Freeze-drying of pharmaceutical and food products

274 Pages·2010·13.387 MB·English

by  Tse-Chao Hua

Woodhead Publishing SeriesinFoodScience,TechnologyandNutrition:
Number198
Freeze-drying of
pharmaceutical and
food products
Tse-Chao Hua, Bao-Lin Liu and Hua Zhang
eRePress
Boca Raton Boston NewYorkWashington,D. e.
Wo
0 D HE AD PUB LIS H I N G LIM I TED
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Contents
Woodhead PublishingSeries in Food Science,
Technology and Nutrition vii
Preface xv
1 Introduction 1
1.1 Briefhistoryoffreeze-dryingtechnology I
1.2 Basicprocessesoffreeze-drying 3
1.3 Protectingagentsoffreeze-drying 8
1.4 Freeze-dryingsystemconstitution 10
1.5 Applicationsoffreeze-dryingtechnology 13
2 FundamentalsofFreezeDrying 18
2.1 Propertiesofwaterandaqueoussolution 18
2.2 Freezingprocess 42
2.3 Sublimationdryingprocess 48
2.4 Desorptiondryingprocess 53
2.5 Storageofthe freeze-dryingproducts 54
3 Heat-MassTransferAnalysesandModelingofthe
DryingProcess 68
3.1 Restrictionofheat-masstransferanditsrelativeproperties 68
3.2 Characteristicsofdryingprocessindifferentheatingforms 74
iv Contents
3.3 Analyses ofmasstransfer control andheattransfer control in
sublimationdrying 80
3.4 Mathematical model andcomputational analyses ofprimary
and secondary drying stages 92
3.5 Thermal properties offreezedriedmaterial... 105
3.6 Discussion onmathematical model fordrying process 108
4 EquipmentforFreeze-drying III
4.1 Vacuumrequirementoffreeze-drying III
4.2 Vacuummeasurementinfreeze-drying 113
4.3 Vacuumpump forfreeze-drying 116
4.4 Refrigerationsystem andwater vapor condenser
infreeze-drying 121
4.5 Small-scale freeze-drying equipment forlaboratory use 125
4.6 Intermediate experimental freeze-drying equipment 127
4.7 Intermittentandcontinuous freeze-drying equipment... 129
4.8 Food freeze-drying equipment 131
4.9 Pharmaceutical freeze-drying equipment 135
S Freezing-dryingofFood 141
5.1 Thecharacteristicsoffreeze-dried food 141
5.2 Techniques forfoodfreeze-drying 142
5.3 Examples offoodfreeze-drying 150
5.4 Hazard analysis andcritical control point for
freeze-drying offood 156
5.5 Application ofHACCPinfood freeze-drying 163
6 ProtectiveAgentsandAdditivesforFreeze-drying
ofPharmaceuticalProducts 170
6.1 Sugars/polyols-typeprotective agents 170
6.2 Polymer-type protective agents 173
6.3 Surfactants andamino acid-type protective agents
andother additives 175
6.4 Formula issues infreeze-dried products 180
6.5 Examples offormulas 183
Contents v
7 FreezeDryingofPharmaceuticals 187
7.1 Basic issuesforpharmaceuticalfreeze-drying 187
7.2 Freeze-dryingofproteinandhormone 193
7.3 Freezedryingoffibrinogen 195
7,4 Freeze-dryingofliposome 202
7.5 Freeze-dryingofwater-solubleandfat-soluble
liposomepharmaceuticals 210
8 Disinfection, SterilizationandValidation 216
8.1 Disinfectionandsterilization 216
8.2 Validation 222
8.3 Cleaning-in-place,sterilization-in-placeandvalidation 225
8,4 Processvalidationoffreeze-drying 227
8.5 Validationoftechnicalprocessandtheevaluationofvalidation..233
8.6 Dailymonitoring,revalidationandretrospectivevalidation........240
References 242
Index 250

