| TEST NUMBER |
DESCRIPTION |
| |
|
| |
Endotoxin Testing |
| 1003 |
LAL Inhibition/Enhancement (Med. Devices) per 3 lots |
| 1003CA |
LAL Inhibition/Enhancement, Chromogenic (ACC), per 3 lots |
| 1003CC |
LAL Inhibition/Enhancement, Chromogenic (Cambrex), per 3 lots |
| 1003CE |
LAL Inhibition/Enhancement, Chromogenic (Endo), per 3 lots |
| 1003P |
LAL Inhibition/Enhancement, Gel Clot Pharmaceutical, per 3 lots |
| 1003T |
LAL Inhibition/Enhancement, Turbidimetric |
| |
|
| |
|
| 1002CA |
Bacterial Endotoxin, Chromogenic (ACC) |
| 1002CC |
Bacterial Endotoxin, Chromogenic (Cambrex) |
| 1002CE |
Bacterial Endotoxin, Chromogenic (Endo) |
| 1002F |
Bacterial Endotoxin, Gel Clot (FDA), per lot |
| 1002F-Add |
Additional samples received concurrently for Endotoxin testing |
| 1002FP |
Bacterial Endotoxin Testing, FDA Method Pharmaceutical |
| 1002T |
Bacterial Endotoxin, Turbidimetric (ACC) |
| 1002U |
Bacterial Endotoxin Testing, USP Method |
| 1002UP |
Bacterial Endotoxin Testing, USP Method Pharmaceutical, per lot |
| |
|
| |
|
| |
Bioburden Testing |
| 1012A |
Bioburden Recovery Factor, AAMI Spore Inoculation Method (5 Sterile Samples) |
| 1012B |
Bioburden Recovery Factor, AAMI Exhaustive Extraction Method (5 Non-sterile Samples) |
| 1006 |
Total Aerobic Bioburden, Membrane Filtration, per sample |
| 1006/1008 |
Total Aerobic/Anaerobic Bioburden, Membrane Filtration, per sample |
| 1006/1008/1009 |
Total Anaerobic/Aerobic/Fungal Bioburden, Membrane Filtration, per sample |
| 1006/1009 |
Total Aerobic/Fungal Bioburden, Membrane Filtration, per sample |
| 1006A |
Total Aerobic Bioburden, Pour Plate, per sample |
| 1006A/1009A |
Total Aerobic/Fungal Bioburden, Pour Plate, per sample |
| 1006C |
Total Aerobic Bioburden, Membrane Filtration/Pour Plate - Up to 10 Sample Composite |
| 1007 |
Total Sporeformer Bioburden, Membrane Filtration, per sample |
| 1007A |
Total Sporeformer Bioburden, Pour Plate, per sample |
| 1007C |
Total Sporeformer Bioburden, Membrane Filtration/Pour Plate - Up to 10 Sample Composite |
| 1008 |
Total Anaerobic Bioburden, Membrane Filtration, per sample |
| 1008A |
Total Anaerobic Bioburden, Pour Plate, per sample |
| 1008C |
Total Anaerobic Bioburden, Membrane Filtration/Pour Plate - Up to 10 Sample Composite |
| 1009 |
Total Fungal Bioburden, Membrane Filtration, per sample |
| 1009A |
Total Fungal Bioburden, Pour Plate, per sample |
| 1009C |
Total Fungal Bioburden, Membrane Filtration/Pour Plate - Up to 10 Sample Composite |
| 1009P |
Pyronema Domesticum Screen, per sample |
| 1010 |
Total Bioburden, Pour Plate, per sample |
| 1010C |
Total Bioburden, Pour Plate - Up to 10 Sample Composite |
| 1011 |
Total Bioburden, Membrane Filtration, per sample |
| 1011 (1-2) |
Total Bioburden, Membrane Filtration, 1-2 samples |
| 1011A |
USP Spore Strip Population Assay (3 Strips) |
| 1011B |
Liquid Biological Ampoule Population Assay (3 BIs) |
| 1011C |
Total Bioburden, Membrane Filtration - Up to 10 Sample Composite |
| 1011D |
Spore Strip Population, ISO 11138 |
| 1011E |
Population Assay of Spordex Biological Indicator (Spore Strips), 10 spore strips tested individually |
| |
|
| |
|
| |
Microorganism Identification |
| 1161 |
Microbial Identification using Micro-Seq System, includes gram stain rxn, 1-5 isolates received and tested concurrently, price per isolate |
| 1162 |
