Accusil Platinum-cured silicone tubing

Product catalog summary

Introduction
Accusil™ platinum-cured silicone tubing is crafted from USP class VI raw material in an ISO 14644-1 Class 7 cleanroom, ensuring high quality and compliance with various tests. It is compatible with Flexicon peristaltic technology, providing precise dispensing. Key features include laser traceability, cleanroom manufacturing, double bagging for contamination protection, and suitability for gamma irradiation.

Conditions of Use
Accusil tubing can be sterilized via gamma irradiation up to 50kGy or autoclaving at 121°C for up to 60 minutes. It functions effectively within a temperature range of –20°C to 80°C.

Chemical Compatibility
A general guide on chemical compatibility is available on the Watson-Marlow Fluid Technologies Solutions website.

Materials, Manufacturing, and Regulatory Compliance

Materials of Construction: Made of polydimethylsiloxane (PDMS).
Manufacturing Environment: Produced in an ISO 14644-1 class 7 cleanroom under ISO 9001 quality management.
Country of Origin: Manufactured in the UK.
Compliance: Free from substances like glycerin, animal-derived content, melamine, phthalates, BPA, latex, and heavy metals.
REACH and RoHS: Compliant with REACH and RoHS regulations.
Storage Conditions: Store in a cool, dry place away from sunlight, maintaining original packaging when possible.

Compendial and Non-Compendial Testing
Accusil has passed various tests including USP <87>, USP <88>, ISO 10993 series, and European Pharmacopoeia 3.1.9, confirming its biocompatibility and safety.

Extractables
Accusil tubing was tested for extractables using advanced analytical techniques, confirming the materials of construction and ensuring safety for use.

Conclusions
Accusil tubing meets numerous pharmacopoeial and ISO standards, ensuring its suitability for use in critical applications. Full compliance statements and test reports are available upon request from the WMFTS website.

Specifications and Test Results

Appearance of Solution: Clear with a turbidity of 0.68 NTU, passing the evaluation criterion of 3 NTU.
Acidity: Requires 2.5 ml of 0.01M NaOH to change to blue, passing the maximum limit.
Alkalinity: Requires 1.0 ml of 0.01M HCl to change from yellow to red, passing the maximum limit.
Reducing Substances: Difference between sample and blank is 0.3 ml, below the maximum limit of 1.0 ml, passing.
Relative Density: Measured at 1.18, within the acceptable range of 1.05 to 1.25, passing.
Volatile Matter: Measured at 0.20%, below the maximum limit of 2% for Pt cured, passing.
Mineral Oils: No fluorescence observed, less than the 1 ppm standard, passing.
Substances Soluble in Hexanes: Measured at 10.3 mg, below the maximum limit of 15 mg (or 3%), passing.
Phenylated Compounds: Maximum absorbance is less than 0.01 A.u., below the limit of 0.4 A.u. between 250 and 340 nm, passing.
Platinum: Less colored than the Pt reference (30 ppm), passing.

Disclaimer
The document states that the information is believed to be correct, but Watson-Marlow Flexicon A/S accepts no liability for errors and reserves the right to alter specifications without notice. It also warns that these products are not designed for use in patient-connected applications.

Company Information
Watson-Marlow Fluid Technology Solutions supports its customers through a global network of direct sales operations and distributors. It is a part of Spirax-Sarco Engineering plc.

Catalog excerpts

Accusil Platinum-cured silicone tubing-1

r Fluid Technology Solutions Validation guide summary

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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%....

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Accusil Platinum-cured silicone tubing-3

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...

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Accusil Platinum-cured silicone tubing-4

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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MARLOW Solutions BIOTECHNOLOGY AND PHARMACEUTICAL SOLUTIONS Flexicon Liquid Filling 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 wmfts.com/global Copyright © 2023 Watson-Marlow Fluid Technology Solutions Validation guide summary: Flexicon, Accusil Platinum-cured silicone tubing HB0742 Issue 8 The information in this document is believed to be correct, but Watson-Marlow Flexicon A/S accepts no liability for any errors it contains, and reserves the...

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Accusil Platinum-cured silicone tubing

Accusil Platinum-cured silicone tubing

Catalog excerpts

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