Getsen offers a complete Microbiology and Chemistry Laboratory Testing service including Product Sterility Testing, Pyrogen Testing, Compound/Element Analysis, and Biocompatibility Tests. Water testing, Drug Screening and unknown ID is also part of our capability.

     Key Benefits

• World Leader in qualified laboratory testing services including testing by Nationally Registered Microbiologists in accordance with QSR/ISO9000/GLPs
• Fast responses on Lab Test Results and Reports 
• Competitive Pricing with Reliable Results

     Capabilities

Getsen Laboratories performs test methods including:

     Microbiological and Biocompatibility Testing

Test	Getsen Code	Fee Per Sample ($)
Organism Identification
Organism Characterization: Gram Reaction & Colony Morphology	M0001A	50
Mold Identification	M0002A	75
Yeast	M0003A	75
Test Sterilization/Sterilant Exposure
EO Sterilization of Test Sample	M0005A	385
Steam Sterilization of Test Samples	M0006A	145
Liquid Chemical Exposure	M0007A	105
Bioburden Tests
Total Aerobes	M0008A	65
Total Aerobes plus Spores	M0009A	70
Total Aerobes plus Anaerobes	M0010A	90
Total Aerobes plus Fungi	M0011A	80
Total Aerobes, plus Fungi and Anaerobes	M0012A	95
Total Aerobes, plus Spores and Fungi	M0013A	85
Total Aerobes plus Spores, Anaerobes, and Fungi	M0014A	110
Total Coliforms	M0015A	65
Microbial Limits, USP Preparatory Testing	M0016A	415
Microbial Limits, USP Screening	M0017A	80
Microbial Limits, USP Confirmation	M0018A	100
Biological Indicator Performance Tests
Steam or Ethylene Oxide Exposure	M0019A	265
USP Survival / Kill Test	M0020A	660
USP Survival Only Test	M0021A	405
USP Kill Only Test	M0022A	405
D-Value Studies, 4 exposures	M0023A	1,080
D-Value Studies, and additional Cycles	M0024A	360
Validation of Biological Indicator Incubation Time	M0025A	1,970
BI Population Verification Tests
Heat Shocked Counts	M0026A	195
Heat Shocked and Non-Heat Shocked Counts	M0027A	230
Dual Species BI's, Heat Shocked and Non-Heat Shocked Counts	M0028A	310
Dual Species BI's, Heat Shocked Counts	M0029A	235
Verification of Species, Minimum fee per Isolate	M0030A	100
Product Inoculation
(Minimum of $145 fee per order)
Bacillus subtillis var. nigar (EO or Dry Heat)	M00031A	4
Bacillus stearothermophilus (steam)	M0032A	6
Bacillus pumilus (Radiation)	M0033A	4
Spore Recovery	M0034A	70
AAMI/ISO Gamma/E-Beam Radiation Validation
Bioburden Percent Recovery Method	M0035A	340
Dose Setting Calculation	M0036A	110
Aseptic Preparation of Dose Verification Samples	M0037A	60/hour
Bacteriostasis/Fungistasis, AAMI Method
By Direct Transfer Using Two Organisms	M0038A	140
AAMI Sterility Tests for Radiation Sterilization Method	M0039A	375
USP Sterility Tests
Bacteriostasis/Fungistasis, USP Method
By Direct Transfer Using Three Organisms	M0040A	220
Forty Products, Direct Transfer Method	M0041A	160
Ten Inoculated Products	M0042A	85
Membrane Filtration	M0043A	Inquire
Ten spore Strips, Direct Transfer Method	M0044A	70
Ten, Spore Strips, Within Product	M0035A	75
Additional Sterility Samples, Per Sample	M0036A	3
Extra Gram Stains	M0037A	9
Antimicrobial Tests
Antibacterial Activity Assessment, Parallel Streak	M0038A	90
Assessment of Antimicrobial Finishes	M0039A	215
Antimicrobial Preservatives - Effectiveness	M0040A	145
Bound Antimicrobial Surface Activity	M0041A	Inquire
Dow Corning* Shake Flask	M0042A	85
Kirby-Bauer* Standard Antimicrobial Susceptibility	M0043A	95
Resistance of Plastic to Bacteria	M0044A	170
Resistance of Synthetic Polymeric Materials to Fungi	M0045A	320
Mildew and Rot Resistance of Textile Material	M0046A	90
Sterile Package Integrity Tests
Closure Method	M0047A	440
Dust Drum Method	M0048A	540
Rodac* Method	M0049A	440
Container/Closure Integrity Method	M0050A	Inquire
Shelf Life Studies	M0051A	Inquire
Filter Effectiveness Study	M0052A	Inquire
In Vitro Biocompatibility Tests
Bacterial Endotoxin Tests
Limulus Amebocyte Lysate (LAL) Test, USP         Gel Clot Method
Medical /Device Validation Program for LAL, Per Lot	B0001A	335
Extract of Device - Test Positive, Negative, and Inhibition Controls	B0002A	85
Liquid (as submitted)	B0003A	75
Concurrent Assay of Sample Dilution, per Dilution	B0004A	27
Kinetic-Chromogenic Assay Method, USP
Medical Device Validation Program for LAL, Per Lot	B0005A	335
Extract of Device-Test Positive, Negative, and Inhibition Controls	B0006A	85
Liquid (as submitted)	B0007A	95
Concurrent Assay of Sample Dilution, per Dilution	B0008A	75
Concurrent Assay of Sample Dilution, per Dilution	B0009A	27
Cytotoxicity (Cell Culture)
Agar/Agarose Analysis
Agarose Overlay Screen	B0010A	90
ISO Agarose Overlay	B0011A	165
USP Agar Diffusion	B0012A	155
Elution Analysis
Elution Screen	B0013A	90
ISO Elution	B0014A	165
USP Elution	B0015A	155
Inhibition of Cell growth	B0016A	375
Mutagenicity Assays
Ames Test, Extract	B0017A	1040
Ames Test, Soluble Chemical	B0018A	1040
Ames Test, Liquid	B0019A	1040
Ames Test, Confirmation with Preincubation	B0020A	305
Chromosomal Aberration	B0021A	6150
Sister Chromatid Exchange	B0022A	4850
Color Image of Cells/Tissues for Various Tests	B0023A	12
Other	See Sales Associate Call 361-3GETSEN