Microbial Identification using Micro-Seq System, includes gram stain, 6-10 isolates received and tested concurrently, price per sample |
| 1163 |
Yeast and Mold Identification using Micro-Seq System, includes gram stain,1-5 isolates received and tested concurrently, price per isolate |
| 1164 |
Yeast and Mold Identification using Micro-Seq System, includes gram stain, 6-10 isolates received and tested concurrently, price per isolate |
| 1014 |
Salmonella Identification (A-G or A-S) |
| 1016 |
S.aureus, slide agglutination test, identification confirmation.. |
| 1017 |
Gram Stain of Isolates, per isolate |
| 1017S |
Spore Stain of Isolates, per isolate |
| |
|
| |
|
| |
Disinfectant Testing |
| 1019 |
AOAC Use Dilution Test, 3 Organisms, 60 Carriers per Organism |
| 1019-10 |
AOAC Use Dilution Test, 10 Carriers per Organism |
| 1019-add |
AOAC Disinfectant Testing, 10 Carrier Methods, Additional Organism |
| 1019A |
AOAC Use Dilution Testing, Additional Organisms, 60 Carriers, per organism |
| 1019C |
AOAC Germicidal Spray Test, 3 organisms, 10 coupons per organism |
| 1019F |
AOAC Fungicidal Activity of Disinfectants Testing |
| 1019M |
Modified AOAC Use Dilution Test, One Organism, 60 Carriers |
| 1019S |
AOAC Sporicidal Activity of Disinfectants Testing, 2 Organisms, 60 Carriers per Organism, Porcelain or Stainless Steel Carriers, per carrier type |
| 1019S-add |
AOAC Sporicidal Activity of Disinfectants Testing, 60 Carriers per Organism, Porcelain or Stainless Steel, Additional Organisms, per organism |
| 1019T |
AOAC Tuberculocidal Activity of Disinfectants Testing, 2 organisms, 20 Carriers per Organism |
| |
|
| |
|
| |
Filter Integrity Testing |
| 1022A |
Filter Integrity Testing (using B.dimunuta), 1-10 Filters |
| 1022B |
Filter Integrity Testing (using S.marcesens), 1-10 Filters |
| 1022C |
Filter Integrity Testing, 1-10 Filters |
| 1022D |
Bubble Point Testing |
| 1022E |
Filter Integrity Testing - Viral, 1-10 Filters |
| 1022F |
Filter Integrity Testing - Viral, 1-10 Filters |
| 1022G |
Filter Integrity Testing - Viral, 1-10 Filters |
| |
|
| |
|
| |
Particulate Testing (products) |
| 1023A |
Particulate Testing, Medical Devices - Microscopic Analysis |
| 1023B |
USP <788> Particulate Testing, Light Obscuration (LP) Method, per sample |
| |
|
| |
|
| |
Bacteriostasis/Fungistasis Test |
| 1005 |
USP Bacteriostasis/Fungistasis Testing, 5 organisms - 6 samples |
| 1005A |
USP Growth Promotion Testing (1-10 Samples) |
| 1005A-Add |
USP Growth Promotion Testing, Additional Samples Received and Tested Concurrently, per sample |
| 1005AA |
Bacteriostasis/Fungistasis Testing, AAMI, 4 organisms - 4 samples, TSB Only |
| 1005AP |
Bacteriostasis/Fungistasis Testing, SteriTest |
| 1005EP |
EP Bacteriostasis and Fungistasis |
| 1005MF |
USP Bacteriostasis/Fungistasis Testing, Membrane Filtration (6 samples) |
| |
|
| |
|
| |
AAMI/ISO Sterility Tests |
| |
Product Immersion Method |
| 1026 DOSE SETTING |
Set Verification Sterilization Dose |
| 1026A (40) |
AAMI Verification Dose Sterility
Testing (40 samples) TSB only, (VD Max), Bolus Unit (CSF-214) |
| 1026G |
AAMI Verification Dose Sterility Test (100 Samples) |
| 1026GA (10) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 10 samples |
| 1026GA (10)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GA (100) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 100 samples |
