MEDICAL DEVICES
ANALYTICAL CHEMISTRY
⦁ Active ingredients for coating or pharmaceutical product
⦁ USP <232> Elemental Impurities by ICP-MS
⦁ Minerals by ICP-MS
⦁ Moisture
⦁ Water activity
⦁ Active ingredient purity test
⦁ Residual solvents
⦁ Method development
⦁ Combination devices
⦁ Stability storage ICH compliant
MICROBIOLOGY
⦁ USP <55> Biological Indicator – Sterility Testing
⦁ USP <55> Biological Indicator – spore count determination
⦁ USP <62> Microbiological Examination of Nonsterile Products: Suitability Test for Specified Microorganisms
⦁ USP <61> Microbial Examination of Nonsterile Products – Microbial Enumeration Tests
⦁ USP <71> Sterility testing
⦁ USP <85> Bacterial Endotoxin
⦁ Microbial container closure integrity testing
⦁ USP <51> Antimicrobial effectiveness testing
⦁ Irradiation Dose Audit Bioburden Determination (ISO11737-1)
⦁ Irradiation Dose Audit Sterility Testing (ISO11737-2)
⦁ Disinfectant efficacy studies USP <1072>, AOAC, EU
⦁ Custom antimicrobial efficacy studies for liquid and surface coatings
⦁ Custom antimicrobial efficacy studies for UV sanitization devices
⦁ Cleanroom EM and Validations Services
⦁ Critical Utilities Sampling and Validation (Water and Gases)