UA-44035381-1
  • SteriCheck<sup>®</sup> 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 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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