| 1026GA (100)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GA (20) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 20 samples |
| 1026GA (20)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GA (30) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 30 samples |
| 1026GA (40) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 40 samples |
| 1026GA (40)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GB (10) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 10 samples |
| 1026GB (10)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GB (100) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 100 samples |
| 1026GB (100)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GB (2) |
ANSI/AMMI/ISO Sterility Testing, Product Immersion, 2 samples |
| 1026GB (20) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 20 samples |
| 1026GB (20)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GB (40) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 40 samples |
| 1026GB (40)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GB (50) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 50 samples |
| 1026GB (60) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 60 samples |
| 1026GC (10) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 10 samples |
| 1026GC (10)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GC (100) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 100 samples |
| 1026GC (100)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GC (20) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 20 samples |
| 1026GC (20)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GC (40) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 40 samples |
| 1026GC (40)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GD (10) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 10 samples |
| 1026GD (10)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GD (100) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 100 samples |
| 1026GD (100)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GD (20) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 20 samples |
| 1026GD (20)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GD (40) |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 40 samples |
| 1026GD (40)-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| 1026GJJ |
VD Max Sterilization Method |
| 1026GS |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, 1-3 samples |
| 1026GS-Add |
ANSI/AAMI/ISO Sterility Testing, Product Immersion, each additional sample |
| |
|
| |
|
| |
USP <71> Sterility Testing |
| |
Product Immersion Method |
| 1027 |
USP<71> Sterility Testing, single sample |
| 1027A (10) |
USP<71> Sterility Testing, 1-10 samples |
| 1027A (10)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027A (20) |
USP<71> Sterility Testing, 20 samples |
| 1027A (20)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027A (30) |
USP<71> Sterility Testing, 30 samples |
| 1027A (40) |
USP<71> Sterility Testing, 40 samples |
| 1027A (40)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027B |
USP Product Immersion Sterility, per sample |
| 1027B (10) |
USP<71> Sterility Testing, 1-10 samples |
| 1027B (10)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027B (20) |
USP<71> Sterility Testing, 20 samples |
