Closed ATM View - Health/20-21/2000006
Request for Tender for the Provision of a Portable Isolator System for Sterility Testing of Therapeutic Goods
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TGA wishes to purchase a portable closed system, positive pressure, isolator system in which to conduct Tests for Sterility on a wide range of medicines and medical devices with multiple product presentations and packaging systems.
The TGA Laboratories require a closed system, positive pressure, isolator system that is suitable for performing Tests for Sterility; the critical zone of the isolator system must meet ISO 5 conditions at rest according to ISO 14664 series requirements.
Samples tested for sterility vary in size and complexity and include (but are not restricted to) items such as water soluble medicines, oil soluble medicines, dressings, surgical sutures, catheters and blood bags. Testing is performed by both membrane filtration and direct inoculation methods, thereby requiring an isolator system that facilitates testing of a wide range of products by both methods
6 October 2020