LABORATORY TESTING
Bioburden Testing
Sterility Testing
VDmax Validation
Method 1 Sterilization Validation
Pyrogen (LAL) Testing
Biological Indicator Population Verification
Microbial Identification
Cytotoxicity Testing
Shelf Life Studies and Package Integrity Testing
DNase/RNase Testing
Cleaning and Disinfection Validation
(FTIR) Fourier-transform infrared spectrometer
Microbiological Water Testing
Autoclave Cycle Validation
Autoclave Cycle Qualification
Environmental Chamber/Oven IQ/OQ/PQ
Rent-A-Tech
Class 100 Controlled Environment Leasing
Specialized Microbiology Testing
BIOCOMPATIBILITY STUDIES
Cytotoxicity
Sensitization
Irritation/Intracutaneous
Acute Systemic Toxicity
Subchronic Toxicity
Genotoxicity
Implantation
Hemocompatibility
Chronic Toxicity
Carcinogenicity
Reproductive/Developmental
Biodegradation
STERILIZATION
E-beam Sterilization
Gamma Radiation
Ethylene Oxide (EtO)
MATERIALS ANALYSIS/CHARACTERIZATION
AES
AFM/SPM
XPS/ESCA
FTIR
GC/MS
FE SEM
SEM/EDS
FIB
TOF-SIMS
Raman
XRF
TXRF
Accelerator Techniques
RBS
PIXE
NRA
HFS
SIMS

 

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Download Sample Submission Form (Word Doc)

pdfHow To Submit Your Sample Submission Form (PDF)

Download Test Index (PDF)

 

 

BSI Registered

ISO Certificate
(PDF)

 

MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is ISO 9001:2000 certified and complies with U.S. GMP and Quality System Regulations. Our experts understand your needs for quality testing and timely, accurate results.

ENVIRONMENTAL MONITORING TESTING SERVICES CONSULTING

 

Laboratory Testing

Bioburden Testing - ISO 11737-1, USP <1231>
MicroMed tests for product bioburden to help establish sterilization validations accordance with ISO11737 and as part of in-process checks to help clients ensure their production processes are not compromising sterilization validations. In addition, MicroMed tests water samples for bioburden to ensure that water systems are performing within the required specifications.

Test Code Test Description Minimum Sample Requirements Turnaround time
BI-001 Aerobic Bacteria

Per related validation documenting
ISO 11137 n=10 or based on client sampling plan

7-9 days
BI-002 Aerobic & Fungi 7-9 days
BI-003 Aerobic & Spore 7-9 days
BI-004 Aerobic, Spores & Fungi 7-9 days
BI-005 Bioburden Validation-Spore Inoculation

Sampling plan based on intended use.

7-9 days
BI-006 Bioburden Extraction Efficiency-Exhaustive Rinse 7-9 days
BI-007 Bioburden-Direct Filtration (100ml sample required for water) 7-9 days
BI-008 Blender Method 7-9 days


Sterility Testing - USP <71>
MicroMed performs sterility testing of devices and solutions in compliance with USP<71>. MicroMed performs all tests in a state of the art Class 100 Clean Room in the confines of a biological safety cabinet to reduce the risk of false positives. Our technicians use only sterile gowning supplies and monitor the CER routinely to ensure that it is operating within specifications.

Bacteriostasis/Fungistasis testing is performed in compliance with USP <71> to validate that samples do not possess antimicrobial activity that may cause false negatives in sterility samples.

All EtO sterilization related spore strips are processed as soon as possible priority items upon receipt because we know your timelines are important for lot release. We can also verify the manufacturer’s population claim for spore strips.

Test Code Test Description Minimum Sample Requirements Turnaround time
ST-001 Bacteriostasis/Fungistasis, USP Method

Per USP or ISO depending on lot size Chart
Based on chamber size per ISO 11135 Chart

3-5 days

ST-002 Direct Transfer Method-per device or solution

14 days

ST-003 Direct Transfer Method-Spore Strips

7 days

ST-004 Growth Promotion Test-of Cultured Media

3-5 days

ST-005 Autoclave Cycle

7-9 days

ST-006 Direct Transfer-Biological product 7-9 days
MF-001 Manipulation Fee-section or disassembly of sample Immediate

VDmax Validation - ISO11137-2
VDmax, or ISO11137-2 method validates a 15 or 25 kGy minimum sterilization dose. This method is limited to a maximum bioburden of 1.5 colony-forming units (CFU) per device for VDmax 15 and 1,000 CFU per device for VDmax 25 kGy. VDmax requires a low number of test samples thus reducing costs. VDmax calculates the highest verification dose possible for your product, which results in a reduced risk of failure. A 25.0 kGy minimum sterilization dose is standard at most irradiation facilities. The 15 kGy VDmax dose method is for sensitive products that can be successfully sterilized at 15 kGy.

