features Features of Steritainer Plus

Sterility Assurance Level (SAL) ≤ 10-6 and Low Elution

  • Sterility
    Steritainer Plus is a validated sterilized bag with Sterility Assurance Level [SAL] of ≤ 10-6 and can be used for storing and transporting fluids requiring a sterile environment in a container, without the need for washing and sterilization.
    Steritainer Plus is individually packaged with a double wrapping.
  • Low Elution
    Steritainer Plus is made from additive-free polyethylene, completely eliminating effects of dissolved materials on content fluid. Steritainer Plus can be reliably used in any process.
  • Cleanliness
    By employing a blow-molding method in a completely closed system environment and unmanned operation processes in a cleanliness control area, Steritainer Plus completely eliminates the risk of extrinsic contamination.

3D (three-dimensional) conformation using a blow-molding method realizing both space-saving and high-strength features

Space-Saving Feature due to 3D Conformation
Steritainer Plus features a space-saving installation area allowing it to be installed in locations with restricted space, such as safety cabinets. Steritainer Plus is foldable before and after use and easy to store.
High-Strength Design Applicable to Long-Distance Transportation
Steritainer Plus has high strength performance, which protects against breakage of the bag, even for transportation distances of 1,000 km transportation or fall from a 2 m height, so Steritainer Plus can be used for transportation between core facilities.
Supports Freezing at -80°C
Steritainer Plus can be used for freeze storage down to -80°C, which is applicable to biopharmaceuticals processes.

Steritainer Plus Molding Process

  • 01 Parison injection

    Plastic heated in the extruder is cylindrically extruded.

  • 02 Mold closing

    The metal mold is slowly closed, with the parison clipped by the mold parts.

  • 03 Blowing to cooling

    The parison is inflated with blown air within the metal mold and left to stand for a while for cooling down.

  • 04 Taking out the product

    The product is taken out from the metal mold. Unnecessary parts (burrs) are removed and recycled.

point

  • The thermoforming in a closed system environment allows for complete elimination of extrinsic contamination.
  • Cleanliness inside the container is ensured by filtration control of the blown air.
  • All processes are fully automated, and leak tests are performed for each product on the automated line.

Tubing Units Enabling Various Connections in Closed Systems

Detachable Tubing Units
The detachable tubing unit options enables customers to freely arrange a prototype process design. In the mass production process, these tubing unit options can contribute to standardization of items.
Ready-To-Use Standard Options
Various standard tubing unit options are readily available. Reasonable responses can be provided in a short delivery time.
Full Customizable Tubing Units
In the customization of tubing, customers can freely request parts and shapes meeting their needs. Tubing unit configurations at delivery can be selected from tubing units separated from or attached to the main unit, which enables more flexible customization patterns.

Options

Tubing Options

3-Port Connector

  • A connector with 3 ports for fluid injection, fluid discharge, and aeration
  • Sterilized. One package contains 2 types: 1/4 inch type and 3/8 inch type.
  • Used for tubing unit designs.

3-Port Connector ASSY

  • A tubing unit with tubing and couplers assembled to a 3-port connector
  • Sterilized. Two types are available: 1/4 inch type and 3/8 inch type.

1-Port Connector (developmental item)

  • A connector specialized for injection and discharge of fluid
  • Two types are available: 3/8 inch type and 1/2 inch type.
  • Can be used for storage of culture medium and collection of culture solution.

Extension Tubing Unit (developmental item)

  • A tubing unit with a length of 1 m used for connections to various devices
  • Various specifications specialized to each device connection are available
  • Can be used for tube sealers and welders.

Options for Storage and Transportation

Outer Container for Storage

  • A plastic outer container which can be stacked for storage of fluid-filled Steritainer Plus
  • Steritainer Plus housed in the container is for in-house storage, relocation, and transportation between core facilities.
  • Two types are available: 10 L and 20 L sizes.

Vertical Flip Rack (available for both 10 L and 20 L)

  • A space-saving rack used for fluid injection into and discharge from Steritainer Plus
  • Residual fluid can be completely discharged by flipping the container upside down with just a single operation.
  • One rack can be used for both 10 L and 20 L containers.

Outer Container for Refrigerated Transportation (developmental item)

  • A single-use transportation case that can be used for refrigerated and freeze transportation

Options for Use in Safety Cabinets

Stand (available for sizes of 5 L to 20 L)

  • A small size rack which can be installed upside down, intended for use in safety cabinets
  • The opening faces downward and facilitates complete discharge of residual fluid.
  • The container can be handled through the opening of the safety cabinet.

Stand for Filling (available for both 5 L and 10 L)

  • Used for filling bags in safety cabinets.
  • Holding the opening of the bag with a holder enables stable filling.
  • Bags can be used as an alternative to bottles.

