Stericheck Closed Sterility Test System: 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.

Construction
Pore size	0.45µm
Membrane	Cellulose Nitrate, Nylon-66, PVDF
Canisters	SAN
Tubing	PVC
Dimensions (Canisters)	51mm D x 120mm H
Operational
Max. Operating Temperature	35 °C continuous
Max. Differential Pressure	45psi
Water Flow Rates	> 0.3lpm @ 10psi at 25 C
Sterilization	Gamma, EO sterilized
Assurance
Bacterial Retention	LRV > 7 for Sr. marcescens
Bacterial Endotoxin	Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Extractables with WFI	Passes test as per USP
Oxidizable Substances	Within limits as specified in USP
Quality Management System	ISO-9001:2008 Certified
CE Certification	Comply with the requirements of Medical Device Directive, 93/42/95 (MDD) for Medical Device Class-1
USFDA	DMF Type V No. 15554

These devices are available with special needle connections for sterility testing of ampoules, vials, blood bags, dry injectables, pre-filled syringes, and I.V. Fluids with glass and plastic containers. Please refer ordering information table for ordering specific types


	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 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 syringes Connection: 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.

Type
Type	Code
	PVDF	Cellulose Nitrate	Nylon-66
Stericheck SVP1	SV1V	SV1C	SV1N
Stericheck SVP2	SV2V	SV1C	SV2N
Stericheck SVP3	SV3V	SV3C	SV3N
Stericheck LVP	SLVV	SLVC	SLVN
Stericheck PC	SPCV	SPFC	SPCN
Stericheck PFS	SPFV	SPFC	SPFN
SVP Dilutor	SVPD

Size
Dia	Code
47mm	09

Pore Size
Pore Size	Code
0.45µm	02

XX

Sterile/ Non Sterile
	Code
EO Sterilized	2

Pack Size
Pack Size	Code
10	02

SV1C

09

02

XX

2

02