AseptiFlo™ PCS Tubing
mdi AseptiFlo™ Platinum Cured Silicone (PCS) tubing offers a reliable solution for fluid transfer and management in biopharmaceuticals processes.
- Single use assemblies for fluid transfer
- Tube and bag manifolds for aseptic sampling
| Specifications | |
| Hardness | 55 Shore A |
| Operational | |
| Sterilization By Irradiation | at 125°C for 30 minutes, 1 cycle |
| Shelf Life | MDI PCS 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 both PCS 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: AFST012044AXX01, 2 rolls
| Brochure/Leaflet | Download |