Chapter one Introduction |
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The background to isolation technology |
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Isolation technology - a definition |
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2 | (2) |
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Isolation technology versus barrier technology |
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4 | (1) |
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The aim of isolation technology |
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Improvement in product quality |
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6 | (1) |
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7 | (2) |
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9 | (1) |
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9 | (1) |
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10 | (1) |
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Some typical applications of isolation technology |
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10 | (10) |
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10 | (1) |
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11 | (2) |
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13 | (1) |
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14 | (2) |
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Surgical and other miscellaneous uses of isolation technology |
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18 | (2) |
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What isolation technology is not: a panacea |
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20 | (1) |
Chapter two An introduction to the technology |
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21 | (32) |
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21 | (5) |
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21 | (2) |
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23 | (1) |
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24 | (1) |
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24 | (1) |
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24 | (2) |
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26 | (1) |
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Air handling in isolators |
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26 | (19) |
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27 | (8) |
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35 | (2) |
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37 | (4) |
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37 | (1) |
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38 | (2) |
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40 | (1) |
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41 | (2) |
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Calculations for isolator air handling systems |
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43 | (2) |
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Handling the work in isolators |
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45 | (8) |
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45 | (4) |
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49 | (1) |
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50 | (1) |
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50 | (3) |
Chapter three A review of transfer methods |
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53 | (34) |
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54 | (1) |
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54 | (4) |
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58 | (2) |
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60 | (3) |
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63 | (4) |
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64 | (3) |
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Operational considerations |
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67 | (15) |
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67 | (1) |
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67 | (1) |
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67 | (1) |
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68 | (1) |
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68 | (4) |
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69 | (1) |
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69 | (1) |
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69 | (1) |
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69 | (2) |
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71 | (1) |
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72 | (1) |
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72 | (1) |
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72 | (3) |
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A further type of RTP: the split butterfly port |
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75 | (1) |
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75 | (3) |
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78 | (2) |
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80 | (2) |
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82 | (5) |
Chapter four Further design considerations |
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87 | (8) |
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87 | (3) |
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Simple, turbulent flow isolators |
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87 | (1) |
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Double-fan turbulent flow isolators |
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88 | (2) |
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Simple, unidirectional flow isolators |
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90 | (1) |
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Recirculating unidirectional isolators |
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90 | (1) |
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Temperature and relative humidity |
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90 | (1) |
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91 | (1) |
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91 | (1) |
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92 | (1) |
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HEPA filter pressure drop |
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92 | (1) |
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Temperature and relative humidity |
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93 | (1) |
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93 | (1) |
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94 | (1) |
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94 | (1) |
Chapter five How to draw up a design specification |
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95 | (18) |
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User requirement specification (URS) |
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95 | (2) |
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97 | (1) |
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97 | (3) |
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Workspace ergonomics and handling |
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100 | (1) |
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101 | (1) |
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Major equipment interface |
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102 | (1) |
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Positive pressure or negative pressure: the cytotoxic dilemma |
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103 | (2) |
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Turbulent airflow or unidirectional downflow |
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105 | (1) |
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106 | (1) |
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The isolator room environment for sterile operations |
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107 | (2) |
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Control and instrumentation |
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109 | (1) |
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Sterilisation and decontamination |
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110 | (1) |
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Standard versus special isolator design |
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110 | (3) |
Chapter six Seeing the project through |
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113 | (24) |
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Liaison with your designer and supplier |
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114 | (1) |
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Further project development |
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115 | (4) |
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115 | (1) |
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115 | (3) |
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DQ - design qualification |
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115 | (1) |
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IQ - installation qualification |
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115 | (1) |
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OQ - operational qualification |
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116 | (2) |
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PQ - performance qualification |
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118 | (1) |
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Some further points about qualification protocols |
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118 | (1) |
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119 | (1) |
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Preengineering studies, models, and mockups |
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120 | (1) |
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Terms, payment structures, and guarantees |
