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.
Non Coring Needle Design
– To prevent blockage by rubber particles from vial bungs
Pre-installed Color Coded Clamps
– For easy identification and clamping at both ends of the tube
Raised Transparent Vent
– To minimize chances of fluid logging and subsequent obstruction of air flow
– For easy visibility in case of accidental fluid logging
Special ‘L’ shaped Flow Directors
– To minimize frothing, specially with viscous fluids
Tough Membrane
– Withstands inadvertent back pressure
– Available with three different polymeric tough membranes
Archivable Chemical Indicator
– In each Stericheck pack as evidence of EO gas sterilization
Easy to Peel off, Impervious Blister Pack Cover
– For radiation sterilized Stericheck devices to prevent ingress of H O during isolator disinfection
Customized Needle Connections
– For specific customer needs such as mini vials and cartridges in biopharmaceuticals
| 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 |
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| 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 | ||
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* 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
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