AcuFlo™ Accurate Pump PCS Tubing
AcuFlo™ accurate pump PCS Tubing is specially designed for biopharmaceutical applications where accuratedispensing and consistent flow rates are required.
AcuFlo™ tubing has well finished and extremely smooth fluid contact surface that helps in consistent flow rates without any particle generation.
- Accurate Dispensing: AcuFlo™ accurate pump PCS tubing comply with USP<1151> PHARMACEUTICAL DOSAGE FORMS
- No Drip Formation: AcuFlo™ accurate pump PCS Tubing do not show any drip formation at different fill volumes with a pause time of 30 seconds with water.
- No Spallation : No Particle Generation: AcuFlo™ accurate pump PCS Tubing comply with USP <788> for Particulate Matter in Injections and USP <790> for Visible Particulate in Injections over 4 hours of pumping.
- Consistent Flow Rates: AcuFlo™ accurate pump PCS Tubing offers consistent flow rates.
Single use disposable filling lines for pumping and accurate fluid transfer from surge bags to filling needles
| Operational | |
| Sterilization By Irradiation | up to 50 kGy |
| 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 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: AFSA016048AXX01, 2 rolls
| File Type | Download |
|---|---|
| Brochure | Download |
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