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<p class="MsoBodyText"><span lang="EN-GB">This document 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.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The dimensional requirements are not applicable to barrier-coated closures.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Closures specified in this document are intended for single use only.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.</span></p>
Reģistrācijas numurs (WIID)
85867
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document 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.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The dimensional requirements are not applicable to barrier-coated closures.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">Closures specified in this document are intended for single use only.</span></p>
<p class="Note"><span lang="EN-GB">NOTE<span style="mso-tab-count: 1;"> </span>The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.</span></p>
