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Our Services

MICROBIOLOGY
STERILITY TEST - DIRECT TRANSFER / PRODUCT IMMERSION
M100 Up to 50ml volume of media per vessel/tube, each  
M100A 100 to 250ml vessel, each  
M100B 300 to 500ml vessel, each  
M100C 600 to 1000ml vessel, each  
M100D above 1000ml vessel, each  
STERILITY TEST - FLUID PATHWAY
M200 For volumes up to 100ml product flush – devices, each  
STERILITY TEST - BIOLOGICAL INDICATOR (BI)
M102 Spore Strip Immersion in 15ml TSB, each  
M102A Self-contained BI test Indicators, each (one or two positive controls should be examined with each set of samples submitted / no cost)  
STERILITY TEST - MEMBRANE FILTRATION
M300 USP, 20 devices, fluid pathway up to 100ml  
M301 Individual Devices, up to 100ml fluid pathway
each additional fluid pathway flush,each
 
M302 Individual Sample  
STERILITY TEST - DEVICE VERIFICATION DOSE
ANSI/AAMI/ISO - B1 Method - 100 Product Dose Audit - Product Immersion
M400 Up to 50ml volume of media per vessel/tube  
M400A 100 to 250ml vessel  
M400B 300 to 500ml vessel  
M400C 600 to 1000ml vessel  
STERILITY TEST - DEVICE VERIFICATION DOSE
AAMI - VDmax Method - 10 Product Dose Audit
M450 Up to 50ml volume of media per vessel/tube  
M450A 100 to 250ml vessel  
M450B 300 to 500ml vessel  
M450C 600 to 1000ml vessel  
M450X Continuation/Confirmation Test on additional 10 samples  
ANSI/AAMI/ISO Radiation Sterilization Validation Program - Complete with Bioburden Validation, Overall Average Lot Determination and Dose Setting with Sterility Testing  

 

Methods Suitability Test (formerly known as Bacteriostasis and fungistasis test) is required by the U.S. Pharmacopeia as a means of validating the Sterility Test. This essential step should be conducted on all new products or materials initially submitted for testing and should be repeated periodically to assure continued compatibility with established testing procedures. Refer to page 4 for pricing schedules.

BIOBURDEN TESTING - POUR PLATE METHOD
M500 Aerobic bacteria only
1 - 9 samples, each
10+ samples, each
 
M501 Aerobic bacteria & fungi
1 - 9 samples, each
10+ samples, each
 
M502 Aerobic bacteria & spore forming
1 - 9 samples, each
10+ samples, each
 
M503 Aerobic bacteria & fungi & spores
1 - 9 samples, each
10+ samples, each
 
M504An Anaerobic bacteria in addition to any test above  
BIOBURDEN TESTING - MEMBRANE FILTRATION TECHNIQUE
M505 Aerobic bacteria only
1 - 9 samples, each
10+ samples, each
 
M506 Aerobic bacteria & fungi
1 - 9 samples, each
10+ samples, each
 
M507 Aerobic bacteria & spore forming
1 - 9 samples, each
10+ samples, each
 
M508 Aerobic bacteria & fungi & spores
1 - 9 samples, each
10+ samples, each
 
M509An Anaerobic bacteria in addition to any test above  
M509C Multiple, pooled small devices for one of above tests  

All of the above tests include positive and negative control testing of media and gram staining of the most predominate organism recovered.

MATERIALS CLASSIFIED AS HAZARDOUS ARE USED IN CONJUNCTION WITH THESE TESTS AND PRICES ARE REFLECTIVE OF THE SHIPPING AND WASTE DISPOSAL CHARGES INCURRED.

RECOVERY EFFICIENCY IS AN IMPORTANT FACTOR IN CALCULATING A TRUE AND MEANINGFUL BIOBURDEN LEVEL. EACH NEW MATERIAL OR PRODUCT CHANGE SHOULD UNDERGO BIOBURDEN VALIDATION/RECOVERY ANALYSES. A MINIMUM OF 3 TO 5 SAMPLES SHOULD BE SUBJECTED TO THE RECOVERY EFFICIENCY VALIDATION. VALIDATION INCLUDES RECOVERY-RATE-CORRECTION FACTOR, TOTAL BIOBURDEN SCREENING, INCUBATION GROW OUT TIME, AND COMPLETE DOCUMENTATION.

