Sartorius Stedim Biotech Sterisart NF alpha 16466-ACD, Инструкция по эксплуатации, Страница: 5 / 24

Sterisart ® NF alpha | Sterisart ® NF gamma – Overview 5
Scope of the lnstructions for Use
These instructions are applicable to the following products:
16466 ACD
Sterisart ® NF alpha with 4 cm vented dual-needle metal spike for closed containers
(pack of 10, individually packed, EtO sterilized)
16467 ACD
Sterisart ® NF alpha with 5.2 cm needle for open containers
(pack of 10, individually packed, EtO sterilized)
16466 GBD
Sterisart ® NF gamma with 4 cm vented dual-needle metal spike for closed containers
(pack of 10, double-packed, gamma irradiation sterilized)
16467 GBD
Sterisart ® NF gamma with 5.2 cm needle for open containers
(pack of 10, double-packed, gamma irradiation sterilized)
Description The listed Sterisart ® systems are ready-for-use assemblies, each consisting of two
(see page 4) clear plastic containers (canisters) which are connected by flexible tubing to a single
sampling probe via a Y-distributor for equivolume liquid transfer into the containers.
Each container has a 50 mm diameter, 0.45 um pore size validated membrane filter
sealed at its base by a clamping technique which avoids diffusion into the filter-
container interface, and a validated sterilizing vent filter fixed to its top. Stepped
rings around the container indicate approximately 50, 75 and 100 ml levels.
The sampling probe is either a 4 cm long vented dual-needle metal spike for spikable,
closed sample containers or a 5.2 cm long straight needle for openable sample
containers.
Colour-coded clamps (two white, two yellow) are premounted to the tubing for
convenient closing of it as required.
All necessary accessories (two rubber caps for the vent filters, two plastic wing nut
plugs for the container outlets, and, for version 16467 only, a short needle with air
sterilizing filter) are included with each system.
Packaging Type Sterisart ® NF alpha:
A box consists of a Sterisart ® system packed with appropriate accessories in
a gas-impermeable, clear plastic tray which is sealed on top by a gas-permeable cover
sheet. The print on the cover gives details of the enclosed system (brief description,
order number, expiration date, sterilization date and lot number) and the green
colour of the integrated sterilization indicator gives visual proof that the ethylene
oxide sterilization which the box has been subjected to was effective.