{"id":198039,"date":"2024-10-19T12:36:29","date_gmt":"2024-10-19T12:36:29","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-13408-3-2006-ra-2015\/"},"modified":"2024-10-25T05:09:43","modified_gmt":"2024-10-25T05:09:43","slug":"aami-13408-3-2006-ra-2015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-13408-3-2006-ra-2015\/","title":{"rendered":"AAMI 13408 3 2006 RA 2015"},"content":{"rendered":"<p>Specifies requirements for and offers guidance on equipment, processes, programs and procedures for the control and validation of lyophilization as an aseptic process. It does not address the physical\/chemical objectives of a lyophilization process.<\/p>\n<h4>PDF Catalog<\/h4>\n<table border=\"1px\" class=\"des-table\">\n<tr>\n<th>PDF Pages<\/th>\n<th>PDF Title<\/th>\n<\/tr>\n<tr>\n<td><b>1<b><\/td>\n<td>ANSI\/AAMI\/ISO 13408-3: 2006\/(R)2015, Aseptic processing of health care products \u2014 Part 3: Lyophilization  <\/td>\n<\/tr>\n<tr>\n<td><b>2<b><\/td>\n<td>Objectives and uses of AAMI standards and recommended practices  <\/td>\n<\/tr>\n<tr>\n<td><b>3<b><\/td>\n<td>Title page  <\/td>\n<\/tr>\n<tr>\n<td><b>4<b><\/td>\n<td>AAMI Standard <br \/> Copyright information  <\/td>\n<\/tr>\n<tr>\n<td><b>5<b><\/td>\n<td>Contents  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>Glossary of equivalent standards  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>Committee representation  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>Background of ANSI\/AAMI adoption of ISO 13408-3:2006  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>1 Scope <br \/> 2 Normative references <br \/> 3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>4 Quality system elements <br \/> 4.1 General <br \/> 4.2 Management responsibility <br \/> 4.3 Design control <br \/> 4.4 Measuring instruments and\/or measuring systems <br \/> 5 Product definition  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>6 Process definitions <br \/> 7 User requirements <br \/> 7.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>7.2 Equipment characterization <br \/> 7.3 Product handling <br \/> 7.3.1 Transport to, and loading of, the lyophilizer  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>7.3.2 Unloading the lyophilizer <br \/> 7.4 Microbiological and particulate environmental monitoring <br \/> 7.5 Cleaning and sterilization <br \/> 7.5.1 Cleaning-in-place (CIP) <br \/> 7.5.2 Manual cleaning <br \/> 7.5.3 Sterilization in place (SIP)  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>7.6 Vent filter system <br \/> 7.7 Lyophilizer leak test <br \/> 8 Validation <br \/> 8.1 General <br \/> 8.2 Design qualification <br \/> 8.3 Installation qualification <br \/> 8.3.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>8.3.2 Installation <br \/> 8.3.3 Computer and software qualification <br \/> 8.3.4 Alarm systems <br \/> 8.4 Operational qualification <br \/> 8.4.1 General <br \/> 8.4.2 Leak test <br \/> 8.4.3 Thermal control system(s)  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>8.4.4 Vacuum system <br \/> 8.4.5 Condenser refrigeration <br \/> 8.4.6 Defrosting <br \/> 8.4.7 Lyophilization cycle <br \/> 8.4.8 CIP cycle <br \/> 8.4.9 SIP cycle <br \/> 8.4.10 Stoppering seating system(s) <br \/> 8.4.11 Shelf temperature distribution  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>8.5 Performance qualification <br \/> 8.5.1 General <br \/> 8.5.2 Lyophilization <br \/> 8.5.3 SIP <br \/> 8.6 Process validation <br \/> 8.6.1 General <br \/> 8.6.2 Cleaning validation <br \/> 8.6.3 Process simulations  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>8.6.4 Product validation <br \/> 8.7 Review and approval of validation <br \/> 9 Routine monitoring and control <br \/> 9.1 General <br \/> 9.2 Operator training  <\/td>\n<\/tr>\n<tr>\n<td><b>23<b><\/td>\n<td>9.3 Standard operating procedures <br \/> 9.4 Requalification <br \/> 9.5 Maintenance of equipment <br \/> 9.6 Change control  <\/td>\n<\/tr>\n<tr>\n<td><b>24<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>ANSI\/AAMI\/ISO 13408-3:2006\/(R)2015 &#8211; Aseptic processing of health care products-Part 3: Lyophilization<\/b><\/p>\n<table class=\"shortdes-table\" style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/aami\/\"><b>AAMI<\/b><\/a><\/td>\n<td>2006<\/td>\n<td>24<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198040,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198039","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198039","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198040"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198039"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198039"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198039"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}