Millipore Sigma Steritest - Introduction; System Overview; About this Manual

Page 5 of 113
Introduction
System overview
The Steritest
®
Symbio peristaltic pumps are used for sterility testing and are
available in three versions. Combined with optional accessories, the pumps
provide a wide range of installation possibilities (see Steritest
®
Symbio Pump
Versions), enabling integration in all testing environments (laminar flow hood,
biosafety cabinet, clean room, and isolator), including existing isolators without
table rework.
The Steritest
®
Symbio pumps have been designed to be used with Steritest
®
devices. Many types of sterile products can be tested with the Steritest
®
system,
including:
• Large- and small-volume parenteral solutions in glass or plastic bottles,
collapsible bags, ampoules, and vials
• Pre-filled syringes
• Lyophilized and other soluble products in ampoules or vials
• Antibiotics in ampoules or vials
• Medical devices
• Difficult-to-dissolve powders
The easy-load automatic pump head facilitates the Steritest
®
tubing placement in
an isolator configuration and protects the user from the rotor.
A timer coupled with a rotor position compensation provides repeatability of
small-volume sampling.
A pressure control system constantly monitors the pressure inside both canisters.
An alarm signals pressure increases above the specifications. In regulation mode,
the pump decreases the pumping speed automatically until the pressure returns
to normal.
The microorganisms present in the sample are captured on the microporous
membrane in the Steritest
®
canisters . Appropriate medium is pumped into
each canister separately to promote the growth of the captured organisms. The
canisters are incubated and examined for contamination in accordance with the
relevant pharmacopoeia.
About this Manual
All screen shots and drawings in this manual are examples and may vary
depending on the pump version. All dimensions indicated in the illustrations are in
millimeters.