AseptiFlex™ TPE Tubing
MDI AseptiFlex™ thermoplastic elastomer (TPE) tubing offers a reliable solution for process requiring fluid transfer and management.
AseptiFlex™ tubing are manufactured in certified clean rooms and have been validated to meet standardregulatory and functional requirements for critical applications ranging from aseptic sampling to sterilefilling of drug products.
- Heat weldable
- Heat sealable
- Uniform, smooth inner bore for efficient fluid flow
- Tube welding for sterile fluid pathway connections
- Tube sealing for sterile fluid pathway disconnections
- Single use bag and tubing assemblies
| Specifications | |
| Hardness | 60 Shore A |
| Operational | |
| Sterilization By Autoclave | at 125°C for 30 minutes, 1 cycle |
| Sterilization By Irradiation | up to 50 kGy |
| Shelf Life | MDI TPE tubing has a shelf life of 5 years. |
| Assurance | |
| Bioburden | Bioburden level is < 1000 cfu/device as per ISO 1737-1:2018. |
| Fiber Release | Passes test as per USP and comply with USFDA Title 21 CFR Part 210.3(b)(6) for fiber release. |
| Particle Release | Complies with USP <788> test for particulate matter in injections. |
| Indirect Food Additive | These PCS tubing meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520. |
| Endotoxin Testing | Aqueous extracts exhibit <0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85>. |
| Non Animal Origin | The materials used for manufacture of mdi tubing do not contain substance of animal origin as per EMEA/410/01 Rev. 03. |
| Extractables | Extractable profiles for TPE tubing are available as per BioPhorum Best Practices Guide for Extractable Testing of Polyemric Single Use Components used in Biopharmaceutical Manufacturing. |
| Sterility |
The gamma sterilization process for gamma sterilized tubing has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6.
|
| Package Integrity | MDI tubing with 15 M roll length are packed in double polyethylene bags to ensure package integrity during transit as well as to prevent particulate contamination. |
| 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>. |
To order, please specify the catalog number and quantity.
Example: AFTT031063AXX01, 2 rolls
| File Type | Download |
|---|---|
| Brochure | Download |
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