 

Chemical Analysis

 

Test	Getsen Code	Fee Per Sample ($)
ASTM & CFR Tests
ASTM Condom Tests, Minimum 125 Samples	C0001A	Inquire
Extractables - Rubber Articles Intended for Repeated Use	C0002A	195
Rubber Glove Leak Test - ASTM, minimum 80 samples	C0003A	4
Ethylene Oxide (EO) Residues
EO Analysis, Headspace	C0004A	115
EO Analysis, Water Extraction	C0005A	110
ECH and EG Analysis, Water Extraction	C0006A	160
ECH Analysis, Water Extraction	C0007A	110
EG Analysis, Water Extraction	C0008A	110
General chemistry Tests
Infrared (FTIR) Analysis	C0009A	95
Gas Chromatography	C0010A	Inquire
Freon	C0011A	245
Glutaraldehyde	C0012A	245
IPA	C0013A	245
Methanol
Melting Point Determination	C0014A	65
Moisture Determination by Oven Drying	C0015A	65
Moisture Determination - Karl Fisher	C0016A	75
Optical Rotation	C0017A	70
Osmolarity	C0018A	80
Particulate Analysis
Microscopic Count, Device	C0019A	230
Microscopic Count, Solution	C0020A	195
pH	C0021A	65
Refractive Analysis	C0022A	70
Specific Gravity	C0023A	75
Ultraviolet and/or Visible Scan	C0024A	80
Physicochemical Tests
Protein Assay, Latex
ASTM, D5712	C0025A	290
Bradford/Coomassie Blue	C0026A	245
Latex ELISA Antigenic Protein (LEAP) Assay	C0027A	145
Modified Lowry	C0028A	245
Scanning Electron Microscopy (SEM), per evaluation	C0029A	340
Specific Gravity ASTM D792	C0030A	Inquire
Surface Characterization by Microscopy	C0031A	Inquire
Tensile Strength, Elongation at Failure	C0032A	Inquire
Package Evaluation and Shelf Life Studies
Accelerated or Real Time Aging/ Incubation	C0033A	Inquire
ARO Package Burst& Creep Tests, up to 20 samples	C0034A	170
ARO Burst Test Only, up to 10 samples	C0035A	95
Dye Penetration Test, up to 10 samples	C0036A	145
Moisture Permeation of Multiple Use Containers	C0037A	440
Package Integrity Tests
Physical Testing, Seal Peel Test, 180 or 90 Degree	C0038A	Inquire
Physical Testing, Tensile, Elongation, Modulus	C0039A	Inquire
Biocompatibility of Packaging in Direct Contact With a Medical Device
Class I, Saline Extract (USP)	C0040A	320
Elution Cytotoxicity (USP)	C0041A	155
Limulus Amebocyte Lysate (USP)	C0042A	85
Physicochemical Tests, Water Extract (USP)	C0043A	190
USP Chemical Tests
Physicochemical Tests-Plastics, Complete, Aqueous Extract USP	C0044A	195
Partial, Per Test
Buffering Capacity	C0045A	65
Heavy Metals as Lead	C0046A	65
Non-Volatile Residue	C0047A	65
Residue on Ignition	C0048A	65
Physicochemical Tests-Elastomeric Closures, Complete	C0049A	245
Partial, Per Test
Heavy Metals	C0050A	65
pH Change	C0051A	65
Reducing Agents	C0052A	65
Total Extractables	C0053A	65
Turbidity	C0054A	65
Physicochemical Tests-Non-Aqueous (Isopropanol) Extract	C0055A	170
Partial, Per Test
Non-Volatile Residue	C0056A	65
Residue on Ignition	C0057A	65
Turbidity	C0058A	65
Ultraviolet Scan	C0059A	80
Water Tests, USP 23
Purified Water, Chemical Tests Only, Total Solids	C0060A	175
Purified Water, Chemical Tests Plus Bacteriological Purity	C0061A	220
Purified Water, Proposed USP, Total Organic Carbon, pH & conductivity	C0062A	105
Water for Injection, Chemical Tests Only, Total Solids	C0063A	175
Purified Water, Chemical Tests, Plus Bacterial Endotoxins	C0064A	240
Purified Water, Chemical Tests, Plus Particulates	C0065A	370
Purified Water, Chemical Tests, Particulates, Plus Bacterial Endotoxins	C0066A	420
Other	See Sales Associate or Call 361-3GETSEN

 

 

 

 

 

Other Testing

 

Test	Getsen Code	Fee Per Sample ($)
Non-DOT
Employee Pre-Employment Drug Screens
Full 10 Panel + Control (UID)	L01-0001	Inquire
Individual Drug for Drugs of Abuse	L01-0002	Inquire
DNA Parentage Test, Single Sample	L02-0001	Inquire
Other	See Sales Associate Call 361-3GETSEN

Copyright © 2004 Getsen, Inc.