Steritest™ EZ Double-Packed, Gamma Sterilized Sterility Testing Device

Double packaging enhances sterility testing reliability

Description

   • Gamma sterilized and double packed for quick transfer into sterility testing environments, simplifying decontamination procedures and saving time.
   • Sealed bag provides optimum decontamination of the outer bag and easy bag opening.
   • Outer packaging materials ensure complete integrity of the bags during transportation, minimizing risk of piercing or damage.
   • Primary blister packaging can be hung or stacked within the testing environment, minimizing the test area requirements.
   • Steritest EZ devices offer simplified handling, reduce foaming during critical filtration steps and provide comprehensive traceability.

Sterility testing is one of the most crucial and timeconsuming steps in pharmaceutical processing. Although it is a critical step, it does not have to be a difficult one. Millipore’s Steritest EZ canister device simplifies every aspect of testing, from handling to traceability to reliability, all within a closed concept system. The ease and convenience enables you to increase productivity while maintaining the highest levels of quality.
For more than two decades, Millipore has been the market leader in sterility testing. Steritest EZ doublepacked, gamma sterilized devices, continues to set the standard for sterility testing excellence.

Double Packed Saves Time

Steritest EZ devices are packed to ensure optimum cleanliness. The double packaging allows operators to open the outer bag in a clean room and bring the sterile package into a laminar flow hood or isolator environment. A tear primer on the outer bag enables gloved operators to open the outer bag easily, eliminating the use of scissors. This simplified decontamination procedure saves operator time.

Outer Bag Designed to Eliminate the Risk of Contamination

During manufacture, the bag is sealed and then trimmed to remove any potential pockets where contamination could reside. This packaging feature ensures optimum decontamination of the bag prior to introduction in a clean room.

Outer Bag Designed to keep Steritest EZ Devices Sterile

Unlike standard bags, which are susceptible to tears during shipping and therefore potential contamination, the new Steritest EZ double-packed devices are made of a thick multilayer 170 μm film (Polyamide – Polyethylene derivate). This material was selected for its mechanical resistance. The bags are vacuum sealed and the outer box contains foam to further protect the product. Vibration tests, drop tests and shipping trials have confirmed the bags’ integrity from manufacturing plant to lab.

Primary Package Simplifies Operational Steps

The Steritest EZ blister is made of a rigid PETG shell for optimal protection during shipping and handling, a layer of which is designed to be easily peeled for opening. The shells are stackable, saving valuable space under laminar flow hoods or inside isolators. For isolator users, a hole is positioned to hang the devices prior to decontamination cycles. Catalogue and lot numbers, sterilization date and expiration date are printed on each blister for easy traceability.

Needle Adapter Increases Efficiency and Security

The Steritest EZ needle adapter enables fast and easy manipulation of drug products.
   • Fits most size test vials; eliminates blockage when testing drugs in vials with thick septa
   • Integrated vent eliminates the need for separate vent needle (reference TZHA LV 205 and TZHA SV 205), reducing the handling steps
   • Ergonomic, non-skid design provides a secure grip for gloved operations, especially in isolators

Canister Inlet Reduces Foaming, Speeds Filtration

In the past, operators needed to reduce pump speed to minimize foam when testing protein solutions or adding media. The result was slower filtration. Now you can test faster and reduce foam with the improved canister inlet design. This feature, coupled with our high flow mixed esters of cellulose (HA) membrane, improves reliability while allowing you to maintain high pump speeds and decrease testing time.

Easy Handling

With pre-installed clamps on the tubing, the Steritest EZ double-packed, gamma sterilized device reduces and simplifies steps in sterility testing. You can easily close and re-open the clamps during testing by simply pressing down or releasing as necessary. In addition, with the marked tubing, handling and identifying the canisters during media transfer are easier. The winged red plugs offer more efficient and easier handling.

Completely Closed for Complete Confidence

Pharmaceutical products are never exposed to the environment during the testing process with Steritest EZ devices. Sampling, filtration, rinsing, media addition and incubation are all conducted within a closed system. There is no need to open containers or manipulate the membrane at any time — greatly reducing the risk of adventitious contamination. Double packaging further enhances quality, so you can be assured of unmatched sterility in every step.

Quality Made Simple

At Millipore, we take nothing for granted. So in addition to the new quality assurance features of our Steritest EZ device, we also rigorously test each device during and after manufacturing.
   • 100% integrity testing on every canister
   • Strict physical and microbiological tests on assembled Steritest EZ devices prior to release from manufacturing
   • Certificate of Quality provided with each system for your batch records
   • Easy traceability with catalogue number, lot number and expiration date printed on each canister

Specifications (return to top)