Inspection Technical Guides.docx

Inspection Technical Guides.docx

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InspectionTechnicalGuides

DEPTOFHEALTHANDHUMANSERVICES

Date:

11/30/87

Number:

None

PUBLICHEALTHSERVICE

FOODANDDRUGADMINISTRATION

RelatedProgramAreas:

ORO/ETSB（HFC-133）AllPrograms

SUBJECT:

TABLEOFCONTENTS

ThisissuancehasbeenwrittentoserveasaTableofContentsforpreceedingITGissues.NewITG'sshouldbeaddedastheyarereceived.TheTableofContentswillberevisedandredistributedasnecessary.

INSPECTIONTECHNICALGUIDES

CONTENTS

ThisissuancehasbeenwrittentoserveasaTableofContentsforpreceedingITGissues.NewITG'sshouldbeaddedastheyarereceived.TheTableofContentswillberevisedandredistributedasnecessary.

No.

Subject

RelatedProgramAreas

DateIssued

1.

IntroductoryIssue

AllPrograms

1/20/72

2.

SteamGenerationinCanneries

FoodCanneries

2/11/72

3.

SteamDistributionforRetort

VentinginFoodCanneries

FoodCanneries

3/03/72

4.

NewEquipmentKenics

StaticMixers

Food,DrugandCosmetic

3/20/72

5.

EthyleneOxide

Sterilization1.

CalculationofInitial

GasConcentration

Drugs,SterileDevices

6/09/72

6.

LeakTestingSealedAmpuls

ofParenteralSolutions

Drugs,HumanandVeterinaryInjectableVitamins

4/28/72

7.

SterilizingSymbols

（D,Z,F）

LowAcidCannedFoods

1/09/72

8.

"PackageUnit"ItalianFlourMills

CerealFlours&RelatedProducts

12/14/72

9.

Polariscope

SterilePackaging-Foods,Drugs,Devices,HardenedLenses

5/21/73

10.

Diathermy

MedicalDevices

5/21/73

11.

SteamPressurefor

RetortsandAutoclaves

SterileDrugsandDevicesLowAcidCannedFoods,Biologics

6/29/73

12.

Stroboscope

Food,Drug,Device,ManufactureandPackaging

8/08/73

13.

FieldSubmissionof

Articles

AllPrograms

9/05/73

（8/03/84Revised）

14.

ThermocoupleSurface

Pyrometers

FoodCanneries

12/20/73

15.

CommonValvesUsedin

ProcessFluidSystems

SterileDrugs,Devices,LowAcidCannedFoodsandBiologics

1/15/74

16.

A.T.I.SteamActivated

HeatSensitiveIndicators

Food,Drugs,MedicalDevices

3/08/74

17.

NewSourceofLeadand

OtherContamination

VariousFoodsandDrugs

6/18/74

18.

UltrasoundintheFood,

Drug,andDeviceIndustries

Food,Drugs,andMedicalDevices

3/03/75

19.

ScreeningElectronic

Components

MedicalDevices

4/20/75

20.

HermeticallySealed

ElectronicComponent

LeakDetection

MedicalDevices

7/18/75

21.

NoiseControlMufflers

forBleedersonRetortsandSterilizers

Food,Drugs

9/15/75

22.

GroundFaultCircuit

Interrupter

AllPrograms,PersonnelSafety

3/05/76

23.

TheComputerinFDA

RegulatedIndustries

Foods,Drugs,andMedicalDevices

5/21/76

24.

AirVelocityMeters

SterileDrugsandDevices,FoodsandCosmetics

7/30/76

25.

EthyleneOxide

Sterilization2.GraphicalAidtoDetermineGasConcentration

SterileDevices,Drugs

9/01/76

26.

EvaluationofProductionCleaningProcessesforElectronicMedicalDevices-Part1,Contaminants

MedicalDevices

1/07/77

27.

EvaluationofProduction

CleaningProcessesforElectronicMedicalDevices-PartII,CleaningSolvents

MedicalDevices

1/07/77

28.

EvaluationofProduction

CleaningProcessesforElectronicMedicalDevices-PartIII,Methods

MedicalDevices

1/07/77

29.

TheComputerinFDA

RegulatedIndustries-PartIIComputerHardware

AllPrograms

9/22/77

30.

TheNationisGoingMetric

（rescinded）

AllPrograms

12/02/77

31.

ElectronicComponents-

Resistors

MedicalDevices,RadiologicalHealth

1/16/78

32.

Pyrogens,StillaDanger

Parenterals,Biologicals,Devices,Drugs

1/12/79

33.

UseoftheTexasInstruments

Model59ProgrammableCalculatorintheEnforcementoftheDiagnosticX-rayPerformanceStandard

X-RayFieldTesting

7/12/79

34.

HeatExchangerstoAvoid

Contamination

Drugs,DiagnosticProductsBiologics

7/31/79

35.

ReliabilityofManufactured

Products

MedicalDevice,RadiologicalHealthProducts

9/26/80

36.

ReverseOsmosis

Drugs,MedicalDevicesandDiagnosticProducts

10/21/80

37.

TemperatureSensorsin

theRegulatedIndustry

Foods,Drugs,Biologics,MedicalDevicesandDiagnosticProducts

1/7/83

38.

IndustrialApplicationsof

NewBiochemicalTechnolgy

AllPrograms

8/1/83

39.

WaterActivity（a{{w}}）inFoods

Foods

4/16/84

40.

BacterialEndotoxins/Pyrogens

DrugsandDevices

3/20/85

41.

ExpirationDatingand

StabilityTestingforHumanDrugProducts

Drugs

10/18/85

42.

TinWhiskers-Problems,

Causes,andSolutions

MedicalDevices

3/14/86

43.

