Your shopping cart is empty!
PDF Preview
Compressed Gas Association , 11/29/2018
Publisher: CGA
File Format: PDF
$64.00$128.00
CGA P-8.2 provides the Compressed Gas Association (CGA) position and guidance on the manufacturing, bulk product storage, and cargo transport unit filling validation activities that take place at a typical air separation unit (ASU) that is manufacturing medical oxygen, medical nitrogen, or both. Variations from the typical ASU process configurations can exist. Companies shall assess variations and determine if deviations from this guidance are necessary.
The approach and activities in this publication are designed to ensure that these gases, which are classified as drug products, have the claimed identity, strength, quality, and purity. Scientific, documented studies will show that the given utility, system, process, or piece of equipment:
This publication addresses validation for ASU cryogenic manufacturing and cargo transport unit filling processes pertaining to medical oxygen and medical nitrogen.
$64.00 $128.00
$43.00 $87.00
$119.00 $238.84
$110.00 $220.00
$11.00 $23.00