BIOBURDEN TESTING - MEMBRANE FILTRATION TECHNIQUE
M510 Bioburden Exhaustive Rinse Validation, per unit  
M511 Bioburden Inoculated Product Recovery, per unit  
M512 Bioburden Validation in conjunction with other qualification programs  

FOR PRODUCTS THAT ARE CONSUMED BY THE NATURE OF THE TEST (E.G. LIQUIDS, GELS, POWDERS), PLEASE INCLUDE AT LEAST ONE ADDITIONAL SAMPLE TO BE USED AS A POSITIVE CONTROL ON ALL BIOBURDEN TESTS.

GENERAL MICROBIOLOGY
M600 Biological Indicator – spore strip population assay USP, 3 strips, one species  
M601 Biological Indicator – spore strip population assay USP, 3 strips, dual species  
M602 Biological Spore suspension population assay  
M603A Product Inoculations, Bacillus atrophaeus 106 per site  
M603 Product Inoculations, Geobacillus stearothermophilus 105 per site  
M604 BI Incubation Time Reduction Study (CDRH) FDA Method  
M605 Bacteria Gram Stain, per ID  
M607 Identification of Bacteria (IDS System)  
M607D Identification of Bacteria (DNA Sequencing)  
M608 Identification of fungi  
M609 Identification of yeast  
M610 Total Coliform, presence/absence  
M610A Total Coliform, Standards Methods, Membrane Filtration  
M611 Water Analysis – Heterotrophic Plate Count, per sample  
M700 Bacteriostasis/Fungistasis Testing (USP) – two media, sex organisms  
M701 Bacteriostasis/Fungistasis Testing, one media - SCD AAMI, three organisms  
M702 Bacteriostasis/Fungistasis Testing, per organism  
M703 Growth Promotion Test (USP)  
M704 Growth Promotion Testing per organism  
M705 Microbial Limits Test (USP) including preparatory test  
M706 Microbial Limits Screening/Confirmation  
M708 Contamination (bioburden) of Calcium Alginate Fiber, per sample  
M709 Solubility of Calcium Alginate Fiber, per sample  
M710 Zone of Inhibition – Diffusible Substances (AATCC)  
M711 Antifungal Activity Assessment (AATCC)  
M712 Yeast Analysis – Microbrewery  
M713 Particulate Analysis, Medical Device, USP 788, per sample  
M713A Particulate Analysis, Medical Device, USP 788, multiple small items pooled, per test  
M713B Particulate Analysis, Solutions, USP 788, per sample  
M714 Particulate Analysis, ISO 1135-4, per lot  

USP MONOGRAPHS FOR THE MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS
USP Monograph <61> Microbial Enumeration Test and Monograph <62> Test for Specified Microorganisms (previously known as Microbial Limits testing) are new harmonized chapters that describe new requirements for the growth and recovery of specific organisms which include Psuedomonas aeruginosa, Staphylococcus aureus, Salmonella , Bile-Tolerant Gram negative bacteria, Clostidium, and Candida albicans. Please note that UPS requires that products undergo a one-time validation (suitability test) be conducted before routine testing is conducted.

