Sartorius Stedim Biotech Sterisart NF alpha 16466-ACD, Instructions For Use Manual, Page: 6 / 24

6 Sterisart ® NF alpha | Sterisart ® NF gamma – Overview
Type Sterisart ® NF gamma:
Packaging as for Sterisart ® NF alpha, with the exception that the gas-impermeable,
clear plastic tray is sealed with gas-impermeable cover sheet. Sterilization is carried
out with gamma irradiation. The gas-impermeable boxes enable the outer surfaces
to be sterilized by usual isolator procedures without passage of sterilant through to
the box and the Sterisart
® system.
A change from orange to red at the sterilization indicator located on the outer
standard box as well as on the accessory package inside the individual system shows
that the product has been reliably sterilized by gamma irradiation.
A standard pack of Sterisart
® alpha contains ten single sterile packed systems.
A standard pack of Sterisart ® gamma contains ten sterile single packed systems which
are altogether additionally packed in a plastic bag.
Each alpha or gamma system has a colour sterilization indicator.
A yellow (16466) respectivily blue (16467) colour code point on the front side inside
the packaging indicates the two different types additionally.
Intended purpose Sterisart ® NF alpha and gamma systems have been specifically designed for carrying
out the sterility test by the Membrane Filter Method as described in various
Pharmacopoeias, in combination with a dedicated peristaltic pump. The two
different versions described allow the testing of pharmaceutical solutions held in
containers that are closed with a spikable closure (version 16466), or in openable
containers, ampoules or plastic bags (version 16467).
Sterisart
® NF gamma is the preferred type for sterility testing in isolators.
Important notes on safe and correct usage
Sterisart ® systems are only to be used with peristaltic pumps designed for
sterility testing with such systems, such as Sterisart ® Universal pumps 16419
and 16420.
All necessary precautions must be taken to avoid secondary contamination.
Only handle the parts with sterile gloves.
Spikes and needles are very sharp. Take great care to avoid damage to gloves
or injury to hands when handling them.
Check the colour indicator and the expiration date on the box prior to using
a system.
To avoid media leakage during incubation, fit plastic wing nut plugs firmly
to the outlets of Sterisart
® containers by twisting them clockwise while pressing
them firmly on.
Never „stick“ the rubber caps to the Sterisart ® vent filters!
The caps are intended to act not only as closures, but also as safety valves.
Should exceptionally high pressure build up in the containers during pumping
(high pump speed, clogged fiIter), normally fitted caps will blow off before
the burst pressures of other system parts are reached.