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

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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

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