MARLOW r Fluid Technology Solutions Validation guide summary

1. Introduction 2. Conditions of use 1 Introduction 4 Materials, manufacturing and regulatory compliance statements d. Compliance declaration summary Bioprene is a high performance thermoplastic elastomer tube manufactured from a USP Class VI raw material manufactured within an ISO9001 quality system. Bioprene is manufactured in an ISO 114644-1 Class 7 Cleanroom, is validated to USP Class VI*. Manufacturing is located at Watson-Marlow Ltd, Bickland Water Rd, Falmouth, UK, TR11 4RU. Bioprene tubing has the following key features: • Meets USP Class VI requirements* • Meets FDA regulations CFR 177.2600...

Table 1: Summary list of Compendial and non-compendial testing Results: No reactivity was exhibited by the cell cultures when exposed to Bioprene tubing. Therefore, they passed the requirements of USP 87 biological reactivity tests and have no cytotoxic potential. Results: Bioprene tubing extracts and implants showed no toxicity. Therefore, they passed the requirements of USP <88> biological reactivity tests. Results: Bioprene extracts had an EU/ml value of <0.009 EU/cm2 which is comparable to the levels of endotoxin observed in water for injection. Results: Per ISO 10993-4, Bioprene is considered...

5h ISO 10993-10 Kligman Maximisation Test The purpose of this test is to detect the allergenic potential of a test article. Bioprene was tested in accordance with ISO 1099310. Samples of Bioprene were extracted in USP 0.9% NaCl for injection and cottonseed oil at 70C for 24 hours and then injected intradermally. After two weeks, an additional topical application was introduced to the site of intradermal injections. Results: The sites that were exposed to the test articles and negative control showed no signs of erythema or edema. Therefore, Bioprene is deemed not to contain any allergy. 5i ISO...

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