| 1027B (20)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027B (40) |
USP<71> Sterility Testing, 40 samples |
| 1027B (40)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027C (10) |
USP<71> Sterility Testing, 10 samples |
| 1027C (10)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027C (20) |
USP<71> Sterility Testing, 20 samples |
| 1027C (20)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027C (40) |
USP<71> Sterility Testing, 40 sample |
| 1027C (40)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027D (10) |
USP<71> Sterility Testing, 10 samples |
| 1027D (10)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027D (20) |
USP<71> Sterility Testing, 20 samples |
| 1027D (20)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027D (40) |
USP<71> Sterility Testing, 40 samples |
| 1027D (40)-Add |
USP<71> Sterility Testing, each additional sample |
| 1027S |
USP<71> Sterility Testing, 1-3 samples |
| |
|
| |
|
| |
Biological Indicator Sterility Testing |
| 1028 |
Biological Indicator Sterility Testing, per strip |
| |
|
| |
|
| |
USP <71> Sterility Testing |
| |
Product Flush Method |
| 1029A (10) |
USP<71> Sterility Testing, Product Flush, <200mL, 10 samples |
| 1029A (100) |
USP<71> Sterility Testing, Product Flush, <200mL, 100 samples |
| 1029A (150) |
USP<71> Sterility Testing, Product Flush, <200mL, 101-150 samples |
| 1029A (20) |
USP<71> Sterility Testing, Product Flush, <200mL, 20 samples |
| 1029A (200) |
USP<71> Sterility Testing, Product Flush, <200mL, 151-200 samples |
| 1029A (250) |
USP <71> Sterility Testing, Product Flush, <200mL, 201-250 samples |
| 1029A (30) |
USP<71> Sterility Testing, Product Flush, <200mL, 30 samples |
| 1029A (300) |
USP <71> Sterility Testing, Product Flush, < 200mL, samples 251-300 |
| 1029A (350) |
USP <71> Sterility Testing, Product Flush, <200 mL, samples 301-350 |
| 1029A (40) |
USP<71> Sterility Testing, Product Flush, <200mL, 40 samples |
| 1029B (10) |
USP<71> Sterility Testing, Product Flush, 201-500mL, 10 samples |
| 1029B (100) |
USP<71> Sterility Testing, Product Flush, 201-500mL, 100 samples |
| 1029B (20) |
USP<71> Sterility Testing, Product Flush, 201-500mL, 20 samples |
| 1029B (40) |
USP<71> Sterility Testing, Product Flush, 201-500mL, 40 samples |
| 1029C (10) |
USP<71> Sterility Testing, Product Flush, >500mL, 10 samples |
| 1029C (100) |
USP<71> Sterility Testing, Product Flush, >500mL, 100 samples |
| 1029C (20) |
USP<71> Sterility Testing, Product Flush, >500mL, 20 samples |
| 1029C (40) |
USP<71> Sterility Testing, Product Flush, >500mL, 40 samples |
| 1030 (10) |
Pyronema sterility test, 1-10 samples |
| 1030 (100) |
Pyronema Sterility Testing, (100) samples |
| |
|
| |
|
| |
CFR Sterility Testing |
| 1031 |
CFR Sterility 610.12 Direct Incubation |
| 1031A |
CFR Sterility Testing, 610.12 Membrane Filtration |
| |
|
| |
USP <71> Sterility Testing |
| |
Membrane Filtration Method |
| 1032A |
USP<71> Sterility Testing, Membrane Filtration, single sample |
| 1032A-add |
USP<71> Sterility Testing, Individual Membrane Filtration, each additional sample |
| 1032A (10) |
USP<71> Sterility Testing, Membrane Filtration, 2-10 piece composite |
| 1032A (20) |
USP<71> Sterility Testing, Membrane Filtration,11-20 piece composite |
| 1032A (40) |
USP<71> Sterility Testing, Membrane Filtration, 40 piece composite |
| 1032AP |
