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#4 PES 4 INCHES IN CM ISO#

#4 PES 4 INCHES IN CM ISO#

This product meets the specifications of ISO 10993-5 Tests for in vitro cytotoxicity and USP Biological Reactivity, in vitro. This product is non-cytotoxic per USP Cytotoxicity MEM Elution Test.Ĭomponent materials meet the criteria for Class VI testing based on USP Biological Reactivity, in vivo. Device integrity was maintained after in-line steam of 10 forward and 5 reverse cycles of 30 minutes at 135° C.ĭevice integrity was maintained after gamma irradiation up to 40 kGy and 3 wet autoclave cycles of 60 minutes at 123° C.ĭevices tested and meet requirements of USP for large volume parenterals.Ĭomponent Materials meet the criteria of the USP Reactivity Test for Class VI Plastics.

May be autoclaved for 1 cycle at 123° C for 60 min.ĭevice integrity was maintained after 25 autoclave cycles of 60 minutes at 128° C.

This product exhibits less than 500 ppb TOC per USP and less than 1.3 µS/cm at 25☌ per USP after autoclaving and purified water flush of 15 mL.Īfter sterilization and a controlled water flush of 20 L per 10-inch device, sample exhibited ≤500 ppb TOC per USP and ≤1.3 μS/cm per USP at 25☌. The 1.2/0.45 µm filter typically provides ≥ 6 log removal of Serratia marcescens based on ASTM ® D3863 and F838 methodology.Īqueous extraction from a sample contains, EP 2.6.14 and JP 4.01. The 1.2/0.2 µm nominal filter typically provides ≥ 6 log removal of Brevundimonas diminuta based on ASTM ® F838 methodology.

Convenient 24/7 access to up-to-date product information.Ĭapped vent with female Luer connection on inlet side of device.

Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.

Comprehensive documentation to support qualification, risk assessment and process optimization needs.

The Emprove ® Program complements the product portfolio through

1.2/0.45 μm Available Pore Sizes for Particulate Reduction.

For traceability and easy identification, each filter is marked with Each cartridge filter is supported by documentation to comply with regulatory requirements. Milligard ® PES filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO ® 9001 Quality Systems Standard and are shipped with a Certificate of Quality.

Gamma stable and available in single use assemblies Regulatory Compliance.

High thermal stability: compatible with steam-in place and autoclave sterilization methods.

Predictable scalability from small to production scale devices.

Validated bioburden reduction (1.2/0.2 μm nominal and 1.2/0.45 μm pore sizes only).

They can be used at different stages in a bioprocess production train enabling more efficient performance of sterile filters and protection of other unit operations. These membrane based filters can provide validated bioburden reduction in applications where sterilizing filtration is not required. Milligard ® PES filters are designed for effective bioburden control and reliable removal of particles from a broad range of fluid streams.