Woodhead Publishing Series in Food
Science, Technology and Nutrition
1 ChiDedfoods:acomprehensiveguide Editedby C Dennisand M.Stringer
2 Yoghurt:scienceand technologyA. Y Tamime and R K. Robinson
3 Food procesgngtechnology:principlesand practiceP.J.Fellows
4 Bender's dictionary ofnutritionand food technologySixthedition
D.A. Bender
5 Detenmnationofveterinaryresidues in food EditedbyN.T.Crosby
6 Food contaminants: sources andsnrveiUanceEditedby C Creaserand
R Purchase
7 Nitrates andnitritesin food andwater Editedby M.1 Hill
8 Pesticidechemistry andbioscience:the food-environmentchallenge Edited
by G.T.BrooksandT.Roberts
9 Pesticides:developments,impacts and controls Editedby G.A. Best and
A. D.Ruthven '
10 Dietary 6bre:chemical andbiololPcai aspeas Editedby D.A. T.Southgate,
K w:Waldron, I. T.Johnson and G.R Fenwick
11 Vitamins and mineralsin healthand nntdtion M.Tolonen
12 Technologyofbiscoils,crackenand cookiesSecond edition D.Manley
13 IDstrnmentationandsensonfor the food indnstry Editedby
E.Kress-Rogers
14 Food and cancer prevention:chemical andbiologicalaspects Editedby
K w:Waldron, I. T.Johnson and G.R Fenwick
15 Food coUoids:proteins,Upidsand polysaccharides Editedby E.Dickinson
and B.Bergenstahl
viii Freeze-dryingofpharmaceuticaland foodproducts
16 Food emulsions and foams Edited by E.Dickinson
17 Maillard reactions inchemistry,food and health Edited by T.P. Labuza,
V.Monnier,J.Baynes and1.O'Brien
18 TheMaillard reactionin foods and medidne Edited by1.O'Brien,
H. E.Nursten, M.J. CrabbeandJ.M.Ames
19 Encapsulationand controlledrelease Edited by D.R Karsaand
R.A. Stephenson
20 Flavours and fra81'ances Edited byA.D.Swift
21 Feta and relatedcheeses Edited byA. Y.Tamime and R K. Robinson
22 Biochemistryofmilk products Edited byA. T.Andrews andJ.R.Varley
23 Physical properties offoods and food processingsystemsM.J.Lewis
24 Foodirradiation:a referenceguide V.M.Wilkinson andG.Gould
25 Kent's technology ofcereals:anintroduction for studentsoffood sdeace
and agriculture FourtheditionN. L.Kent andA.D.Evers
26 Biosensors for food analysisEdited byA. 0.Scott
2J Separation processes in thefoodand biotechnologyindustries:prindples
s:
and appUcations EditedbyA. Grandison and M.J.Lewis
28 Handbookofindices offood qualit)' and authentidty R S: Singhal,
P. K Kulkarni andD.V.Rege
29 Prindplesand practices for the safe processingoffoods D.A. Shapton and
N.F.Shapton
30 Biscuit,cookieand crackermanufacturingmanualsVolume1:ingredients
D.Manley
31 Biscuit,cookieand crackermanUfac.1uringmanualsVolume2:biscuit
doughs D.Manley
32 Biscuit;cookieand crackermanufacturingmanualsVolume 3:biscuit dough
piece forming D.Manley
33 Biscuit,cookieand crackermanufacturingmanualsVolume4:bakingand
cooling ofbiscuitsD.Manley
34 Biscuit,cookieand crackermanufacturingmanualsVolumeS:secondary
processing in biscuit manufactudngD.Manley
35 Biscuit,cookieand crackermanufacturingmanualsVolume 6:biscuit
packagingand storageD.Manley
36 PracticaldehydratioD SecoDdedition M. Greensmith
37 Lawrie'smeatsdenceSixthedition R A. Lawrie
38 Yoghurt:sdenceaDdtechnologySecoBdeditiODA Y.Tamime and
R K. Robinson
39 Newingredientsin food processiDIr-biochemistryand agrieultureG.Linden
and D. Lorient
40 Benders'dictionaryofnutritionand food technologySeventhedition
D.A. BenderandA. E.Bender
41 Technology ofbiscuits,crackersand cookiesThirdeditionD.Manley
42 Food processingtecllnology:prindplesaDdpracticeSecond editiOD
P. J.Fellows
Woodhead Publishing Series in Food Science, Technology and Nutrition ix
43 Managing frozen foods Edited by C J.Kennedy
44 Handbookofhydrocolloids Edited by G.0. Phillips and P.A. Williams
45 Food labellingEditedby J. R. Blanchfield
46 Cereal biotechnology Editedby P. C Morris andJ.H. Bryce
47 Food intoleranceandthe food industry Edited by T. Dean
48 The stability and shelflife offood Editedby D.Kllcast and P. Subramaniam
49 Functional foods: concept to productEditedby G.R. Gibson and
C M.Williams
50 ChiDedfoods:acomprehensiveguide Secondedition Editedby M.Stringer
and C.Dennis
51 HACCPin the meat industry Edited by M.Brown
52 Biscuit,crackerand cookierecipes for the food industryD.Manley
53 Cereals processing technology Edited by G.Owens
54 Baking problems solved S P. Cauvain and L.S Young
55 Thermal technologiesinfood processing EditedbyP. Richardson
56 Frying:improvingquality EditedbyJ.B.Rossell
57 Food chemical safety Volume 1:contaminants Editedby D.Watson
58 Making the most ofHACCP: learning fromothers' experience Edited by
T.Mayes and S Mortimore
59 Food process modellingEditedby L.M. M. Tljskens,M. L.A. T. M. Hertog
and B.M.Nicola!"
60 EU food law:a practicalguide Edited by K. Goodburn
61 Extnsioncooking: technologiesand applications Edited by R. Guy
62 Auditingin the food industry:fromsafety and quality to environmental and
other audits Editedby M. Dillon andC Griffith
63 Handbookofherbsandspices Volume 1Editedby K V.Peter
64 Food productdevelopment:muinisingsuccess M. Earle,R. Earleand
A Anderson
65 Instnmentation andsensorsforthe food industrySecond edition Editedby
E.Kress-Rogers and C J.B.Brimelow
66 Food chemical safetyVolnme2:additives Editedby D.Watson
67 Fraitand vegetablebiotechnology EditedbyV.Valpuesta
68 Foodbomepathogens: hazards,riskanalysis andcontrol Editedby
C delY. BlackburnandP.J.McClure
69 Meat refrigerationS J.JamesandC James
70 LockhartandWiseman's crophnsbandryEighth edition H.J.S.Finch,
A M. SamuelandG.P.F.Lane
71 Safety and quality issues infishprocessingEditedbyH.A Bremner
72 Minimal proceslingtechnologiesin the food industries Edited by T. Ohlsson
and N.Bengtsson
73 Fraitand vegetableprocesling:improvingquality Edited by lY.Jongen
74 Thenutrition handbookforfood processors Editedby C J.K Henry and
C Chapman