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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
| Available Sizes | ||||
|---|---|---|---|---|
| Inner Diameter | Outer Diameter | Wall Thickness | Working Pressure | Burst Pressure |
| 0.8 mm | 4.0 mm | 1.60 mm | 13 psi | 40 psi |
| 1.2 mm | 4.4 mm | 1.60 mm | 13 psi | 40 psi |
| 1/16″ (1.6 mm) | 3/16″ (4.8 mm) | 1.59 mm | 33 psi | 100 psi |
| 1/8″ (3.1 mm) | 1/4 ” (6.3 mm) | 1.59 mm | 28 psi | 85 psi |
| 1/4 ” (6.3 mm) | 3/8″ (9.5 mm) | 1.58 mm | 16 psi | 48 psi |
| 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
| Catalog No. | Inner Diameter | Outer Diameter | Roll Length |
|---|---|---|---|
| AFSA008040AXX01 | 0.8 mm | 4.0 mm | 15 metre |
| AFSA012044AXX01 | 1.2 mm | 4.4 mm | 15 meter |
| AFSA016048AXX01 | 1/16″ (1.6 mm) | 3/16″ (4.8 mm) | 15 metre |
| AFSA031063AXX01 | 1/8″ (3.1 mm) | 1/4 ” (6.3 mm) | 15 meter |
| AFSA063095AXX01 | 1/4 ” (6.3 mm) | 3/8″ (9.5 mm) | 15 meter |
| File Type | Download |
|---|---|
| Brochure | Download |
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