Home » Products » Single Use Systems » MDI Tubings »
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
| Available Sizes | ||||
|---|---|---|---|---|
| Inner Diameter | Outer Diameter | Working Pressure | Burst Pressure | Wall Thickness |
| 1/8″ (3.2 mm) | 1/4″ (6.3 mm) | 30 psi | 90 psi | 1.5 mm |
| 1/4″ (6.3 mm) | 7/16″ (11.1 mm) | 27 psi | 80 psi | 2.4 mm |
| 1/4″ (6.3 mm) | 3/8″ (9.5 mm) | 20 psi | 60 psi | 1.6 mm |
| 1/4″ (6.3 mm) | 1/2″ (12.7 mm) | 40 psi | 120 psi | 3.2 mm |
| 5/16″ (7.9 mm) | 1/2″ (12.7 mm) | 23 psi | 70 psi | 2.4 mm |
| 3/8″ (9.5 mm) | 1/2″ (12.7 mm) | 17 psi | 50 psi | 1.6 mm |
| 3/8″ (9.5 mm) | 5/8″ (15.9 mm) | 23 psi | 70 psi | 3.2 mm |
| 1/2″ (12.7 mm) | 3/4″ (19.0 mm) | 20 psi | 60 psi | 3.2 mm |
| 3/4″ (19.0 mm) | 1″ (25.4 mm) | 15 psi | 45 psi | 3.2 mm |
| 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
| Catalog No. | Inner Diameter | Outer Diameter | Roll Length |
|---|---|---|---|
| AFIT031063AXX01 | 1/8″ (3.2 mm) | 1/4″ (6.3 mm) | 15 meter |
| AFIT063111AXX01 | 1/4″ (6.3 mm) | 7/16″ (11.1 mm) | 15 meter |
| AFIT063095AXX01 | 1/4″ (6.3 mm) | 3/8″ (9.5 mm) | 15 meter |
| AFIT063127AXX01 | 1/4″ (6.3 mm) | 1/2″ (12.7 mm) | 15 meter |
| AFIT079127AXX01 | 5/16″ (7.9 mm) | 1/2″ (12.7 mm) | 15 meter |
| AFIT095127AXX01 | 3/8″ (9.5 mm) | 1/2″ (12.7 mm) | 15 meter |
| AFIT095159AXX01 | 3/8″ (9.5 mm) | 5/8″ (15.9 mm) | 15 meter |
| AFIT127190AXX01 | 1/2″ (12.7 mm) | 3/4″ (19.0 mm) | 15 meter |
| AFIT190254AXX01 | 3/4″ (19.0 mm) | 1″ (25.4 mm) | 15 meter |
| File Type | Download |
|---|---|
| Brochure | Download |
Have questions or need assistance?
Our team is here to help! Contact us today, and we’ll get back to you as soon as possible.