AseptiBag™ LT
MDI AseptiBag™ LT single-use storage and transfer systems are designed for cold chain applications in biopharmaceuticals. These systems are suitable for low-temperature storage of up to -80°C, as well as multiple freeze-thaw applications involving high-value drug substances and process intermediates.
MDI AseptiBag™ LT systems are made from low-extractable ULDPE film and provide robustness to ensure integrity at sub-zero temperatures during freezing, storage, transportation, and thawing.
MDI AseptiBag™ LT systems are used for long-term low-temperature storage of:
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Process intermediates
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Drug substances
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Vaccine active raw materials (ARM)
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Monoclonal Antibodies (mAbs)
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Recombinant proteins
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Compatible with long-term storage at temperatures up to -80°C
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Withstands multiple freeze-thaw cycles
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Very low extractable profile
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High strength and flexibility
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High transparency
| 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 |
| Film | Ultra-Low Density Polyethylene (ULDPE) |
| Operating Temperature | -80°C to 45°C |
| Storage Temperature | Up to -80°C |
| Sterilization | Gamma sterilizable up to 50 kGy |
| 100% Integrity Tested | Each system tested to comply with validated Acceptable Integrity Test Specifications |
| Pressure Endurance | Validated to endure operating and burst pressure with liquid for user and product safety |
| Temperature Endurance | AseptiBag™ LT systems are validated to endure wide temperature conditions which may be encountered during use |
| Bioburden Testing | Bioburden is tested as per ISO 117 37-1 and assured to be <1000 cfu/bag |
| Biosafety | Passes Biological Reactivity test, In-Vivo, as per USP <88> for Class VI plastics. Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>. |
| Extractables | Extractables/leachables from bags, used at various stages of a biopharmaceutical manufacturing process, will add on and may impact the impurity profile of the desired product |
| Particulate Matter | AseptiBag™ LT systems are validated for particulate matter in injections as per USP <788> and visible particulates in injections as per USP <790> |
| Sterility Assurance | mdi AseptiBag™ LT systems are sterilized by gamma irradiation to provide a sterility assurance level of 10-6. The sterilization process has been validated as per ISO 11137-2 which includes dose verification, dose mapping and quarterly dose audit
The sterilization dose of 25 kGy has been substantiated through careful definition of the test samples, bio-burden testing of multiple lots of the selected test samples, calculation of verification dose and sterility testing. |
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> |
For 3 mL Bags
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Example :
| ABLT | U | M | X | XXX | X | X | 3 | 02 |
For 10 mL and 250 mL Bags
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Example :
| ABLT | 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 :
| ABLT | C | J | J | N | XX | X | X | 3 | 02 |
| File Type | Download |
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| Datasheet | Download |
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