DIN ISO 8536-6:2017
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)

Standard No.

DIN ISO 8536-6:2017

Release Date

2017

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN ISO 8536-6 E:2017-04

Latest

DIN ISO 8536-6:2017-09

Replace

DIN ISO 8536-6:2012

Scope

This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. Freeze drying closures can pick up water during shipping, storage, washing and steam sterilization cycles, which is difficult to remove in a subsequent drying cycle. As a consequence, the freeze drying closures are usually loaded with residual moisture. Depending upon the mass of the freeze-dried product and the degree of its sensitivity to water, the residual moisture in the rubber material can spoil the freeze-dried preparation during storage. These specific process requirements have been addressed in this part of ISO 8536 by specifying relevant requirements for freeze drying closures including a test method on determination of residual moisture.

DIN ISO 8536-6:2017 Referenced Document

• DIN EN ISO 15378:2016 Inner packaging materials for pharmaceutical products apply the special requirements of ISO 9001 and refer to Good Manufacturing Practice (GMP)
• DIN EN ISO 8536-1:2011 Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011); German version EN ISO 8536-1:2011
• DIN EN ISO 8536-3:2009 Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles (ISO 8536-3:2009); English version of DIN EN ISO 8536-3:2009-09
• DIN EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003); German version EN ISO 8871-1:2004, text in German and English
• DIN EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); English version of DIN EN ISO 8871-4:2006-09
• DIN EN ISO 8871-5:2017 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016); German version EN ISO 8871-5:2016
• DIN ISO 3302-1:1999 Rubber - Tolerances for products - Part 1: Dimensional tolerances (ISO 3302-1:1996)
• DIN ISO 7619-1:2012 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness) (ISO 7619-1:2010)
• ISO ISO IEC 27001-2013 cor2-2015 technical errata*， 2024-04-20 Update
• ISO 2230:2002 Rubber products - Guidelines for storage
• ISO 3302-1:2014 Rubber - Tolerances for products - Part 1: Dimensional tolerances
• ISO 3302-2:2008 Rubber - Tolerances for products - Part 2: Geometrical tolerances
• ISO 48:2010 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD)

DIN ISO 8536-6:2017 history

• 2017 DIN ISO 8536-6:2017-09
• 1970 DIN ISO 8536-6 E:2017-04 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
• 2017 DIN ISO 8536-6:2017 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2016)
• 2012 DIN ISO 8536-6:2012 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles (ISO 8536-6:2009)
• 0000 DIN ISO 8536-6:1996