LyophilizationofParenterals

Drugs,Biologics,Diagnostics

4/18/86

44.

RadiationProtectionTerminology

Foods

5/15/86

45.

CircularTemperatureRecording

ChartMeasurements

AllPrograms

2/20/87

46.

WaterforPharmaceuticalUse

Drugs,Biologics,MedicalDevices

12/31/86

47.

MeasurementofRelativeHumidity

intheETOProcess

DrugsandMedicalDevices

4/30/87

48.

MicrobiologicalContamination

ofEquipmentGasketswithProductContact

AllPrograms

12/31/86

49.

StockRotomat

Foods

5/30/87

50.

Capacitor

MedicalDevices/RadiologicalHealth

10/23/87

51.

ElectronicRelays

MedicalDevices/RadiologicalHealth

11/10/87

52.

VoiceRecognitionSystems

GLPandDevices

11/10/87

moveanddestroytableofcontentsdate4/30/87.

IntroductoryIssue

[TableofContents][NextChapter]

DEPT.OFHEALTH,EDUCATION,ANDWELFAREPUBLICHEALTHSERVICE

FOODANDDRUGADMINISTRATION

*ORA/ORO/DEIO/IB*

Date:

2/4/72Number:

1

RelatedProgramAreas:

AllPrograms

________________________________________________________

ITGSUBJECT:

INTRODUCTORYISSUE

ThisissuancelaunchestheInspectorsTechnicalGuide,commonlyknownas"ITG".ItisintendedasamediumformakingallFDAInspectorsawareofselectedtechnicalinformationnotpreviouslyavailableonabroadscale.ContentoftheITGwilldifferfromInspectorsManualmaterialinthattheITGwillnotnormallyexpressoperationaldirectives.ItmaybecomplementaryandadddepthtoManualinstructions,however,itsusewilldependuponInspectors'orDistricts'judgment.Theintervalofpublicationwillbe"asneeded".ResponsibilityforITGissuancerestswiththe*ORA/ORO/DEIO/HFC-130*.DistributionistobesufficientforeachInspectorandTechnician,pluscopiesforinterestedDistrictandHeadquartersunits.

DistrictsshouldarrangetomaintainacompletesetofITG'sintheInspectors'LibraryandeachResidentPost.Weregretbeingunabletosupplybindersaswasoriginallyintended.（Thewholematterof"Manualproliferation"ispresentlyunderstudy.）Wesuggestyouusestandardone-inch,three-ringbinders.IndexandTableofContentsfortheretentionsetswillbeprovidedandup-datedasnecessary.

PresentplansforleadingITGissuesincludethefollowingtopics:

1.Boilerplantinspectionsinfoodcanneries

2.Steamdistributiontoretorts

3.Steampressureregulators

4."Cook-Chex"retortindicators

5."Polariscope"

6."Strobotac"

7."Kenics"StaticBlender

8.Ethyleneoxidesterilization

a.gasconcentrations

b.operationalfactors

c.residualtoxicity

d.biologicalindicators

SuggestionsforotherITGtopicsmaybesubmittedtoHFC-130byanyDistrictatanytime.Ideally,topicsshouldbesuitablefortextswithmaximumlengthoftwosingle-spacedpages,althoughaseriesofissuesmaybeusedtohandlelongertopics.Wehope,onalong-rangebasis,tosolicitfinishedITGarticlesfromInspectorsinordertopromoteuseofthespecialexpertisepresentlyavailableinmanyproblemareas.GroundrulesforFieldsubmissionswillbepublishedatalaterdate,includingamechanismforcoordinationtopreventduplicationofeffortonthesametopics.AnyquestionsregardingtheITGshouldbeaddressedto*DEIO/InvestigationsBranchon（301）443-3340.*

SteamGenerationinCanneries

[PreviousChapter][TableofContents][NextChapter]

DEPT.OFHEALTH,EDUCATION,AND

WELFAREPUBLICHEALTHSERVICE

FOODANDDRUGADMINISTRATION

*ORA/ORO/DEIO/IB*

Date:

2/11/72Number:

2

RelatedProgramAreas:

FoodCanneries

___________________________________________________________________

ITGSUBJECT:

STEAMGENERATIONINCANNERIES

Followingisabriefdescriptionofsteamgeneratingequipmentandoperationstypicallyfoundinfoodcanneries,andsomepointstoconsiderinitsevaluation.Smallcanneriesaremostfrequentlyfoundwithimproperconditionsandmethodsofoperation,andthisdiscussionisdirectedtowardsuchsmallcanneries,usingbatch-typeretortsforcooking.

Duringaninspectionoftheboiler-roomorpowerplant,oneormoreboilersmaybeobservedtobeoperating.Twotypesofboilersmaybefound,fire-tubeandwater-tubeboilers.Smallerboilersofthe"packaged"boilertypearealmostalwaysfire-tubeboilers,andinphysicalappearanceareunusuallylongandrelativelylow.Suchboilersareoftenreferredtoas"scotch-marine"or"marine"typeboilers.Largerboilerswhichhavebeenconstructedinplacearealmostalwayswater-tubeboilers,andareusuallynearlysquareandquitehigh,sometimes4or5storiesinheight.

Itisdesirabletodeterminethenumberofboilers,andthetype,steam-generatingcapacity（orsize）,andmethodoffiringforeach.Insomeinstances,ametalplatefixedtotheboilerwillgivethenominal（rated）capacity,butmanyboilermanufacturersdonotdothis.Insuchcases,thisinformationmaybeobtainedfromthefireman,boileroperator,powerplantengineerorplantmanager.Theratedcapacitymaybegivenineitheroftwoterms;horsepower（hp）orpoundsofsteamperhour.Insmallplants,horsepoweristhemostacceptedandunderstoodterm.Ifboilercapacityisgiveninpoundsofsteampe