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