UA-44035381-1
  • Stericheck Canisters

Stericheck Canisters

mdi Stericheck is a presterilized, nontoxic, non-pyrogenic, ready to use, sterility testing device. The twin canisters along with the tubing is packed individually in a blister pack.

The Stericheck device has been validated for microbial retention, microbial recovery, and sterility.

Type Description
Stericheck SVP1

Stericheck device for Small Volume Parenterals - Vials (Liquid).Connection: Dual vented needle with PVC tubing

Stericheck SVP2

Stericheck device for Ampoules and Collapsible bags.Connection: Single needle with PVC tubing and a separate air vented needle for venting media or rinse bottles during transfer steps.

Stericheck SVP3

Stericheck device for Small Volume Parenterals - Vials with soluble powder.Connection: Single vented needle with single tubing to transfer sterile diluent to the vial for dissolving the powder and a double needle with double tubing for transferring the resulting solution.

Stericheck SVP4

Stericheck device for Small volume Parenterals - MIni vials and Cartridges.Connection: Single needle with single tubing to transfer sterile sample to a sterile pooling bottle, and a double vented needle with double tubing for transferring the pooled sample.

Stericheck PC

Stericheck device for Plastic containers.Connection: Single unvented, non-coring needle tip, PVC tubing and a separate air vented needle.

Stericheck LVP

Stericheck device for Large Volume Parenterals in glass bottles.Connection: Single vented needle with PVC tubing.

Stericheck PFS

Stericheck device for pre-filled syringesConnection: Specially designed adapter for sterility testing of the syringe's needle as well as its product . Testing of both inside and outside of the needle is ensured by the liquid flow pattern.

SVP Dilutor

SVP Dilutor for antibiotics and difficult to dissolve powders.Connection: Single needle with expansion chamber and vent. Double needle with PVC tubing.

Construction
Membrane Cellulose Nitrate, Nylon-66, PVDF
Pore size 0.45µm
Canisters SAN
Tubing PVC
Dimensions (Canisters) 51mm D x 120mm H
Operational
Max. Operating Temperature 35 °C continuous
Max. Differential Pressure 45psi
Sterilization Gamma, EO sterilized
Shelf Life
3 Years after EO sterilization2 Years after gamma sterilization
Water Flow Rate > 0.3lpm @ 10psi at 25°C
Assurance
Bacterial Retention Retains >107 organisms/cm² of Serratia marcescens ATCC 14756 challenge
Quality Management System ISO-9001:2008 Certified
Sterility Passes sterility as per USP
Microbial Recovery Tested for microbial recovery with 6 USP specified organisms
Package Integrity Passes as per ASTM F1929-98

Type
Type Code
PVDF Cellulose Nitrate Nylon-66*
Stericheck SVP1 SV1V SV1C SV1N
Stericheck SVP2 SV2V SV2C SV2N
Stericheck SVP3 SV3V SV3C SV3N
Stericheck SVP4 SV4V SV4C SV4N
Stericheck LVP SLVV SLVC SLVN
Stericheck PC SPCV SPCC SPCN
Stericheck PFS SPFV SPFC SPFN
Size
Dia Code
47mm 09
Pore Size
Pore Size Code
0.45µm 02
XX
XX
Sterility
Code
EO Sterilized 2
Gamma Sterile 3
Pack Size
Pack Size Code
10 02

      * Stericheck Devices with Nylon membranes are available as EO sterilized Only

    Example :

SV1C 09 02 XX XX 2 02

For SVP Dilutor pack of 20:

EO Sterilized: SVPDXXXXXXXX209                                             Gamma Sterilized: SVPDXXXXXXXX309

Brochure/Leaflet Download
Certificate of Quality Download

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