Our Services

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.

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.

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.

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.

USP <51> ANTIMICROBIAL EFFECTIVENESS TEST

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

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.