Single-use bags or stainless steel vessels: when to choose each
Single-use bags or stainless steel vessels: cleaning and validation, cross-contamination, scale, costs and waste, and what to specify in a single-use bag.
Single-use and bioprocessing
ExoFlex 2D Cerrada
Closed 2D single-use bag
2D single-use bags from 50 mL to 50 L for the pharmaceutical and biotech industries
Closed 2D single-use bag with ULDPE/EVOH/HDPE film, from 50 mL to 50 L, manufactured in an ISO 7 cleanroom for vaccines, injectables and culture media.
- Line
- ExoFlex · ULDPE / EVOH / HDPE multilayer film
- Series
- BDA
- Manufacturing
- Argentina · ISO 7 cleanroom
Description
ExoFlex 2D Cerrada is a single-use bag for handling liquids in pharmaceutical and biotech processes: production of vaccines, injectable drugs, cell culture media, buffers and process solutions. Each batch uses a new bag, with no internal cleaning or steam sterilization between batches.
ExoFlex bags and systems are designed, manufactured and assembled in Argentina, in an ISO 7 cleanroom. Each system is configured to the customer's process: volume, ports, tubing and connectors.
The film has five layers: the fluid-contact layer is 233 µm ultra-low-density polyethylene (ULDPE), with an EVOH gas barrier and a high-density polyethylene (HDPE) outer layer. Standard configurations range from 50 to 500 mL with two ports and from 1 to 50 L with three, with platinum-cured silicone tubing, peristaltic pump grade silicone or TPE.
Each system carries a unique lot number and is supplied with a quality certificate. Bag integrity is tested at the plant, the material meets the USP <88> criteria for Class VI plastics, and a validation guide is available.
Designed and made in Argentina
Designed, manufactured and assembled in Argentina, in an ISO 7 cleanroom, to the volume, ports and tubing of each process.
Five-layer film with EVOH barrier
233 µm ULDPE contact layer, 28 µm EVOH gas barrier and 32 µm HDPE outer layer.
From 50 mL to 50 L
2-port bags from 50 to 500 mL and 3-port bags from 1 to 50 L, with tubing from 1/8″ to 3/8″ inner diameter.
USP <88> Class VI
No significant adverse reactions in biological reactivity tests: meets the criteria for Class VI plastics.
Integrity and lot traceability
Integrity tested at the plant, unique lot number and quality certificate per lot. Validation guide available.
Process-specific tubing and connectors
Platinum-cured silicone, peristaltic pump silicone or TPE; 1½″ clamp, luer, male/female connector or needleless sampling.
Technical specifications
Request the PDF catalogMaterials
| Film | 5 layers: ULDPE (contact) · adhesive · EVOH (gas barrier) · adhesive · HDPE (outer) |
|---|---|
| Fluid-contact layer | Ultra-low-density polyethylene (ULDPE), 233 µm |
| Product transfer tubing | Platinum-cured silicone (code S) |
| Peristaltic pump tubing | Platinum-cured silicone, peristaltic pump grade (code R) |
| Tubing for welding or sealing | Thermoplastic TPE (code T) |
Configuration
| Volumes with 2 ports | 50, 100, 250 and 500 mL |
|---|---|
| Volumes with 3 ports | 1, 5, 10, 20 and 50 L |
| Port type | Polyethylene (50 to 500 mL) · boat (1 to 50 L) |
| Tubing inner diameter, 50 to 500 mL | 1/8″ on both ports |
| Tubing inner diameter, 1 L | 1/4″ on ports 1 and 2 · 1/8″ on port 3 |
| Tubing inner diameter, 5 to 50 L | 3/8″ on ports 1 and 2 · 1/8″ on port 3 |
Standard connectors
| MPC | Male / female, with sealing cap |
|---|---|
| Clamp 1½″ | With clamp, gasket and blank end cap |
| Luer lock | With plug |
| Needleless sampling port | With cap, for syringe |
Options and accessories
| Storage | Trays and racks for in-plant storage |
|---|---|
| Transport | Rigid containers for transport and protection |
| Mobility | Carts and mobile frames |
Quality and compliance
- Biological reactivity per USP <88>: meets the acceptance criteria for Class VI plastics
- Manufactured in an ISO 7 cleanroom
- Bag integrity tested at the plant
- Quality certificate per lot
- Traceability by lot number
- Validation guide available
Selection data
| Layer | Thickness | Material |
|---|---|---|
| Fluid contact | 233 µm | Ultra-low-density polyethylene (ULDPE) |
| Tie layer | 21 µm | Adhesive |
| Gas barrier | 28 µm | Ethylene vinyl alcohol (EVOH) |
| Tie layer | 21 µm | Adhesive |
| Protective outer layer | 32 µm | High-density polyethylene (HDPE) |
Layers in order, from the fluid side to the outside.
