utilities (Equipment Arrangement)
40

41. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of the main process equipment and utilities (Equipment Arrangement)
Anautomatedsystemforbloodsterilitytesting.High-fluorescenttechnology
allowsyoutodetectpositivesamplesfaster.AbottlewithaBDBACTEC™
nutritionalmediumemploysasensorthatrespondstoCO2releasedby
microorganisms.Photodetectorsmeasuretheleveloffluorescence,which
dependsontheamountofCO2emitted.Further,thesemeasurementsare
interpretedbythedeviceinaccordancewiththecriteriaoftheprogram
analyzer.Whenpositiveculturesaredetected,thedeviceimmediately
reportsthiswithlightandsoundsignalsanddisplaysthedataonthe
monitor.
BD BACTEC ™FX
41

42. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of the main process equipment and utilities (Equipment Arrangement)
Automatedmediapreparatorswillautomaticallyprepare,
sterilizeanddispenseliquidorsolidculturemedia
canrangefromhandoperateddispensingsystemsfor
smallerlabs
to'walk-away'systemsforlargerlabs
42

43. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
TheHVACdisciplinesplayacriticalroleinthemicrobiologylab.
Turbulent or Uni-directional airflows
Filter position
Air re-circulation vs. fresh air
Return air systems (positions)
43

44. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
Air flow patterns
Uni-directional / laminar
displacement of dirty air
Turbulent
dilution of dirty air
0,45 m/s
44

45. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
Turbulent Airflow
Induction diffuser
Swirl diffuserPerforated plate diffuser
45

46. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
Unidirectional Airflow
46

47. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
Filtration
AHU
Prefilter
Final filter
21
47

48. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
Filtration
Prefilter
AHU
Main filter
Uni-directional TurbulentTurbulent
1
2 3
48

49. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
Filtration
Level of protection Recommended filtration
Level 1
Primaryfiltersonly(e.g.EN779G4filters)
Level 2
Protectedareasoperatingonrecirculatedorfullfreshair;Primary
plussecondaryfilters(e.g.EN779G4plusF8orF9filters)
Level 3
Productionfacilityoperatingonrecirculatedplusambientair,where
potentialforcross-contaminationexists:Primaryplussecondaryplus
tertiaryfilters(e.g.EN779G4plusF8plusEN1822H13filters)(for
fullfreshairsystem,withoutrecirculation,G4andF8orF9filtersare
acceptable)
49

50. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
Air Distribution
50

51. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Definition of AHU Zonification, Definition of AHU and ECF Filtration
Heating, Ventilation, and Air Conditioning Systems (HVAC)
Air Distribution
51

52. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Basic Design
The Basic Design stage is done from the Conceptual Design, defining all the constructive aspects of the project, its
facilities and equipment. This stage generates the key design documents, which are used as a framework for the
detailed design process. This documents include:
oAHUandECFPositionandPlatformLayout
oTypeofDoorandGlassviewPanel
oServicePanelLayout
oTypeofPassThroughorPassBox
oBaseboardandFloorSlop
oFlooring,WallandCeilingMaterial
oGowningType,WorkingHoursandOccupancyinEachArea
oFireBoxandEmergencyExitPlan,FireAlarmandDetectionSystem
oSupplyandExtractDamperandPlenumType
oDrainLayout(Floor,SinkandEquipment)
oUtilityLayout(DomesticColdandHotWater,Vacuum,Gas(CO2,
N2,..),CompressedAir,PW)
oLightingZonificationandLuxLevel,TypeofIllumination
oSinglePhase,ThreePhase,DataandTelephoneSocket
oAccessControl,CCTV,AudioDistributionandInterlockSystem
oEMS/MonitoringDevicesDPT,TemperatureandHumiditySensor
52

53. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
53
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
1
Planning
2
Designing
3
Conceptual Design
4
Basic Design
5
Detail Design
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021
Detail Design
TheDetailDesignstageproducesthedocumentsrequiredforconstructionbiddingandcontracting,systemand
equipmentpurchase,fabrication,installation,andtesting.Thephaseofengineeringmustprovideacompletedocument
withdescriptivememory,specificationofmaterialsandequipment,functionalspecifications,justificativecalculations,
plans,constructivedetails,conditionofmeasurementsandlistsofequipment'sandcomponents.
Piping,Ducting,Plumbing,Lighting

54. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Selecting and qualifying the highest standard materials and products in the field, offers the best cost/benefit ratio that
fits to the users’ project needs.
Project Site Logistics Plan
Project Quality Control Plan
Budget Estimating
Procurement Plan
Safety Plan
Meeting and Reporting
Schedule Development and Control
Document Planning and Control
Engineering Change Management
54
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

55. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
➢The materials used should be selected to meet the requirements of the installation, and
should take into account the following:
a) the cleanliness class;
b) effects of abrasion and impact;
c) cleaning and disinfection methods and frequencies;
d) chemical/microbiological attack and corrosion.
➢Surface cleanliness and cleanability of materials of construction
➢Fittings in airlocks: Minimum horizontal surfaces
55
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

56. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
➢Ceilings: Ceilings should be sealed, penetration points should be kept minimum.
➢Walls: Materials and surface finishes should meet all general requirements.
•Particular consideration to impact and abrasion. (rubbing strips, protective bars)
•Cover strips or seals between panels should be smooth, with rounded edges
•Use double glazing, with airtight seal, which can enable flush mounting
•Doors should present as few horizontal surfaces as possible, thresholds avoided.
•Consider use of push plates, automatic openings, or appropriate door-swing
➢Floors: Floors or floor coverings should be non-porous, slip-resistant, abrasion resistant, conductive if
necessary.
56
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

57. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
A well planned, documented, and managed engineering approach to start-up and turnover of facility, systems, and
equipment to the End-User that results in a safe and functional environment that meets established design and
stakeholders expectations.
Project Close-out and Turnover
Final Project Report
As built drawing and specification
Training
Inspection and Testing
57
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

58. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
A good design is essential, but it has to be complemented by:
Qualification of air handling systems
Maintenance and periodic re-qualification
Adequate documentation
58
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

59. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
59
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

60. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Test
Filter Leakage
Turbulent / mixed
airflow
Description
Uni-directional
airflow / LAF
Room differential pressure
Airflow velocity / uniformity
Airflow volume / rate
Parallelism
Air flow pattern
2 2
N/A 2, 3
2, 3 Optional
2 2
2 N/A
2 3
1 := As built (ideally used to perform IQ)
2 = At rest (ideally used to perform OQ)
3 = Operational (ideally used to perform PQ)
Recovery time
Room classification (airborne particle)
Temperature, humidity
N/A 2
2 2,3
N/A 2,3
1 := As built (ideally used to perform IQ)
2 = At rest (ideally used to perform OQ)
3 = Operational (ideally used to perform PQ)
60
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

61. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Room classification (airborne particle)
⚫Measurement of airborne particle
concentrations with size 0.5 -5 μm.
⚫A discrete-particle-counting, light-scattering
instrument is used to determine the
concentration of airborne particles.
⚫Prior to testing, verify that all aspects of the
cleanroom and functioning in accordance with
specifications.
–Airflow rate or velocity tests;
–Pressure difference test;
–Containment leakage test;
–Filter leakage test
61
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

62. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Airflow Test
⚫To measure airflow velocity and uniformity, and supply airflow rate
⚫Measurement of velocity distribution is necessary in unidirectional airflow
cleanrooms, and supply airflow rate in non-unidirectional cleanrooms.
⚫Supply airflow rate (air volume supplied to the clean installation per unit of time) can
also be used to determine the air changes.
⚫Airflow rate is measured either downstream of final filters or in air supply ducts; both
methods rely upon measurement of velocity of air passing through a known area.
62
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

63. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Air pressure difference test
⚫Verify the capability of the complete installation to maintain the specified pressure
difference between separate spaces
⚫With all doors closed, the pressure difference between the cleanroom and any
surrounding should be measured and recorded
63
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

64. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Installed filter system leakage test
⚫To confirm that the filter system is properly installed and that leaks have not
developed
⚫Introducing an aerosol challenge upstream of the filters and scanning immediately
downstream of the filters and support frame or by sampling in a downstream duct.
⚫Applied to cleanrooms in “as-built” or in “at-rest” occupational states, and when
commissioning new cleanrooms, or existing installations require re-testing, or after
the final filters have been replaced
⚫Detection of leakage by Scanning / Stationary remeasuring
64
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

65. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Maintenanceisanothercriticalfactorinthecleanroom
facilitiesasitnotonlykeepstheminoperationalcondition
butlengthensitslife.
Cleanroomarquitecture:repaircrushedorbrokenpanels
andceilings;repairandreplacementofdamagedsealed
joints;installationofprotectionpanels,roofreinforcements,
replacementandrepairofdifferentelementsindoorsas
handles,locks,latches;adjustmentsandtroubleshootingof
pressurelossesandleaksbyinstallingweather-stripping;
replacementandsealingofsanitaryprofilesetc.
65
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

66. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral Maintenance
Routinemonitoringprogramaspartofqualityassurance
Additionalmonitoringandtriggers
1.Shutdown
2.Replacement of filter elements
3.Maintenance of air handling systems
4.Exceeding of established limitsSchedule of Tests to Demonstrate Continuing Compliance
Test Parameter Class Maximum Time
Interval
Test Procedure
A, B
<= ISO 5
6 Months ISO 14644 -1 Annex AParticle Count Test
C, D
> ISO 5
12 Months ISO 14644 -1 Annex A
Air Pressure DifferenceAll Classes 12 Months ISO 14644 -1 Annex B5
Air Flow All Classes 12 Months ISO 14644 -1 Annex B4
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Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

67. Introduction
Cleanroom Facility
Design Object
Engineering Design Process
Conceptual, Basic and
Detail Design
Construction
Materials of Construction &
Surface Finishes
Commissioning
Start-Up and Turnover of
Facilities, Systems and Equipment
4
Testing/Qualification
Cleanroom and HVAC
System Qualification
Maintenance
Plan of Integral MaintenanceSchedule of Additional Optional Tests

Test Parameter

Class
Maximum Time
Interval
Test Procedure
Installed Filter Leakage All Classes
24 Months

ISO 14644-1 Annex B6
Containment Leakage All Classes
24 Months

ISO 14644-1 Annex B4
Recovery

All Classes
24 Months

ISO 14644-1 Annex B13
Air Flow Visualisation

All Classes
24 Months

ISO 14644-1 Annex B7

67
Part I: Microbiology Laboratory Design Principles, Mohammad M. Sepahi, PhD December 2021

68. Thank You
Questions and Comments?
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December 2021