USP Sterility, SteriSolutest (up to 20 sample composite) |
| |
|
| |
|
| |
Reusable Device Validations |
| 1033C |
Reusable Device Sterilization Validation - Liquid Chemical (1 Device Type in Triplicate - 3 Cycles) |
| 1033E |
Reusable Device Sterilization Validation - ETO (1 Device Type in Triplicate - 3 Cycles) |
| 1033S |
Reusable Device Sterilization Validation - Steam (1 Device Type in Triplicate - 3 Cycles) |
| 1034 |
Cleaning Study (MicroTest Cleaning - 1 Device Type in Triplicate - 3 Cycles) |
| 1034C |
Reusable Device Cleaning Qualification - Client Cleaning (1 Device Type in Triplicate - 3 Cycles) |
| 1034H |
High Level Disinfection Validation (1 Device Type in
Triplicate - 3 Cycles) |
| 1034L |
Low Level Disinfection Validation (1 Device Type in
Triplicate - 3 Cycles) |
| 1034M |
Reusable Device Cleaning Qualification (MTL Cleaning) |
| 1034P |
Protein Reduction Challenge |
| |
|
| |
|
| |
Accelerated Aging Studies |
| 1036 |
Accelerated Aging, Medical Devices |
| 1036 0.5 |
Accelerated Aging, Medical Devices, 6 Month Simulated, up to 10 cubic feet |
| 1036 1.0 |
Accelerated Aging, Medical Devices, 1 Year Simulated, up to 10 cubic feet |
| 1036 1.5 |
Accelerated Aging, Medical Devices, 1.5 Year Simulated, up to 10 cubic feet |
| 1036 2.0 |
Accelerated Aging, Medical Devices, 2 Year Simulated, up to 10 cubic feet |
| 1036 2.5 |
Accelerated Aging, Medical Devices, 2.5 Year Simulated, up to 10 cubic feet |
| 1036 3.0 |
Accelerated Aging, Medical Devices, 3 Year Simulated, up to 10 cubic feet |
| 1036 3.5 |
Accelerated Aging, Medical Devices, 3.5 Year Simulated, up to 10 cubic feet |
| 1036 4.0 |
Accelerated Aging, Medical Devices, 4.0 Year Simulated, up to 10 cubic feet |
| 1036 4.5 |
Accelerated Aging, Medical Devices, 4.5 Year Simulated, up to 10 cubic feet |
| 1036 5.0 |
Accelerated Aging, Medical Devices, 5.0 Year Simulated, up to 10 cubic feet |
| |
|
| |
|
| |
Packaging Integrity Testing |
| 1037A |
Microbial Aerosol Challenge, Up to 10 Samples |
| 1037B |
Microbial Vial Integrity Challenge using E.coli (up to 100 Vials) |
| 1037C |
Microbial Vial Integrity Challenge using Brevundimonas dimunuta (up to 100 Vials) |
| 1038 |
ASTM F88 Peel Strength Testing (1-10 Samples, 3 Sides) |
| 1038-Add |
ASTM F88 Peel Strength Testing, each additional sample |
| 1039B |
ASTM F1140 Package Burst Testing (1-10 Samples; 5 extra
samples required for set up) |
| 1039B-Add |
ASTM F1140 Package Burst Testing, each additional sample |
| 1039D |
Methylene Blue Dye Package Challenge (Minimum Sample
Requirement = 10), per sample |
| 1039F |
ASTM F1140 Creep to Failure Test (Minimum Sample
Requirement = 10), 10 Samples |
| 1039G |
ASTM F1140 Leak Test (Minimum Sample Requirement = 10), 10
Samples |
| 1039G-Add |
ASTM F1140 Leak Test, each additional sample |
| 1039H |
Vial Integrity Challenge - Methylene Blue Dye, up to 50
Vials per Lot |
| 1039I |
Vial Integrity Challenge - Methylene Blue Dye (combined vacuum/pressure method), up to 50 Vials per Lot |
| 1039P |
Bubble Leak Test |
| 1039S - 1A |
ISTA Ship Testing, Project 1A, per carton |
| 1039S - 2A* |
ISTA Ship Testing, Project 2A, per carton |
| |
|
| |
|
| |
Purified/WFI Water System Testing |
| |
Microbiological Methods |
| 1090M |
Fecal Coliform Count, Membrane Filtration, first sample |
| 1090M-Add |
Fecal Coliform Count, Membrane Filtration, additional samples received and tested concurrently |
