ISO INTERNATIONAL STANDARD 21882 First edition 2019-10 Sterile packaged ready for filling glass vials Flacons en verre preremplissables sous emballage sterile Reference number IS0 21882:2019(E) ISO @IS0 2019 IS0 21882:2019(E) COPYRIGHTPROTECTEDDOCUMENT IS02019 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting below or Iso's member body in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+4122749 0111 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 21882:2019(E) Contents Page Foreword ..iv Introduction. .. 1 Scope. 2 Normative references 3 Terms and definitions ..2 4 Qualitysystem .2 4.1 General. 4.2 Testing. .3 5 Processdescriptionandrequirements .3 5.1 Washing. .3 5.2 Drying. .3 5.3 Packaging. .3 5.4 Sterilization ..3 6 Requirementsforglassware ..4 6.1 General .4 6.2 Material ..4 6.3 Dimensions 4 6.4 Particles. .4 6.4.1 Visible particles. 4 6.4.2 Sub-visible particles .4 6.5 Bacterial endotoxin level .5 Requirements for packaging system 7 .5 7.1 General .5 7.2 Nest and tub configuration .6 7.3 Tray configuration. .6 7.4 Nest. ..6 7.5 Tub and tray .7 .1 7.6 Insertliner 7.7 Sealing lid 7 7.8 Protective bag 7.9 Informationtobeprovided bythemanufacturer. 8 ..8 Marking of the tub or tray 9 Labelling. .9 AnnexA (informative)Design oftub ..10 AnnexB (informative)Designof nest .11 AnnexC (informative)Design oftray .12 AnnexD (informative)Schematic illustrations ofexamples for the orientation of tubs or ..13 trays withintheprotective bag. Annex E (informative) Sample preparationfor endotoxinand particulate determination ..16 AnnexF (informative) Packagingconfiguration .19 Bibliography .20 @ IS0 2019 - All rights reserved ili