r Fluid Technology Solutions Validation guide summary

1. introduction 2. Conditions of use 1 introduction 4 Materials, manufacturing and regulatory compliance statements a. Compliance declaration summary 5 Compendial and non compendial testing g. ISO 10993-11 (injection test toxicity) 6 Total Organic Carbon (TOC) Our factory in Seaford, Delaware USA produces a range of BioPure products including high purity silicone hose, gaskets and tubing for use in biopharmaceutical and pharmaceutical manufacturing. The facility contains 3,000 square feet of cleanroom manufacturing. BioPure silicone transfer tubing is manufactured in ISO 14644-1 Class 7 cleanrooms...

Table 1: List of compliance statements for BioPure silicone transfer tubing and substances not found in the processing of/ or raw materials for BioPure silicone transfer tubing BioPure silicone transfer tubing has passed a number of compendial and ISO testing, a summary of the results are disclosed within. the cell cultures was replaced by extracts of silicone 5e ISO 10993-6 Biological evaluation of transfer tubing or c°ntr°l article. medical devices, implantation The cell cultures were incubated for 48 hours at 37±1C (98.6F±33.8F). Biological reactivity was evaluated by a photo spectrometer...

Table 3: List of physiochemical tests that form EP 3.1.9 - Silicone elastomer for closures and tubing Appearance of Solution Less intense than the color The Sample Solution is not more intensely PASS Color standard colored than the color standard 5f 10993-10 Biological evaluation of medical devices, irritation The intracutaneous test is designed to evaluate local responses to the extracts of silicone transfer tubing following intracutaneous injection. Silicone transfer tubing is extracted using 0.9% sodium chloride for injection, cottonseed oil, 1 in 20 ethanol in NaCl or polyethylene glycol...

7. Extractables testing Sections of BioPure silicone transfer tubing were subjected to extraction in multiple solvents at controlled temperatures. Extractions were performed using four (4) solvents: (1) purified water; (2) 50% (v/v) ethyl alcohol in water (50% EtOH); (3) 0.5 N Sodium Hydroxide (NaOH); and (4) 0.1 M Phosphoric acid (H3PO4). Extractions were performed under aggressive conditions of 40 ± 2 º C for 24± 2 hours and 21 ± 1 days. The resulting extracts were analyzed by a variety of analytical techniques, to identify and quantify materials that may have migrated from the product contact...

Fluid Technology Solutions BIOTECHNOLOGY AND PHARMACEUTICAL SOLUTIONS Watson-Marlow Fluid Technology Solutions Watson-Marlow Fluid Technology Solutions supports its customers locally through an extensive global network of direct sales operations and distributors Copyright © 2022 Watson-Marlow Fluid Technology Solutions Validation guide summary: BioPure platinum-cured silicone transfer tubing HB0833 Issue 2 Disclaimer: The information contained in this document is believed to be correct but Watson-Marlow Limited accepts no liability for any errors it contains and reserves the right to alter specifications...