| 1090P |
Fecal Coliform Count, Pour Plate, per sample |
| 1091M |
Total Coliform Count, Membrane Filtration, first sample |
| 1091M-Add |
Total Coliform Count, Membrane Filtration, additional samples received and tested concurrently |
| 1091P |
Total Coliform Count, Pour Plate, per sample |
| 1092M |
Heterotrophic Plate Count, Membrane Filtration, first sample |
| 1092M-Add |
Heterotrophic Plate Count, Membrane Filtration, additional samples received and tested concurrently |
| 1092M/1091M |
Heterophic Plate Count/Coliform Screen |
| 1092M/1091M-Add |
Heterophic Plate Count/Coliform Screen, each additional sample received and tested concurrently |
| 1092P |
Heterotrophic Plate Count, Pour Plate, per sample |
| 1092P-Add |
Heterotrophic Plate Count, Pour Plate, each additional sample, price per sample |
| 1093M |
Total Fungal Count, Membrane Filtration, first sample |
| 1093M-Add |
Total Fungal Count, Membrane Filtration, additional samples received and tested concurrently |
| 1093P |
Total Fungal Count, Pour Plate, per sample |
| 1096M |
Fecal Streptococcus Count, Membrane Filtration, first sample |
| 1096M-Add |
Fecal Streptococcus Count, Membrane Filtration, additional samples received and tested concurrently |
| 1096P |
Fecal Streptococcus Count, Pour Plate, per sample |
| |
|
| |
|
| |
Purified/WFI Water System Testing |
| |
Analytical Chemistry Methods |
| 4008 |
USP Purified Water Testing, (includes TOC/Conductivity),
1-5 samples, per sample |
| 4008-Add |
USP Purified Water Testing, (includes TOC/Conductivity),
6-10 samples, per sample |
| 4008-Add2 |
USP Purified Water Testing, (includes TOC/Conductivity),
11-15 samples, per sample |
| 4008-Add3 |
USP Purified Water Testing, (includes TOC/Conductivity), 16
or more samples, per sample |
| 4008T |
USP TOC, 1-5 samples, per sample |
| 4008T-add |
USP TOC, 6-10 samples, per sample |
| 4008T-Add2 |
USP TOC, 11-15 samples, per sample |
| 4008T-Add3 |
USP TOC, 16 or more samples, per sample |
| 4013 |
Gravimetric Analysis of Leachates |
| 4060 |
USP Purified Rayon - Acid Insoluble Ash |
| 4061 |
USP Purified Rayon - Water Soluble Substances |
| 4062 |
USP Purified Rayon - Residue on Ignition |
| 4001 |
USP Heavy Metals as Lead Testing |
| 4002 |
USP Buffering Capacity |
| 4003 |
USP Non-volatile Residues Testing |
| 4003A |
USP Non-volatile Residues Testing (ETOH Extraction) |
| 4004 |
USP Residues on Ignition Testing |
| 4004A |
USP Residues on Ignition Testing (ETOH Extraction) |
| 4004R |
Water Soluble Substances, per sample: |
| 4005 |
USP <661> Physicochemical Testing (Complete MTL
4001-4004) |
| 4007 |
pH Testing |
| 4007U |
UV Vis Spectroscopy, per sample |
| |
|
| |
|
| |
ETO Residual Testing |
| |
Analytical Chemistry |
| 1154 |
ETO/ECH Residual Testing,
Simulated Use, samples set-up fee and first sample, per sample |
| 1154-Add |
ETO/ECH Residual Testing, Simulated Use,..samples 2-10, price per sample |
| 1154-Add2 |
ETO/ECH Residual Testing, Simulated Use, samples 11+, price per sample |
| 1155 |
ETO/ECH Residual Testing,
Exhaustive Recovery, set-up and first sample, price per sample |
| 1155-Add |
ETO/ECH Residual Testing, Exhaustive Recovery, samples 2-10, price per sample |
| 1155-Add2 |
ETO/ECH Residual Testing, Exhaustive Recovery...Samples 11+, price per sample |
| |
|
| |
|
| |