GENERAL MICROBIOLOGY
M740 System suitability, per organism  
M742 Microbial Enumeration, includes standard plate count for bacteria, yeast and molds, per sample  
M744 Absence of specified Microorganisms, per organism  

USP <51> ANTIMICROBIAL EFFECTIVENESS TEST

GENERAL MICROBIOLOGY
M745 Qualification of Neutralization, plate count method  
M746 1 Replicate, 5 Organisms, 7 Day incubation  
M747 1 Replicate, 5 Organisms, 14 Day incubation  
M748 1 Replicate, 5 Organisms, 7, 14 and 28 Day incubation  
ENVIRONMENTAL MICROBIOLOGY
M750 RODAC Surface Touch Plates, Tryptic Soy w/Lecithin and Polysorbate, each  
M750A RODAC Surface Touch Plates, fungi, Sabouraud Dextrose w/Lecithin and Polysorbate, each  
M750B RODAC Surface Touch Plates, anaerobic, Trypic Soy w/Lecithin and Polysorbate, each  
M751 Settling (fall-out) Plates, Tryptic Soy w/5% Sheep Blood, each  
M751A Settling (fall-out) Plates, Sabouraud Dextrose, each  

ABOVE PRICES INCLUDES SUPPLY OF PLATES, INCUBATION, ANALYSIS, AND REPORTING OF RESULTS

ENVIRONMENTAL MICROBIOLOGY
M752 Impact Viable Air Sampler Plates, aerobic, Tryptic Soy w/Lecithin and Polysorbate, (m3 of air) each  
M752A Impact Viable Air Sampler Plates, fungi, Sabouraud Dextrose w/Lecithin and Polysorbate, (m3 of air) each  
M752B Impact Viable Air Sampler Plates, anaerobic, Tryptic Soy w/Lecithin and Polysorbate, each  
M753 Surface - Swab Test Method, each  
M754 Viable count of Compressed Air System, each point of use  
M759 Clean Room total particulate air counts, per hour  
M755 On-site sample collection, per hour, plus expenses (minimum 2 hrs.)  
M756 Incubation and Analysis of customer supplied environmental plates, each (includes characterization of the (1) most predominant organisms observed)  
M757 Characterizations and gram stain of each additional isolate  
M775 Viable Environmental Program - Monitoring Validation Protocol development  
PACKAGING TESTS
M800 Package Integrity - Accelerated Aging Q10 Coefficient (FDA) Method price is per accelerated year, per carton up to 2.5 cubic foot
above 2.5 cubic foot add $2.50/ft2 per week
 
M801 Package Seal Integrity – Peel Strength, ASTM Method, per seal/pull  
M802 Dye penetration/migration with or without surfactant, per package  
M803 Shelf-Life Stability Sterility Test accelerated aging, 10 samples per time interval  
M804 Shelf-Life Stability Sterility Test, real-time expiration dating  
M805 RODAC Agar Method assessment of porous material  
M806 Vacuum Challenge Method of porous material  
M806A Closure Test Method of porous material  
BIOLOGICAL / TOXICOLOGY
BACTERIAL ENDOTOXIN TESTS
B100 BET, Gel-Clot, Medical Device Extract w/CSE FDA Method  
B100A BET, Gel-Clot, repeat test – Quantitative Dilution Assay to determine product endpoint (5 dilutions)  
B100B BET, Gel-Clot, Medical Device Extract w/RSE USP Reference Method  
B101 BET, Gel-Clot, Inhibition/Enhancement, 4 replicate FDA Method  
B104 BET, Photometric - Turbidimetric Method, 3 replicate FDA Method  
B105 BET, Photometric – Turbidimetric Method, USP Method  
B105A BET, Turbidimetric – repeat test to determine product endpoint/inhibition removal, per dilution  
B106 BET, Photometric – Chromogenic Method, USP  
ETHYLENE OXIDE RESIDUAL TESTS
B200 EO, ECH, EG, (water extraction) Simulated Use ANSI/AAMI/ISO, one sample  
B200A EO, ECH, EG, (water extraction) Simulated Use ANSI/AAMI/ISO, multiple samples, each  
B201 EO, ECH, Exhaustive Extraction, 1st Extraction
Each additional extraction
exhaustive extraction recovery with water until the amount of EO or ECH in a subsequent extraction is <10% of that detected in the first extraction or until there is no analytically significant increase in the cumulative residue recovered
 
