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LIST OF SERVICES
MICROBIOLOGY
STERILITY TEST - PRODUCT IMMERSION - DIRECT TRANSFER
| Test Code |
Description |
| 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
| Test Code |
Description |
| M200 |
For volumes up to 100ml product flush – devices, each |
STERILITY TEST - BIOLOGICAL INDICATOR (BI) STERILITY TESTING
| Test Code |
Description |
| 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
| Test Code |
Description |
| M300 |
USP, 20 devices, fluid pathway up to 100ml |
| M301 |
Individual Devices, up to 100ml fluid pathway |
| M302 |
Individual Sample |
STERILITY TEST - DEVICE VERIFICATION DOSE – STERILITY TESTING
ANSI/AAMI/ISO - B1 Method - 100 Product Dose Audit – Product Immersion
| Test Code |
Description |
| 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 – STERILITY TESTING
AAMI - VDmax Method - 10 Product Dose Audit
| Test Code |
Description |
| 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
Bacteriostasis and fungistasis testing 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
| Test Code |
Description |
| M500 |
Aerobic bacteria only |
| M501 |
Aerobic bacteria & fungi |
| M502 |
Aerobic bacteria & spore forming |
| M503 |
Aerobic bacteria & fungi & spores |
| M504An |
Anaerobic bacteria in addition to any test above |
BIOBURDEN TESTING - MEMBRANE FILTRATION TECHNIQUE
| Test Code |
Description |
| M505 |
Aerobic bacteria only |
| M506 |
Aerobic bacteria & fungi |
| M507 |
Aerobic bacteria & spore forming |
| M508 |
Aerobic bacteria & fungi & spores |
| 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.
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| 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
| Test Code |
Description |
| 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 |
| M603 |
Product Inoculations, Bacillus atrophaeus 106 per site |
| M604 |
Product Inoculations, Geobacillus stearothermophilus 105 per site |
| M605 |
BI Incubation Time Reduction Study (CDRH) FDA Method |
| M606 |
Bacteria Gram Stain, per ID |
| M607 |
Identification of Bacteria (IDS System) |
| M608 |
Identification of fungi |
| M609 |
Identification of yeast |
| M610 |
Total Coliform, presence/absence |
| M611 |
Water Analysis – Heterotrophic Plate Count, per sample |
| M700 |
Bacteriostasis/Fungistasis Testing (USP) – two media |
| M701 |
Bacteriostasis/Fungistasis Testing, one media |
| 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 |
ENVIRONMENTAL MICROBIOLOGY
| Test Code |
Description |
| M750 |
RODAC Surface Touch Plates, Tryptic Soy w/Lecithin and Polysorbate, each |
| M750A |
RODAC Surface Touch Plates, Sabouraud Dextrose 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 |
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ABOVE PRICES INCLUDES SUPPLY OF PLATES, INCUBATION, ANALYSIS, AND REPORTING OF RESULTS |
| M752 |
Impact Viable Air Sampler Plates Tryptic Soy w/Lecithin and Polysorbate, (m3 of air) each |
| M752A |
Impact Viable Air Sampler Plates Sabouraud Dextrose w/Lecithin and Polysorbate, (m3 of air) each |
| M753 |
Clean room particulate air counts, per hour |
| M755 |
On-site sample collection, per hour, plus expenses (minimum 2 hrs.) |
| M756 |
Incubation & Analysis (including gram stain) of customer supplied environmental plates, each |
PACKAGING TESTS
| Test Code |
Description |
| 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
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| 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 |
| M806 |
Closure Test Method of porous material |
BIOLOGICAL / TOXICOLOGY TESTING
BACTERIAL ENDOTOXIN TESTS
| Test Code |
Description |
| B100 |
LAL, Gel-Clot, Medical Device Extract w/CSE FDA Method |
| B100A |
LAL, Gel-Clot, repeat test – Quantitative Dilution Assay to determine product endpoint (5 dilutions) |
| B100B |
LAL, Gel-Clot, Medical Device Extract w/RSE USP Reference Method |
| B101 |
LAL, Gel-Clot, Inhibition/Enhancement, 4 replicate FDA Method |
| B105 |
LAL, Photometric – Turbidimetric Method, USP Method |
| B105A |
LAL, Turbidimetric – repeat test to determine product endpoint/inhibition removal, per dilution |
| B106 |
LAL, Photometric – Chromogenic Method, USP |
ETHYLENE OXIDE RESIDUAL TESTS
| Test Code |
Description |
| B200 |
EO, ECH, EG, (water extraction) Simulated Use ANSI/AAMI/ISO 10993-7, per extraction |
| B201 |
EO, ECH, EG, Exhaustive Extraction, 1st extraction |
| B202 |
EO (only) water extraction |
| B203 |
ECH (only) water extraction |
| B204 |
EG (only) water extraction |
| B205 |
EO, ECH, EG for liquid samples |
| B206 |
Evaluation of Overlapping/Interfering peaks |
| B207 |
Establishment of Dissipation Curve |
TOXICOLOGY/CHEMISTRY TESTING
CYTOTOXICITY TESTS
| Test Code |
Description |
| 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
| Test Code |
Description |
| 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
| Test Code |
Description |
| C100 |
IR Scan, per scan |
| C101 |
IR Scan Pyrolysis method |
SPECTROPHOTOMETRY
| Test Code |
Description |
| C200 |
Extractable Dyes |
| C200C |
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.
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