EVO Bag for Closed Cell Culture

Intended Use: The OriGen Biomedical® Evolve bag is intended for use in cell culture.

Registration

FDA 510(k) Exempt.
EU: For Research Use Only.

OriGen Biomedical sells directly and works with a network of global distributors. For availability in your country, please contact us below.

  • Biologically Safe

    Made of EVO, a proprietary copolymer, the Evolve bag is biologically safe for its intended use in cell culture.

  • Gas Permeable – Water Impermeable

    The Evolve bags are gas permeable, and provide a high rate of oxygen and carbon dioxide transfer to cells under culture with low water vapor loss.

  • Needle-Free

    Swabable, needle-free valves are provided on every bag to preserve sterile access and reduce the chance of needle sticks. These swabable ports maintain the culture’s sterility through multiple actuations.

  • Closed System Processing

    Evolve bags are a closed system, which will reduce the possibility of contamination. Manifold sets and tube configurations allow for cell processing via SCD weldable tubing.

ML41.R07

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Product Use

Product Code

Product Description

Case Qty

EV120+F-M12 EVO Bag, 70-120ml Fill Volume, with luer connections and needle free valve with separate female to male tube set with 12cm of tubing 20
EV1000N EVO Bag,100 -500ml Fill Volume, with one male luer with cap, two female luers  with caps, and a needle-free injection port 12
EV3000N EVO Bag, 500-2000ml Fill Volume, with one male luer with cap, two female luers with caps, and a needle-free injection port 12

In cell culture - what is the benefit of using a closed system?

Bags create a closed system that reduces the possibility of contamination. Swabbable needle-free valves are provided that provide repeated sterile access (and prevent needle sticks). Our cell culture bags have a high optical transmission that allows for the inspection of contents without risking contamination of the culture. The bags are gas-permeable and provide high rates of oxygen transfer to cells under culture. Additionally, water permeability is very low, so water loss is negligible and humidified incubators are not required.

What are the dimensions of a particular Evolve bag?

EV120 ~ 10cm x 13cm
EV1000 ~ 17cm x 20cm
EV3000 ~ 21cm x 39cm

What is the expiration date of Evolve Products?

4 years from sterilization

I have a problem with a product, what is the complaint procedure?

If you encounter any issues with an OriGen Biomedical product and wish to file a complaint, we encourage you to do so ASAP. Please contact the OriGen head office or reach out to your dedicated sales representative for assistance. To facilitate our investigation and resolution process, we kindly ask that you retain both the product and its packaging. This will aid us in conducting a thorough analysis of the matter. All complaints will be acknowledged, and OriGen will follow up as appropriate during the investigation. Your feedback is invaluable to us as we strive to maintain the highest standards of quality and customer satisfaction.

Where can I find the Instructions for Use (IFU), Certificate of Analysis (CoA), Certificate of Conformance (CoC), and/or Safety Data Sheet (SDS) for the product I received?

OriGen has transitioned to using Electronic Instructions for Use (eIFUs). They are available at ifu.origen.com. Your CoA or CoC will be included with your original shipment box and can also be accessed through the Client Login. If you do not have a current Client Login, you will need to register for an account to access these documents.

How do I report an adverse event?

Any adverse event related to the device should immediately be reported to OriGen Biomedical or its authorized distributor, the competent local authority, and any other regulators as required by telephone, fax, or letter. This includes an incident or risk of a serious incident liable to result in, or to have resulted in, the death or serious deterioration in the health condition of a patient or user. All complaints should be accompanied by the name(s), reference(s), and batch number(s) of the component(s) and the name and address of the claimant, the nature of the complaint with as much detail as possible, and the indication of a requested response. OriGen Biomedical is located at 2215 Grand Avenue Parkway, Austin, TX, USA 78728-3812 (Tel: +1-512-474-7278, Email: sales.us@origen.com).

What is the difference between the Evolve Bag and the PermaLife bag?

Evolve bags are made from EVO, a proprietary copolymer, while PermaLife bags are made of FEP (fluorinated ethylene propylene). Evolve bags and PermaLife bags are available in multiple sizes. PermaLife bags can be cryopreserved, but Evolve bags cannot.

Can the Evolve Bag be centrifuged?

OriGen has not validated the use of Evolve bags in centrifuges.

What do the product codes mean?

Please see our product code definitions located here.

How do I obtain pricing?

Please contact your OriGen Account Manager (USA, Canada, or UK), your local distributor (international), or OriGen Biomedical if you are unsure of who to contact through the form here or by calling +1-512-474-7278.

What are OriGen's lead times?

When available, most orders ship within 2-3 business days. Some international orders may take 3-5 business days for shipment. Special order items will always be manufactured to order, with minimum quantities and a lead time.

What applications could Evolve Cell Culture Bags be used in?

OriGen does not indicate the Evolve bags for specific applications. The patient group is not a factor in the clinical use of the CryoStore Freezing Bags as the products are not intended for use with any specific patient population, disease state, clinical stage of disease, nor patient condition. Our existing customers commonly use the Evolve bags for:
• Biopharmaceutical Production
• Stem Cell Expansion and Differentiation
• Vaccine Development
• Drug Discovery and Screening
• Cell Therapy Manufacturing
• Virology Research
• Tissue Engineering

What is the recommended storage for Evolve Bags?

Store in a cool, dry area (typically 15°C – 30°C), but users should define and validate their specific space and assign ranges suitable for their conditions.

How can I remove air bubbles from the Evolve Bag?

OriGen recommends connecting a syringe to the needle-free valve to remove the air from the bags. Customers can gently manipulate and massage the bag to move the air to the top of the bag near the ports. The bag may need to be tilted to get the air to move near the port and then the user can pull out the air using the syringe.

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