Steritest EZ and Steritest Sterility Testing Devices

Steritest EZ and Steritest Sterility Testing Devices

Convenient and Versatile
Steritest EZ and Steritest sterility testing devices are sterile, non-toxic and non-pyrogenic. They are supplied individually blister packaged and ready for quick installation in the Steritest Equinox pump. Different canister materials, membrane types and adapters match the individual requirements of pharmaceutical test product packaging or medical devices.


New Steritest EZ Design
Our next generation sterility testing device, Steritest EZ, incorporates the same materials of construction as the Steritest devices while offering a number of ergonomic benefits. The 850 mm tubing length simplifies set-up with ample room to perform the manipulations involved in sterility testing. Closing and re-opening the pre-installed clamps during testing is as simple as pressing down or releasing as necessary, reducing resting time. The innovative inlet design of Steritest EZ canister reduces foaming enabling faster filtration. And, the unique needle adapters enable fast and easy manipulation of liquid drugs. Designed to fit the majority of drug containers, the risk of blockage while testing drugs in vials with a thick septa is significantly reduced. The ergonomic, non-skid design offers a firm grip for gloved operators, especially in isolators.

The double-packed, gamma sterilized testing devices ensure optimum cleanliness. Double packaging allows an operator to open the outer bag in a clean room and bring the cleanest possible package into a laminar flow hood or isolator environment. The tear primer on the outer bag allows an operator wearing gloves to open the bag without using scissors.


Stringent Quality Program
Devices are manufactured and validated to stringent quality standards in ISO^® 9001:2000-certified manufacturing facilities, which have been audited by numerous pharmaceutical and biotechnology customers . The quality program for Steritest EZ and Steritest devices includes incoming material controls, in-process controls for every manufacturing step, and performance and reliability controls for finished product. Each device is 100% tested for integrity and subjected to visual uniformity checks.

Each manufacturing lot is subjected to numerous tests, including:

- Fertility and retention
- Sterility and sterility efficiency
- Membrane bubble point and flow rate
- Maximum burst pressure
- Ethylene oxide residuals for ETO sterilized units
- Toxicity and pyrogenicity tests (performed on an audit basis)
Each box of Steritest and Steritest EZ devices contains a detailed lot-specific Certificate of Quality for use in sterility test validation.


Specifications    (return to top)
Materials of Construction
Canisters: SAN (polyamide for solvents)
Tubing set: PVC
Membranes: 0.45 µm mixed esters of cellulose or Durapore (PVDF)

Dimensions
Canisters: 51 mm D x 120 mm H
Tubing Set Lengths:
Steritest: 750 mm
Steritest EZ: 850 mm

Temperature
45 °C max.

Pressure
3.2 bar max.