The GMPTEC bag assemblies are free configurable in their shape and design. These single-use bags are available as flat 2D or 3D format with volumes up to 4000 liters. Besides to the regular PE film, we also offer bags with up to 3 film layers, which guarantees a very high security. The contact areas of the bags are made of PE, PVDF and Aramus™- fluoropolymer.
Single-use Bag Assemblies are being used in the biopharmaceutical industry in many shapes, sizes and also for many different applications. The GMPTEC portfolio contains the following categories of bags:
2D Medium Bag – In the 2D format we offer a variety of sizes of single-use bag assemblies. Also, the connections on those can be manufactured according to the individual requirements. The connections can be mounted at the surface of the bag or frontal.
2D Sampling Bag – We offer single sampling bags with the required tubing connections to attach the bag to the position where samples are to be taken or complete sampling manifolds. Manifolds usually consist of several bags that are connected by a tubing distribution system.
2D Filtration Bags – Within the regular 2D bag is a filtration tissue, which is available in different sizes. The medium can access into the bag through one or several connections and can also be drained through others. During an application the medium passes through the tissue to be filtered. One example of an application is the separation of micro carrier and also cells or antibodies.
2D Swivel Reactor – This is a flat bag with holding elements on both sides. It can be set up on a hinged plate. In the bag assembly occurs a cell growth due to the shaking movement. The necessary connections like for ventilation, sensors (pH, oxygen, temperature) and also incoming media are configurable.
3D Buffer Bag – A bag assembly in a 3-dimensional format for storing or transporting big volumes. The connections are free positionable on the surface of the bag. They can be manufactured according to the supportive tank.
3D Mixing Bag – This type of bag can be manufactured according to individual connections or also tubing assemblies. On the lowest point of the bag is a tubing which functions as a riser pipe. When activating a pump, this and also another connection activate a circulation, which allows the medium in the bag to get mixed evenly.
Bag Assembly applications:
- Cell cultivation
- Sampling bag
- Buffer medium
- Waste collection
- Rinsing bag for filter wetting
- Buffer bag in filling
- Shaking reactor and also swivel reactor
- Micro carrier separation
Bag Assemblies are conform to:
- FDA CFR 21
- USP Cl. VI
- GMP conformity
- Endotoxin statement
- BST/TSE certification
- Irradiation up to 40 kGy
- Cleanroom ISO class 7 production
- Hydrostatic and tensile strength tested
- Open tubings always securly closed
- Double packaged (standard)
- We use all kinds of tubings, filters, connectors, couplers, flanges and more
GMPTEC Bag Assemblies consist of the following films:
Tripple film – contact area LDPE, three film layers, with EVOH gas barrier and nylon guard, highest security at transport or handling.
Standard film – contact area LDPE, two film layers, high security in process, with EVOH gas barrier, with nylon guard, suits cell applications
Single film – contact area LDPE, one film layer, very transparent, mit EVOH gas barrier, with nylon guard.
Kynar film – contact area PVDF, very tough, autoclavable, no binding of cholesterol, high chemical resistance.