4
Introduction
System overview
The Steritest
™
Symbio peristaltic pumps are used for sterility testing and are available in three
versions: LFH, ISL, and FLEX. Combined with optional accessories, the pumps provide a wide
range of installation possibilities, allowing 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 along with Steritest
™
devices.
Many type 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
pump speed automatically until the pressure returns to normal.
The microorganisms present in the sample are captured on the Steritest
™
canisters microporous
membrane. 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.
Additional Features
Tests can be run in either the Standard Mode, in which filtration parameters are chosen
manually, or in the Test Method Mode, in which every step of the method appears on the
screen with preloaded parameters for speed and time to ensure there is no deviation from the
approved test protocol. The test methods are created with the Steritest
™
Symbio Software and
transferred to the Steritest
™
Symbio pump through a network cable or with USB flash drive.
The pump and PC software can be used in ten languages (German, English, Spanish, French,
Italian, Portuguese, Japanese, Simplified Chinese, Russian, and Turkish).
The drain tray and bottle holder are ergonomically positioned around the pump head for easy
access in limited-space environments.
