Sterility Assurance

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Date

Sterilization Support Services

A. ANSI/AAMI/ISO 11137/TIR27 Radiation Qualification (Protocol is required)

Final price may vary based on bioburden volume, samply size and/or irradiation charges. See sterility test section for additional assistance. Ask Dynatec Protocol for addiitonal assistance and for details of their “TURNKEY” process. **Includes Bioburden a
 
SIP Preparation (SIP-P)
SIP Qualification (SIP-Q)
Irradiation Dose Service (AUDT)
**VDmax Qualification (VDQ)
**VDmax Audit (VDA)

B. Dosing

Ethylene Oxide (DOSE-E)
Heat (DOSE-H)
Radiation (DOSE-R)
Ultra-Violet (DOSE-UV)

C.

Ethylene Oxide Validation Studies (EVS)

D.

Dry Heat or Steam Validation Studies (DSV)

E.

Irradiation Validation Studies (IVS)

F.

Medical Device Disposal (MDD)

G.

Reusable Medical Device Validation AAMI/TIR No.12-1994

Sterility Test: Testing conducted in accordance with AAMSI/ISO Standards or USP Guidelines.

A.*Price based on annual volume

Spore Strip Immersion in glassine (Media reqired* 15mL)(STS)
Spore Strip Immersion Weekend (Media reqired* 15mL)(STS-W)
Self Contained Biological Indicators (STI)
Self Contained Biological Indicators* 4 hour release (SSS)
Cycle Validation (Media required* 15 mL) (STS, SEQ)

B.

Product Immersion (STP)
Product Immersion (Weekend) (STP-W)

C. Bacteriostasis / FungistasisServices are conducted in accordance with U.S.P. Guidelines utilizing A.T.C.C. acknowledged test microorganisms.

Aerobic (Media Required* 40 mL)(STBF-1)
Aerobic (Media Required* 100-400 mL)(STBF-2)
Anaerobic (Media Required* 40 mL)(STBF-3)
Anaerobic (Media Required* 100-400 mL)(STBF-4)

D. Product Inoculation, based on suspension of 106 (SPI-1)

Product Inoculation, based on suspension of 106 (SPI-1)
 

Recovery Studies

Product (MRP)
Biological Indicator (E.O.) (MRB)
Biological Indicator (Steam)(MRS

Report Fees

A. Single formal reportOne formal report is included per test request. Additional reports are available.

One formal report (AR)

B. Fax documents and e-mail are available as follows:

1-2 pages (FX-1)
3-4 pages(FX-2)
5 and up (FX-3)

C. Weekend Fax

Weekend Fax (FXW)

Email

Electronic mail administrative service charge

Courier Services

B.I. Pick-up/delivery (C-1)
Other (C-2)
Additional (weekend) (C-W)

Product

On-Site Sampling Requested?

Yes
No
N/A

Chain of Custody to Accompany Samples? (EPA Requirement)

Yes
No
N/A

Professional Organizations