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121 | (1) |
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121 | (3) |
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122 | (1) |
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123 | (1) |
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124 | (5) |
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124 | (1) |
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124 | (1) |
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125 | (1) |
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126 | (3) |
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128 | (1) |
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128 | (1) |
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129 | (1) |
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Expression of pressure decay test results |
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129 | (1) |
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129 | (1) |
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Percentage volume loss per hour |
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129 | (1) |
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Volume loss per second (or per hour) |
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130 | (1) |
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130 | (1) |
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Classification by leak rate |
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130 | (1) |
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Further discussion of leak testing: the distributed leak test |
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130 | (1) |
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Testing gloves and sleeves |
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131 | (1) |
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Further leakage considerations |
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132 | (1) |
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When should leak testing be carried out? |
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132 | (1) |
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132 | (1) |
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133 | (1) |
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134 | (2) |
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134 | (1) |
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135 | (1) |
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135 | (1) |
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135 | (1) |
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135 | (1) |
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Any other relevant parameters |
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135 | (1) |
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136 | (1) |
Chapter seven Cleaning up: sterilisation and decontamination |
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137 | (26) |
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Sterilisation - manual wet processes |
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138 | (1) |
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139 | (1) |
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139 | (1) |
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139 | (1) |
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140 | (18) |
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Recent developments in gas-phase sterilisation |
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140 | (2) |
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142 | (2) |
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144 | (6) |
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150 | (1) |
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151 | (5) |
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HPV as a sterilising agent |
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156 | (1) |
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Other gas-phase sterilising agents |
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157 | (4) |
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158 | (1) |
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158 | (1) |
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Validating the sterilisation process |
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158 | (1) |
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159 | (2) |
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Decontamination in toxic and pathogenic applications |
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161 | (2) |
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Chemical decontamination: cytotoxics |
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161 | (1) |
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Chemical decontamination: unknown hazards |
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161 | (1) |
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Biological decontamination: pathogens and recombinant DNA |
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161 | (2) |
Chapter eight Running the operation |
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163 | (10) |
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164 | (1) |
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165 | (2) |
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165 | (1) |
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165 | (1) |
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Particle counting during media filling trials |
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166 | (1) |
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Stability of the isolator parameters during production |
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166 | (1) |
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166 | (1) |
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Mechanical and electronic reliability (GAMP) |
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166 | (1) |
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Microbiological validation |
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167 | (3) |
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167 | (1) |
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The sterilisation process |
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167 | (1) |
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167 | (1) |
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168 | (1) |
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Viable particle counting during production |
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168 | (2) |
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170 | (1) |
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Standard operating procedures |
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170 | (1) |
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Planned maintenance and servicing |
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171 | (1) |
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171 | (1) |
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172 | (1) |
Chapter nine Regulatory affairs |
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173 | (10) |
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The MHRA (formerly the MCA) |
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173 | (3) |
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The practical considerations |
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174 | (2) |
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176 | (3) |
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Further regulatory comment |
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179 | (4) |
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Standards and guidelines for isolators |
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179 | (4) |
Chapter ten Case studies |
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183 | (22) |
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Aventis (previously Rhone-Poulenc Rorer), Holmes Chapel, Cheshire, UK |
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183 | (3) |
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183 | (1) |
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184 | (1) |
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185 | (1) |
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185 | (1) |
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Dabur Oncology, Bordon, Hampshire, UK |
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186 | (19) |
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186 | (4) |
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Positive- or negative-pressure isolators? |
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190 | (1) |
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General layout and cleanrooms |
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190 | (2) |
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192 | (1) |
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192 | (1) |
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Specific isolator designs detail |
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193 | (2) |
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193 | (1) |
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194 | (1) |
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194 | (1) |
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194 | (1) |
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195 | (1) |
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195 | (1) |
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195 | (1) |
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196 | (1) |
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Review in the light of experience |
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196 | (9) |
References |
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205 | (4) |
Glossary |
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209 | (4) |
Index |
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213 | |