Sterility (USP <71>) - At ARL, we offer both the Membrane Filtration and Direct Inoculation Test methods for sterility testing.  Each product sterility tested must be validated to show that its inherent properties will not inhibit the growth of potential contaminants.
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Endotoxin (USP <85>) - At ARL, we offer both the traditional Gel Clot Method and the advanced technology with the Kinetic Turbidimetric Assay (KTA).  Gel Clot provides sensitivity down to 0.03 EU/mL and the KTA provides sensitivity down to 0.005 EU/mL.  If desired, we can provide results within 24 hours on most products, even if we haven’t tested them before.
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Fungal - At ARL, we also offer a separate fungal test. Years ago we recognized the need that facilities had in which they wanted the extra assurance and extra quality when testing their products.  It has been long discussed in the microbiology world and Pharmacopoeia Forum that the sterility test does have limitations with regards to capturing fungal contamination.
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Bacterial ID - To complement the services offered, we can also provide Bacterial or Fungal identification.  Most bacteria can be identified to the species level (i.e. Genus: Staphylococcus species: aureus).

Validation Test (Bacteriostasis/Fungistasis) - Many people believe that just by inoculating TSB or FTG with your drug that it will detect contamination.  This is not always true and that is why Bacteriostasis/Fungistasis (B/F) testing is done.  The B/F terminology is no longer used in USP 71, but you can find it under the Validation Test section which describes how to ensure your sterility test works for your product.
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Microbial Limits Testing (USP <61> - Microbial limits testing (MLT) is performed on pharmaceutical products and medical devices as a quality control measure. Products or components used in the pharmaceutical or medical field require adequate control of microbial levels during processing and handling as well as ensuring that objectionable organisms like E. coli, Salmonella, Candida, Staphylococcus, and Pseudomonas are not present.
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Environmental Testing - With environmental testing, generally you want to know what’s there so you can have an effective cleaning program.  Let us help.
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Antimicrobial Effectiveness Testing (USP <51>) - The antimicrobial effectiveness test  is a valuable tool for evaluating either intrinsic antimicrobial properties, or the different types of antimicrobial agents added to prevent growth of bacteria.
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