An intelligent liquid transfer pump for sterility testing
Sterility testing is one of the most crucial steps in pharmaceutical product release. False positives, false negatives, equipment failure and human error can cost you time, money and ultimately your product.
The Steritest Equinox transfer pump is a software controlled peristaltic pump used for the safe, uniform transfer of drug samples from various packaging formats through the Steritest sterility testing devices. The Steritest Equinox pump and Steritest and Steritest EZ devices deliver unmatched sterility testing consistency and reliability.
Steritest Equinox Pump for Laminar Flow Hoods
The Steritest Equinox pump for laminar flow hoods fits in both horizontal and vertical Class A/ Class 100 laminar flow hoods. Its unique profile prevents undesirable air turbulence in the area where handling is performed, eliminating the risk of false positives.
Steritest Equinox Pump for Isolators
The Steritest Equinox pump for isolator fits in both glove and half-suit isolators. Its profile ensures perfect decontamination inside isolators, eliminating the risk of false positives. Its unique design makes it easy to connect and disconnect from an isolator work table during maintenance.
Ergonomic Design
Both pumps were orgonomically designed for easy operation and cleanability. The drain tray as well as the polished 316L stainless steel surfaces of the pump, pump head and bottle holder are easily cleaned using most standard decontamination agents.
The Next Generation Intelligent Pump
From a computer, standard operating procedures (SOPs) can be developed and then transferred onto the Steritest Equinox pump.
Analysts can select either manual or automated mode. In manual mode, the Steritest Equinox pump will prompt the analyst to enter data at each step of the procedure.
In automated mode, an analyst simply selects the appropriate SOP for the sample to test from the Steritest Equinox control panel. The Steritest Equinox pump will walk the analyst through each step, acting as a training guide, thereby supporting good manufacturing practices. The various steps in the procedure, corresponding pump speed and related information are displayed on the control panel, improving repeatability and reliability.
Fast and Reliable Sterility Testing Transfer System
Designed for use with Steritest and Steritest EZ devices, the automatic pump head makes it easy to load and unload Steritest and Steritest EZ unit tubing and is equipped with a precision “stop control” for low volume sampling. A built-in timer enables analysts to pre-set the time required for the transfer of product into both canisters. This is critical for product exposed to the environment such as glass ampoules where there is a risk of introducing non-sterile air into the canisters and generating false positives.
A pressure control system constantly monitors the pressure inside both Steritest and Steritest EZ canisters ensuring that the system is running within acceptable pressure limits at all times. An alarm informs the operator of any pressure increase above specifications.
An external foot switch operates the pump in either “continuous” or “two-way” operation mode.
Validation Support
Comprehensive protocols are available to make validation faster and easier. The validation protocol book contains ready-to-use installation, operation, and performance qualification protocols that are written to the same standards as the protocols used to validate pharmaceutical processes.
| Materials of Construction |
| Pump | 316L stainless steel frame, pump head, pump head cover, and bottle holder; polyester keypad and screen window |
| Drain Tray | Polyacetal |
| Tubing for Drain Tray | Silicone |
| Dimensions and Weight |
| Pump for Laminar Flow Hoods | Pump for Isolators |
| Width, cm (in.) | Pump: 35 (14); Pump fully equipped: 59 (23) | Pump: 35 (14); Pump fully equipped: 59 (23) |
| Depth, cm (in.) | Pump: 30 (12) Pump Fully Equipped: 34 (13) | Pump: 32.2 (13) Pump Fully Equipped: 35 (14) |
| Height, cm (in.) | Pump: 25 (10); Pump Fully Equipped: 53 (21) | Pump: 25 (10); Pump Fully Equipped: 53 (21) |
| Weight, kg (lb) | Pump: 14 (31); Pump fully equipped: 17 (37) | Pump: 18.5 (41); Pump fully equipped: 22 (48.5) |
| Operational Requirements |
| Temperature, °C | 15–40 |
| Relative humidity | <90% |
| Altitude | <3000 m (9842 ft) |
| Electrical Requirement | 115–230 V |
| Input to Pump from Power Supply | 24 VDC, 150 W |
| Sterilization | Pump head cover, roller knob, bottle holder and drain tray may be autoclaved for 30 minutes at 121 °C or 10 minutes at 134 °C |
| Canister | Compatible with Steritest, Sterisolutest ®, Steridilutor® and Steritest EZ canisters |
| Regulatory Information | The Steritest Equinox pumps are compliant with Electromagnetic Compatibility Directive 89/336/EEC, and are CE marked |