/ 705 Front Street
Toledo, OH 43605
Phone: 419-693-5307 Fax: 419-691-0418

Sample Submission Form(Use one form per sample)

Client #: / Purchase Order #: / LexaMed Lab #:
Company: / Results: / STAT (extra fee) / Phone / Fax / Email
Address:
Samples Received on: / Cold Packs / Ice / Room Temp
Contact Person:
Phone: / Fax: / Storage Conditions: / Room Temp / Refrigeration / Freezer
Email: / (Product will be discarded after testing unless otherwise requested)
# Samples Supplied: / Sterile / Non-Sterile
Sample Description (This I.D. will be typed on the final report)
Part #: / Lot #: / Batch #:
Test Article is a: / Medical Device / Pharmaceutical / Combination Device / Other:
Is the test article FDA regulated?: / Yes / No / Is testing for: / R&D / FDA Submission / (Type: / )
List any acceptance specifications if applicable:

Please perform the following tests:

General Microbiology / Bioburden / Chemistry
Environmental Monitoring Plates / Bioburden Method Validation- Spore Inoculation / pH
Total Plate Count – Direct Plating / Bioburden Method Validation– Exhaustive / Conductivity
Total Plate Count –Membrane Filtration / Total Aerobic / Hydrogen Peroxide Assay
Organism ID – Gram Stain / Total Aerobic Spore / Total Polyphenols Assay
Organism ID – Genus & Species / Total Anaerobic / UV analysis
USP <51> Antimicrobial Effectiveness / Total Fungi (Yeast and Mold) / HPLC analysis
USP <61> TAMC/TYMC – Suitability / Biological Indicator Tests / GC analysis
USP <61> TAMC/TYMC – Routine / USP BI Population Verification – 3 BIs / Bradford Protein Assay
USP <62> Test for Specific Org - Suitability / ISO BI Population Verification – 4 BIs / Hemoglobin Assay
USP <62> Test for Specific Org – Routine / D-value Steam Stumbo –Murphy / Glucose Assay
Water Testing –TPC - Direct Plating / D-value Steam Spearman-Karber / Detergent Residual UV Analysis
Water Testing – TPC - Membrane Filtration / D-value Steam Limited Spearman-Karber / AOAC Testing
Water Testing - Fecal Coliform / z-value Steam Stumbo-Murphy / Use Dilution Aqueous or Water
Water Testing – Total Coliform / z-value Steam Spearman-Karber / Soluble Disinfectants-Presumptive
Water Testing – Total E Coli / z-value Moist Heat / Use Dilution Aqueous or Water
Particulate Analysis – Microscopic Count / Cytotoxicity / Soluble Disinfectants-Confirmatory
USP Purifed Water Testing / MEM Elution – ISO Method / Container Closure Integrity
Sterility Testing / MEM Elution – USP Method / Microbial Aerosol Challenge
Aseptic SIP Preparation / Agar Overlay – ISO Method / Microbial Ingress Challenge
Bacteriostasis/Fungistasis SCD FTM / Agar Overlay – USP Method / Dye Ingress Challenge
Membrane Filtration / EO Residuals / Package Integrity Testing
Product Immersion – Qty: ___ / Ethylene Oxide (EO) / Burst Test
Biological Indicators – Qty: ___ / Ethylene Chlorohydrin (EC) / Dye Penetration
Media Fill Sterility / Ethylene Glycol (EG) / Seal Peel
LAL Gel Clot Testing / Extraction Method: / Material Barrier Testing
Device / Simulated Use Temp__Time__ / BFE Test
Liquid Sample / Exhaustive (24 hr intervals) / Synthetic Blood Penetration
Inhibition / Enhancement Testing – 1 lot / TCL required ;Surface Area ____ / Hydrostatic Pressure Test
Inhibition / Enhancement Testing – 3 lot / Spray Impact Test
Other Tests Not Listed:
Special Instructions:

Client Signature: Date:

For Laboratory Use Only
Date Received______Received Via ______Logged in by______
______

CS201SS:R13:022114