B202 EO, Exhaustive Extraction, Thermal Head-Space Analysis, per sample  
B203 ECH (only) water extraction  
B204 EO (only) water extraction  
B205 EG (only) water extraction  
B206 EO, ECH, EG Device  
B207 EO, ECH, EG for liquid samples  
B208 Evaluation of Overlapping/Interfering peaks  
B210 Establishment of Dissipation Curve  
TOXICOLOGY / CHEMISTRY
CYTOTOXICITY TESTS
B300 Direct Contact, Cell Culture Assay, 24 hour incubation, triplicate L929 cells  
B301 Agar Overlay, Cell Culture Assay, 24 hour incubation, triplicate L929 cells  
B302 MEM Elution Method, 48 hour incubation, triplicate L929 cells  
B302A MEM Elution Method, 72 hour incubation, triplicate L929 cells  
B302B MEM Elution with end point titration  
HEMOLYSIS TEST
B400 Hemolysis Test – Direct Contact, ISO, rabbit blood  
B401 Hemolysis Test – Extraction Method, rabbit blood  
B402 Hemolysis Test, ASTM – Direct Contact, rabbit blood  
B403 Hemolysis Test, ASTM – Extraction Method, rabbit blood  
INFRARED ANALYSIS
C100 IR Scan, per scan  
C101 IR Scan Pyrolysis method  
SPECTROPHOTOMETRY
C200 Extractable Dyes  
C201 Calibration Curve, set-up  
IN-VIVO BIOCOMPATIBILITY
Several USP, ISO, or ASTM In-Vivo test methods are available to assess the biocompatibility of candidate medical device materials. Please contact customer service to review applicable test schemes and schedules.

Partnering Labs - All of the tests listed above are conducted by competent qualified scientists. Several other studies including chemical, analytical and toxicological analyses are available through the use of qualified, subcontracted partner labs. Inquire about a particular test method which may not be listed here. Consultations and quotations can be arranged, tailored to your needs.

PRICE ADJUSTMENTS

Terms and Conditions

  1. GLP Documentation - Test requiring full GLP compliance (protocol development, quality assurance reviews, record keeping and archiving) an additional minimum charge of 50% will be applied. GLP studies must be pre-approved by the sponsor and the laboratory and performed according to a specific protocol. Please contact customer service before samples are submitted.
  2. Ethide prides itself with prompt, turnaround service. Test requiring urgent or immediate service will be honored when capabilities permit. However when test requested on a "STAT" basis require workflow/scheduling interruptions, overtime, after-hours, weekend, or holiday services a 50% additional charge may be applied.
  3. Test(s) requiring special sample preparation, handling, manipulations or other conditions may incur additional charges.
  4. The minimum fee for a test and report is $50.00
  5. Reports for final release are usually faxed to the client at no charge. Request for faxed reports for non-release testing or submission of additional reports may be assessed a $5.00 charge.
  6. Multiple sample/ tests discounts may be available in some situations. Please inquire
  7. Terms: Listed prices are discounted prices for payment within 30 days. After thirty days, the "amount due after 30 days" indicated on invoices will then apply.
  8. Prices are subject to change without notice. Price quotations issued upon request are valid for 90 days.

PRICES LISTED OR QUOTED ARE FOR U.S. DOLLARS OR CHECKS DRAWN ON U.S. BANKS.

SAMPLE SUBMISSION

  1. Purchase Orders: In line with current ISO/QSR purchasing requirements, all orders should be sent with a signed completed Purchase Order. This will help expedite the processing or your order. Standing Purchase Orders will be gladly accepted for routine continuing orders.
  2. Sample Submission Form: Please fill out a Test Request Form for each sample/test submitted. Identify each submission clearly and completely. Please be specific with the description, Lot Number, PO etc. and specify the test desired. Please indicate the Test Code Number on the form also. This will greatly reduce turnaround time necessary to generate an accurate, final report.
  3. Final Reports: Listed prices include the submission of a final report to the client by U.S. Mail and maintenance of all records and raw data for five years. Request for overnight delivery, extra copies of reports, return of samples, and archiving of records longer than five years can be honored. Charges for these will be applied accordingly.