Bag / Port Assemblies
Brand: GMPTec
Our Bag / Port Assemblies offer flexible configuration options in both shape and design. These single-use bags are available in flat 2D or 3D formats, with volumes of up to 4000 L. In addition to standard PE film, we provide bags with up to three film layers for enhanced security. The contact layer is made of either LDPE or Aramus™ fluoropolymer, ensuring high performance and reliability.
Features
Benefits
- Customizable 2D or 3D designs with volumes up to 4000 L.
- Bag options with up to 3 film layers for added protection.
- High performance contact layer made from LDPE or Aramus™ fluoropolymer.
- Securely closed open tubing and double packaging.
- Sterilizable by gamma irradiation (up to 40 kGy) and high pressure saturated steam.
- Produced in an ISO Class 7 cleanroom.
- Tested for hydrostatic and tensile strength.
Applications
- Bioreactors
- Cell cultivation
- Formulation
- Sampling
- Feed process
- Waste collection
- Filter rinsing
- Buffer media and fillings
- Shaking and swivel reactors
- Micro carrier separation
- Mixing and purification
Types of Bags
- 2D Media Bag: Available in various sizes with customizable connection points on the surface or front.
- 2D Sampling Bag: Has tubing connections for sampling, available with complete sampling manifolds.
- 2D Filtration Bag: Includes filtration media for processes like separating microcarriers from cells, with multiple connection points for fluid entry and drainage.
- 2D Waver Bag: Flat bag with side holding elements, designed for use on a hinged plate for cell growth. Customizable connections for ventilation, sensors, and media.
- 3D Buffer Bag: For storing or transporting large volumes with freely positioned, customizable connections.
- 3D Recirculation Bag: Features a bottom outlet port and customizable connections for even media mixing when used with a pump.
Types of Films
- Triple Film: Made of a LDPE contact layer with 3 layers, including an EVOH gas barrier and nylon guard, providing maximum security for transport and handling.
- Standard Film: Consists of an LDPE contact layer with two layers, including an EVOH gas barrier and nylon guard, offering high security for cell applications.
- Single Film: Features a LDPE contact layer and a single layer for high transparency, including an EVOH gas barrier and nylon guard.
- Kynar Film: Built with a PVDF contact layer, it is tough, autoclavable, highly chemical-resistant, and does not bind cholesterol.
Specifications
| Sterilization Methods | : | Gamma irradiation (up to 40 kGy) |
| : | High pressure saturated steam | |
| Bag Volumes | : | Up to 4000 L |
| Bag Materials | : | Aramus™ fluoropolymer |
| : | LDPE | |
| Film Material | : | PVDF |
Compliance
- FDA CFR 21
- USP Class VI
- GMP
- Endotoxin Certification
- BST/TSE Certification