AseptiBag™ ULO+
Many biopharmaceutical drug substance/products, process intermediates and also chemically defined media (for mammalian cell culture) are light sensitive.
Exposure of light sensitive drugs to UV or visible light, may result in degradation of drug molecules that may impact patient safety. In case of light sensitive media, degradation of vital ingredients such as vitamins can reduce process efficiencies in mammalian cell expression systems.
MDI AseptiBag™ ULO+ systems are specially designed to provide validated and reliable storage and transfer solutions for light sensitive media as well as drugs for biopharmaceutical processes.
The MDI AseptiFlex™-T+ Film has a UV and light obstructing layer, co-extruded with the outer barrier layer, which minimizes transmission of light within the wavelength range of 200 nm to 780 nm.
AseptiBag™ ULO+ are designed to protect light sensitive fluids with a unique layer for minimizing UV and light transmission. These bags have been tested for transmittance of UV (200nm – 400 nm) as well as visible light (400nm-780nm) using a spectrophotometer with a wavelength accuracy of + 0.1nm.
The following table show the comparison between transmittance of UV and visible light with standard AseptiBag and AseptiBag ULO+.
| Bag Type | AseptiBag™ | AseptiBag™ ULO+ | |
| Transmittance (%) | |||
| UV Light | <250nm | > 4 % | 0.08 % |
| 250 nm – 400 nm | > 46 % | ||
| Visible Light | 400 nm – 780 nm | > 70 % | 0.008% |
For validated and reliable storage and transfer solutions for:
- Life sensitive drugs
- Chemically defined proprietary media for mammalian cell culture
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| Available Sizes | 3 mL, 10 mL, 50 mL, 100 mL, 250 mL, 500 mL, 1 L, 2 L, 3L, 5 L, 10 L , 20 L and 50 L | ||||||||||||||||||||||||||||||||||||||||||
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| Storage Temperature | -20°C to 45°C | ||||||||||||||||||||||||||||||||||||||||||
| Materials of Construction | |||||||||||||||||||||||||||||||||||||||||||
| Bag Film | AseptiFlex-T film | ||||||||||||||||||||||||||||||||||||||||||
| Connection Ports | Polycarbonate | ||||||||||||||||||||||||||||||||||||||||||
| Clamps | Polyester | ||||||||||||||||||||||||||||||||||||||||||
| Tubing | Platinum cured silicone | ||||||||||||||||||||||||||||||||||||||||||
| Dimensions | |||||||||||||||||||||||||||||||||||||||||||
| Dimensions |
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| Specifications | |||||||||||||||||||||||||||||||||||||||||||
| Fill Volume | MDI AseptiBag ULO+ are designed for an overfill volume of > 10% over the specified bag size (volumes). | ||||||||||||||||||||||||||||||||||||||||||
| Assurance | |||||||||||||||||||||||||||||||||||||||||||
| 100% Integrity Tested | Each AseptiBag ULO+ is tested for integrity to comply with validated Acceptable Integrity Test Specifications. | ||||||||||||||||||||||||||||||||||||||||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> | ||||||||||||||||||||||||||||||||||||||||||
| Bioburden | Device bioburden is tested as per ISO 117 37-1 and assured to be <1000 cfu/bag. | ||||||||||||||||||||||||||||||||||||||||||
| Fiber Release | Passes microscopic test for fibers | ||||||||||||||||||||||||||||||||||||||||||
| Particle Release | Complies with USP <788> test for particulate matter in injections | ||||||||||||||||||||||||||||||||||||||||||
| Endotoxin Testing | Aqueous extracts exhibit < 0.125 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test | ||||||||||||||||||||||||||||||||||||||||||
| Sterilization | Gamma Sterilizable upto 50 kGy | ||||||||||||||||||||||||||||||||||||||||||
| Extractables |
Extractables/leachables from sterile containers, used at various stages of a biopharmaceutical manufacturing process, will add on and may impact the impurity profile of the desired product. The Extractable study was performed as per Biophorum Best Practices Guide for Extractable Testing of Polymeric Single-Use Components used in Biopharmaceutical Manufacturing.
AseptiBag ULO+ systems are validated to exhibit very low extractables under harsh extraction conditions.
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| Sterility | The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6 | ||||||||||||||||||||||||||||||||||||||||||
| Package Integrity | AseptiBag ULO+ systems are double packed in polybags to ensure package integrity during transit as well as to prevent contamination while transferring to clean room assembly or process areas. | ||||||||||||||||||||||||||||||||||||||||||
| Biosafety | Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88>. Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>. | ||||||||||||||||||||||||||||||||||||||||||
For 3 mL Bags
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Example :
| ABUP | U | M | X | XXX | X | X | 3 | 02 |
For 10 mL and 250 mL Bags
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Example :
| ABUP | B | M | L | XXX | X | X | 3 | 02 |
For 500mL to 50L Bags
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*Female Luer Lock and Male Luer Lock are available only for 500mL, 1L and 2L bag sizes
Example :
| ABUP | C | J | J | N | XX | X | X | 3 | 02 |
| File Type | Download |
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| Datasheet | Download |
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