| Volume | Code | Port type | Ports | Tubing inner Ø (1 · 2 · 3) | Standard connectors (1 · 2 · 3) |
|---|---|---|---|---|---|
| 50 mL | 9001 | Polyethylene (P) | 2 | 1/8″ · — · 1/8″ | M0N · M0M · L0N · L0L |
| 100 mL | 9002 | Polyethylene (P) | 2 | 1/8″ · — · 1/8″ | M0N · M0M · L0N · L0L |
| 250 mL | 0002 | Polyethylene (P) | 2 | 1/8″ · — · 1/8″ | M0N · M0M · L0N · L0L |
| 500 mL | 0005 | Polyethylene (P) | 2 | 1/8″ · — · 1/8″ | M0N · M0M · L0N · L0L |
| 1 L | 0010 | Boat (B) | 3 | 1/4″ · 1/4″ · 1/8″ | MMN · MMM · MML · LLN · LLL · CMN · CMM · CML · CLN · CLL · CCN |
| 5 L | 0050 | Boat (B) | 3 | 3/8″ · 3/8″ · 1/8″ | MMN · MMM · MML · CMN · CMM · CML · CCN · CCM · CCL |
| 10 L | 0100 | Boat (B) | 3 | 3/8″ · 3/8″ · 1/8″ | MMN · MMM · MML · CMN · CMM · CML · CCN · CCM · CCL |
| 20 L | 0200 | Boat (B) | 3 | 3/8″ · 3/8″ · 1/8″ | MMN · MMM · MML · CMN · CMM · CML · CCN · CCM · CCL |
| 50 L | 0500 | Boat (B) | 3 | 3/8″ · 3/8″ · 1/8″ | MMN · MMM · MML · CMN · CMM · CML · CCN · CCM · CCL |
Each combination is offered with silicone (S), peristaltic pump silicone (R) or TPE (T) tubing; those with a clamp are offered with S or T. Connectors: M = MPC with cap · L = luer lock with plug · C = clamp 1½″ · N = needleless sampling port · 0 = no port.
Product selection
Build the ordering code
Pick each option and the code builds itself. With the code, the quote comes back faster and without back-and-forth.
Applications
- Vaccine production
- Injectable drugs
- Cell culture media
- Buffers
- Process solutions
Industries
Pharmaceutical and biotechFrequently asked questions
What volumes are available?
Standard configurations of 50, 100, 250 and 500 mL with two ports, and of 1, 5, 10, 20 and 50 L with three ports. Each one can be configured with other combinations of tubing, lengths, connectors and sampling ports.
What is the film made of?
It is a five-layer film: an ultra-low-density polyethylene fluid-contact layer (ULDPE, 233 µm), two 21 µm adhesive tie layers, an EVOH gas barrier (28 µm) and a high-density polyethylene outer layer (HDPE, 32 µm).
What biocompatibility tests has it passed?
The bags passed the USP <88> biological reactivity tests in animals (intraperitoneal injection, systemic injection and intramuscular implantation) with no significant adverse reactions, and they meet the acceptance criteria for Class VI plastics.
Which tubing is right for a peristaltic pump?
Platinum-cured silicone, peristaltic pump grade (code R). For product transfer, platinum-cured silicone (S) is used, and for heat welding or sealing, thermoplastic TPE (T).
What documentation comes with each lot?
Each system has a unique lot number for traceability and is supplied with a quality certificate per lot. Bag integrity is tested at the plant and a validation guide is available.
Technical blog
Further reading
Talk to engineering
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