Options For Cultures

Culture shaker Device Unit (developmental item)

  • To a Culture shaker device, 5 L Steritainer Plus is applicable.
  • A detachable tubing unit is attached.
  • This unit can also be used in stirring processes in closed systems.

introduction video Steritainer Plus
Introduction Video

Case Study Video

  • Providing culture medium to a suspension bioreactor (using a Vertical Flip Rack).

  • Conditioning culture medium using a magnetic stirrer.

  • Filling with culture medium in a safety cabinet (using a Stand for Filling).

  • Filling with culture medium in a safety cabinet (using an Outer Container).

  • Providing culture medium to an adherent multi-layer flask (HYPERStack) (using a Stand).

  • Collection of culture solution from an adherent multi-layer flask (HYPERStack) (using an Outer Container).

  • Culture shaker Device (using a 5 L Steritainer Plus)

FAQ

What quality standard tests does Steritainer Plus meet?
Steritainer Plus conforms to the Japanese Pharmacopoeia (JP) and United States Pharmacopeia (USP Class Ⅳ).
What kind of material is Steritainer Plus made from?
Steritainer Plus is made from polyethylene. Additive-free polyethylene is used, and no adhesive-like materials are used for the blow molding.
What is the advantage of the three-dimensional (3D) shape?
The biggest advantage is the space saving. Currently, 2D-shape film bags (referred to as pillow type) are predominantly used as a common single-use bag (20 L or less). The footprint of Steritainer Plus is about one-third smaller than that of the 2D-shape bags.
Conventionally, 3D-shape containers have been widely used for retention and transport of fluid. This is because the 3D shape is reasonable in terms of space saving and handling ability.
Steritainer Plus is foldable despite its 3D shape and does not take up much space when it is stored. The 3D bag is also suitable for customers who use bulky bottles or heavy glass bottles.
What is the reason for the 5, 10, and 20 L product specifications?
The types of items are narrowed as much as possible to ensure stable quality and short delivery time.
For the currently available 3 types, fully automated production and online automated leak testing have been established. We decided to minimize manual processes as much as possible to ensure the quality of the products.
The products with these volumes have to be handled manually, and the heavy weight becomes overloaded. The optional vertical flip rack can lighten the load on persons who handle the bags. We developed the product with the aim of standardizing the work so it can be done safely by anyone.
What is the difference between Steritainer Plus and Steritainer?
The same container is used for Steritainer Plus and Steritainer.
The difference is in the packaging units. Steritainer Plus is individually packaged. By contrast, collective packaging (bulk) is used for Steritainer with one package containing 25 pieces of the 20 L bags and 50 pieces of the 10 L and 5 L bags.
What kind of tests have been conducted?
In addition to various tests conducted under the Japanese Pharmacopoeia (JP) and United States Pharmacopeia (USP Class Ⅳ) as mentioned above, we have also performed testing including for endotoxin, particulate matter, protein absorption, and extracts. If you need detailed information, we can provide a list of technical tests conducted for Steritainer. Please do not hesitate to ask us for the list.
What is difference between the “3-port connector” and “3-port connector ASSY” in use?
The “3-port connector” is composed only of connection parts and provides you with the opportunity of freely designing a tube layout of your own. If you already have tube and/or coupler parts, you can assemble those parts with the “3-port connector,” which is useful for introducing self-build models when you customize the design, for example, in research development. On the other hand, if you do not have time to arrange and/or assemble parts and want to use connectors immediately, you can choose the “3-port connector ASSY.” The “3-port connector ASSY” has a low contamination risk and is easy to connect to existing devices and/or bags, making it applicable to all customers.
We can also offer various standard options specialized to your intended use. These options can be selected in combinations depending on the purpose, and you can customize the options along with freely-designed tube patterns.
Is customization available for tubing units?
The tubing units can be customized. You can freely choose the materials and length of tubes, connection parts such as couplers and sterile connectors, and other parts such as filters, so that full customization is available to meet your requirements. We can deliver tubing units with Steritainer Plus connected or provide individually-sterilized tubing units and Steritainer Plus separately. Using standardized parts can be useful for diminishing inventory variability.
How long is the delivery time?
Although Steritainer Plus is an in-house manufactured product, it takes 1 to 2 months from your order to delivery because of the sterilization process after your order is placed. If you request customized tubing units, the delivery time will be longer, so please contact us separately in that regard.
Where can I purchase Steritainer Plus?
The products are sold nationwide through agents dealing with laboratory instruments across the country. Please ask your dealer, or contact us for introduction to a dealer near you.
What are the prices for the products?
Basically, we do not offer direct sales, and the products can be only purchased through agents dealing with laboratory instruments or test reagents. Please ask your agents for the prices for end users.

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