Biocompatibility Testing |
| 2001* |
Pyrogen Test, (USP <151>), 3 Rabbits; failures are subject to an additional fee |
| 2001EP* |
EP Rabbit Pyrogen Testing, failures are subject to additional fee, per sample |
| 2001EPQ* |
EP Rabbit Pyrogen Test, 3 Rabbits with Quarantine (in the event of failure) |
| 2001Q* |
Pyrogen Test, (USP <151>), 3 Rabbits with Quarantine (in the event of failure) |
| 2002* |
Pyrogen Test, (USP <151>), 5 Rabbit Retest (8 rabbits total); failures are subject to an additional fee |
| 2002Q* |
Pyrogen Test, (USP <151>), 5 Rabbit Retest with Quarantine (in the event of failure; 8 rabbits total).. |
| 2003* |
General Safety Test (USP <88>) |
| 2003B* |
Biologics Safety Test, (USP <88>) |
| 2004* |
Systemic Injection Testing, (USP <88>), per extract |
| 2004A* |
14 Day Subchronic Toxicity Testing, (Mouse Model, Includes Necropsy) |
| 2004B* |
30 Day Subchronic Toxicity Testing, (Mouse Model, Includes Necropsy) |
| 2004C* |
90 Day Subchronic Toxicity Testing, (Mouse Model, Includes Necropsy) |
| 2004D* |
120 Day Chronic Toxicity Testing, (Mouse Model, Includes Necropsy) |
| 2004E* |
180 Day Chronic Toxicity Testing, (Mouse Model, Includes Necropsy) |
| 2004I* |
Systemic Injection Testing, (ISO), 2 extracts |
| 2005* |
Intracutaneous Reactivity, (USP <88>, per extract |
| 2005I* |
ISO Intracutaneous Reactivity Testing, 2 extracts |
| 2006* |
ISO Muscle Implant, 2 Rabbits, 7 Days, Includes Histopathology |
| 2006A* |
ISO Surgical Muscle Implant Test, 2 Rabbits, 14 Days, Includes Histopathology |
| 2006B* |
ISO Surgical Muscle Implant Test, 3 Rabbits, 90 Days, Includes Histopathology |
| 2006C* |
ISO Surgical Muscle Implant Test,3 Rabbits, 180 Days, Includes Histopathology |
| 2006I |
ISO Muscle Implantation |
| 2009* |
Primary Skin Irritation Testing, 6 Rabbits, Modified ASTM F719 |
| 2009I* |
Primary Skin Irritation Testing, ISO Method |
| 2010* |
Skin Sensitization Testing, ASTM F720 - Modified Kligman, 1 extract |
| 2010I* |
Skin Sensitization Testing, ISO Method, 2 extracts |
| 2011* |
Class I Plastics Testing, (USP <88>) |
| 2012* |
Class II Plastics Testing, (USP <88>) |
| 2013* |
Class III Plastics Testing, (USP <88>) |
| 2015* |
Class IV Plastics Testing, with 11 Day Implant, (USP <88>) |
| 2016* |
Class V Plastics Testing, (USP <88>) |
| 2017* |
Class VI Plastics Testing, with 11.. Day Implant, (USP <88>) |
| 2019IL |
ISO Cytotoxicity Testing, L929 Cells, Direct Contact |
| 2019L |
USP Cytotoxicity Testing,L929 Cells, Direct Contact |
| 2020IL |
ISO Cytotoxicity Testing, L929 Cells, Agar Overlay |
| 2020L |
USP Cytotoxicity Testing, L929 Cells, Agar Overlay |
| 2021IL |
ISO Cytotoxicity Testing, L929 Cells, MEM Elution |
| 2021L |
USP Cytotoxicity Testing, L929 Cells, MEM Elution |
| 2022IL |
ISO Cytotoxicity Testing with Endpoint Titration, L929 Cells |
| 2022L |
USP Cytotoxicity Testing with Endpoint Titration, L929 Cells |
| 2024 |
Complement Activation Assay (C3a) |
| 2025R |
Rabbit Blood Hemolysis Testing, Direct Contact |
| 2026R |
Rabbit Hemolysis Testing, extract |
| 2027P |
Prothrombin Time Test |
| 2027PT |
Partial Thromboplastin Time Test |
| 2028 |
Ames Mutagenicity Testing (in Duplicate) |
| 2028A |
ISO Ames Mutagenicity Testing (in Triplicate) |
| 2029* |
Primary Ocular Irritation Testing, 2 Extracts, 72 Hours |
| 2030* |
Vaginal Mucosal Irritation |
| 2031C* |
