Validation summary guide MARLOW r Fluid Technology Solutions

Executive Summary This is the summary validation guide for disposable PEI nozzles. 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/

Filling nozzles - disposable PEI 1000 are manufactured by Voss Industry and Medical A/S, Denmark for use in WMArchitect filling assemblies. These WMArchitect filling assemblies are made to optimized specifications (specific to Flexicon systems) at our BioPure manufacturing facility in Havant, UK. This guide relates to filling nozzles - disposable PEI 1000 which from this point will be referred to as PEI nozzles. PEI nozzles are suitable for use according to the conditions in Table 1. Table 1. Conditions for manufacturing, sterilisation, working and storage. Liquid Filling CZSEUTF Snology MARLOW...

4b. USP <85> Bacterial endotoxins 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)._ Results: <0.005 EU/mL (irradiated), 0.005 EU/mL (autoclaved) <0.25 EU/mL (endotoxin limit of 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...

• Inductively Coupled Plasma-Mass Spectrometry (ICP/MS) to identify elemental impurities_ Results: Extractables were indicative of materials of construction. Validation testing services can provide further information in the evaluation of extractable data for risk assessment purposes, please see section 5. Test samples were analysed for the following using DI-GC-MS: • N-Nitrosodimethylamine (NDMA) • N-Nitrosomethylethylamine (NMEA) • N-Nitrosodiethylamine (NDEA) • N-Nitrosodipropylamine (NDPA) • N-Nitrosodibutylamine (NDBA) • N-Nitrosopiperidine (NPIP) • N-Nitrosopyrrolidine (NPYR) • N-Nitrosomorpholine...

Filling nozzles- disposable PEI 1000 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]. Liquid Filling

WATSON MARLOW T Fluid Technology Solutions BIOTECHNOLOGY AND PHARMACEUTICAL SOLUTIONS Liquid Filling Process Pumps wm architect 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 responsibility to ensure...