r Fluid Technology Solutions Validation guide summary

4 Materials, manufacturing and regulatory compliance statements d. Compliance declaration summary 5 Compendial and non compendial testing 1. Introduction Flexicon’s Accusil™ platinum-cured silicone tubing is manufactured from a USP class VI raw material in an ISO 14644-1 Class 7 cleanroom operating within an ISO 9001 quality system. Accusil is compliant with a list of compendial testing as summarised in Section 5A. Accusil platinum-tubing has been exclusively designed for use in Flexicon peristaltic technology. When used together Accusil exhibits excellent dispensing accuracy of up to +/-0.5%....

Accusil Platinum-cured silicone tubing has passed a number of compendial and ISO testing, a summary of the results are disclosed within. Table 2: List of compendial and non compendial testing performed Animal Derived Content Heavy metals '-' denotes not present or not added Results: No reactivity (grade 0) was exhibited by the cell cultures when exposed to Accusil. Therefore Accusil is not cytotoxic and passed the requirements of USP biological reactivity tests. Results: Accusil extracts and implants showed no toxicity, therefore Accusil met the requirements of USP <88> Class VI biological reactivity...

Results: Accusil meet the requirements of ISO10993-11 guidelines for the systemic injection test. Results: The skin sites that were exposed to the test articles and negative control showed no signs of erythema or edema. Therefore Accusil is deemed not to contain any allergic potential. Results: Accusil extracts had an EU/ml value of <0.011 EU/cm2 which is comparable to the levels of endotoxin observed in water for injection. Results: Based on the evaluation criteria mentioned below, Accusil tubing meets the requirements of the USP <381> section physiochemical tests. Results: Based on the results...

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