Sister Chromatid Exchange Analysis (Assay to Detect Primary DNA Damage) |
| 2032M* |
Mouse Lymphoma TK +/- Assay (Assay to Detect Gene
Mutations) |
| 2033M* |
CHO/HGPRT Carcinogenicity (Assay to Detect Gene Mutations) |
| 2035C* |
Mouse Micronucleus Assay (in-vivo), Automated Scoring by Flow Cytometry (Assay to Detect Primary DNA Damage) |
| 2036* |
Acute Oral Toxicity, 20 Rats, OECD Method, without Necropsy, 5000 mg/kg animal body weight required, per sample |
| 2036N* |
Acute Oral Toxicity, 20 Rats, OECD Method, including Necropsy, 5000 mg/kg animal body weight required, per sample |
| 2037 |
MIC Testing, BAM/USP <81>, per organism, per antibiotic type |
| |
|
| |
|
| |
Fungal Resistance of Materials |
| 5005* |
ASTM G-21 Fungal Resistance Testing |
| 5006* |
ASTM D3273 Standard Test Method for Resistance to Growth of Mold on the Surface of Interior Coatings in an Environmental Chamber |
| |
|
| |
|
| |
Resistance of Materials (phage) |
| 8001 |
Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood, ASTM F1670, in Triplicate |
| 8002 |
Resistance of Materials Used in Protective Clothing to Penetration by Blood-borne Pathogens using Phi-X174, ASTM F1671, in Triplicate |
| 8003 |
Glove Leak Test, 21 CFR 800.20 (80 Gloves) |
| |
|
| |
|
| |
Environmental Monitoring |
| 6001A |
Aerobic Air Sampling, per site |
| 6001A/6012A |
Aerobic/Fungal Air Sampling, incubation and analysis only, per sample |
| 6001R |
Aerobic Environmental Plate Analysis Only, per plate |
| 6001S |
Aerobic Surface Sampling, per site |
| 6001S/6012S |
Aerobic/Fungal Surface Sampling, incubation and analysis only, per sample |
| 6002A |
Anaerobic Air Sampling, per site |
| 6002R |
Anaerobic Environmental Plate Analysis Only, per plate |
| 6002S |
Anaerobic Surface Sampling, per site |
| 6012A |
Fungal Air Sampling, per site |
| 6012R |
Fungal Environmental Plate Analysis Only, per plate |
| 6012S |
Fungal Surface Sampling, per site |
| 6020B |
|
| 6030 |
Env. Fungal Culture, 25C, Count and Genus ID |
| 6031 |
Fungal Spore Tape ID and Mycelia Count |
| 6032 |
Fungal Spore Count - Cassette |
| 6040 |
Technician Travel |
| 6040F |
Fume Hood Validation, per hood |
| 6040H |
Hood Certification, Includes:
Velocity Profile, 1 Non-viable Particulate Air Sample, and Smoke Study,
per hood |
| 6040L |
HEPA Filter Validation Testing, per filter |
| 6040P |
Non-viable Particulate Testing, per site |
| 6040PC |
Personnel Cost |
| 6040R |
HEPA Filter Repair, price per filter repaired |
| 6040V |
Velocity Testing, per filter |
| 6041 |
Non-viable Particulate Testing on Compressed Air/Gas, per site |
| 6042 |
Microbial Air Sampling for Compressed Air/Gas, per sample |
| 6043 |
Drager Tube Testing on Compressed Air/Gas, per sample |
| 6044 |
Compressed Air, Dew Point Testing, samples 1-10, price per sample |
| 6044-add1 |
Compressed Air, Dew Point Testing, samples 11-20, price per sample |
| 6044-add2 |
Compressed Air, Dew Point Testing, samples 21-30, price per sample |
| 6047 |
Pressure Differential Characterization |
| 6050 |
Environmental Plate Preparation |
| 6051 |
Draeger Tube testing for Xylene/Formaldehyde |
| |
|
| |
|
| |
Sterilization Cycles |
| 9001 |
ETO Sterilization Cycle, No BI Seeding |
| 9001B |
ETO Sterilization Cycle with BI Seeding |
| 9002 |
Steam Sterilization Cycle, No BI Seeding |
| 9002B |
Steam Sterilization Cycle, with BI Seeding |
