Validation summary guide f Fluid Technology Solutions

This is the summary validation guide for Platinum-cured silicone gaskets 5000 Series. Full test methods and results are available in the full validation guide, by filling in a request form on the website: https://www.wmfts.com/en/validation/request/

Watson-Marlow, Devens, Massachusetts, USA, produces 5000 series platinum-cured silicone gaskets used in biotechnology and pharmaceutical manufacturing. This guide relates to platinum-cured silicone gaskets 5000 series and from this point will be referred to as silicone gaskets. Silicone gaskets have the following features: • Full traceability with laser-etched lot numbering • Designed in accordance with ASME-BPE standards • Animal derived component free (ADCF) • Precision engineered for a smooth bore, contamination free, fluid path under clamping compression Silicone gaskets are suitable for...

Limulus Ameobocyte Lysate (LAL) gel clot test detects and quantifies endotoxin levels in samples. Test samples, negative control and endotoxin standards were extracted in LAL reagent water at room temperature for 60 minutes. LAL was added to samples and incubated at 37°C (98.6°F)._ Result is <0.25 EU/mL for water for injection. Passing USP <85> requirements. USP <87> determines the biological reactivity of cell cultures in response to samples. Test, positive and negative control samples were prepared at 37±1°C (98.6±33.8°F) for 24 hours. Biological reactivity was rated on a scale from Grade 0...

4f. USP <788> Particulate matter in injections This test determines the number of particulates measuring ≥10 μm and ≥25 μm present in the fluid pathway. Samples were immersed in low particulate water, extraction fluid recovered and particles measured. Results: 51 particles/device ≥10 μm and 47 particles/device ≥25 μm, passing USP <788> requirements. 4g. ISO 10993-4 Biological evaluation of medical device, interactions with blood The haemolysis test assesses the potential to cause rupture of erythrocytes (red blood cells) from indirect contact of samples. Phosphate buffered saline was added to...

4l. European Pharmacopoeia 3.1.9 Silicone elastomer for closures and tubing Extracts were prepared in accordance with the requirements of European pharmacopoeia, Chapter 3.1.9 Silicone elastomer for closures and tubing._ Results: All results pass E.P. 3.1.9 requirements. Samples were subjected to extraction in multiple solvents at controlled temperatures. The solvent extracts were analysed using: • High Pressure Liquid Chromatography- Diode Array Detector-Mass Spectrometry (HPLC-DAD/MS) to detect the presence of non-volatile and UV active compounds • Direct injection Gas Chromatography-Mass Spectrometry...

Silicone gaskets 5000 series have passed testing standards as summarised in this guide. For more information on quality and compliance information not stated in this guide, please contact your WMFTS representative or [email protected]. MARLOW Fluid

MARLOW f Fluid Technology Solutions BIOTECHNOLOGY AND PHARMACEUTICAL SOLUTIONS mnniF MARLOW Pumpsmmj MARLOW Tubing Flexicdn Liquid Filling Process Pumps single-use 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 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 without notice. It is the users...