Test Code Test Description Minimum Sample Requirements Turnaround time
VD-015 VDmax Validation 15kGy

3 lots of 20 units plus 3 units for bioburden validation and 3 for Bacti Fungi Statis testing

30 days
VD-025 VDmax Validation 25kGy 30 days

Method 1 Sterilization Validation - ISO 11137
Method 1 Sterilization Validation method validates a minimum radiation sterilization dose.

Test Code Test Description Minimum Sample Requirements Turnaround time
M1-015 Method 1 Sterilization Validation

3 lots of 110 units minimum plus 3 units for bioburden validation and 3 for Bacti Fungi Statis testing:  Note 100 units for sterility testing.

30 days

Pyrogen (LAL) Testing - FDA Guideline, USP <85>, AAMI ST72:2002
MicroMed performs pyrogen testing in accordance with FDA guidelines to determine the level of bacterial endotoxin present on devices. MicroMed provides kinetic turbidimetric, chromogenic and gel clot methods and our experts can help determine sources of endotoxin when specifications are exceeded. In addition, MicroMed tests water samples for endotoxin contamination to ensure that water systems are performing within the required specifications. For an additional charge, results can be provided the day samples are received or on the weekend if the laboratory is notified in advance.

Test Code Test Description Minimum Sample Requirements Turnaround time
PY-001 Pyrogen (LAL) Kinetic Turbidimetric

For medical Devices:
Lot size 1-30=2
30-100=3
Over 100=3%
Max =10

1 day
PY-002 Pyrogen (LAL) Chromogenic 1 day
PY-003 Water Pyrogenicity Testing 1 day
PY-004 Endotoxin spiked vials or components

Medical Device: 10 units per each lot pooled-
30 units=3 groups of 10

1 day
PY-005 LAL Product Validation-Inhibition & Enhancement (3 lots) 1 day
PY-006 Pyrogen Gel Clot 1 day

Biological Indicator Population Verification - USP <55>, ISO 11138-1
We can verify the manufacturer’s population claim for spore strips in support of EtO Sterilization Validations.

Test Code Test Description Minimum Sample Requirements Turnaround time
BP-001 USP 3 strips 2 days
BP-003 Dual Species, USP 2 days


Microbial Identification
MicroMed can characterize and identify bacterial or fungal contaminants associated with Environmental Monitoring, Sterility, and Bioburden Testing.

Test Code Test Description Minimum Sample Requirements Turnaround time
ID-001 Bacterial Identification, to genus

We recommend some characterization of Environmental Monitoring and Bioburden data on a regular basis per guidance documentation

3-14 days

ID-002 Bacterial Identification, to species

3-14 days

ID-003 Fungi, to genus (mold and yeast)

3-14 days

ID-004 Gram Stain

1 day


Cytotoxicity Testing - USP <87>, ISO 10993-5
Cytotoxicity Testing is performed in compliance with ISO 10993-05 using mouse fibroblast L-929 Cells. Clients use this service to release raw materials and during non-conformance investigations to ensure products are not contaminated.

Test Code Test Description Minimum Sample Requirements Turnaround time
CY-002 Cytotoxicity Testing-MEM Elution, USP (48 hours) 0.6 grams 3 days
CY-004 Cytotoxicity Testing-MEM Elution, ISO (48 hours) 1.8 grams 3 days
CY-005 Micro-Cytotoxicity Testing-MEM Elution, USP
This test is designed for products that are lightweight and expensive.
We only require 0.2 grams of material to complete this test.
0.2 grams 3 days
CY-006 Micro-Cytotoxicity Testing-ISO 0.2 grams 3 days
CY-007 Agar Overlay >100mm2 3 days
CY-008 Direct Contact >100mm2 3 days



Shelf Life Studies and Package Integrity Testing - ISO 11607, ASTM F1929, ASTM 1140
MicroMed maintains accelerated aging ovens set at the common temperatures used for medical device studies (45-65ēC). In addition to the aging of the samples, MicroMed can perform a variety of tests to help support shelf life and packaging validation studies that are usually associated with shelf life studies.

Test Code Test Description Minimum Sample Requirements Turnaround time
PA-001 Dye Penetration

Based on clients statistics, supply plan/confidence reliability

1 day
PA-002 Burst Test 1 day
PA-003 Burst & Creep Test 1 day
PA-004 Accelerated or Real Time Aging 1 day
PA-005 Creep Test 1 day
PA-006 Bubble Emission 1 day

 

DNase/RNase Testing
DNase and RNase are ubiquitous in the environment, and in some biological materials. They are present in relatively high concentrations.  RNase frequently contaminates common molecular biological reagents such as reaction buffers, enzymes such as reverse transcriptase, RNA polymerase, and buffers for RNA purification and storage.  DNase degrades DNA and its presence is a threat to many molecular biology experiments.  MicroMed can test for DNase and RNase contaminants.  Certify plastics, enzymes, solutions and other biomaterials as "DNase/RNase-free" prior to DNase/RNase-sensitive applications such as PCR.

Test Code Test Description Minimum Sample Requirements Turnaround time
DR-001 DNase/RNase testing (1-4 samples) Inquire 2 days
DR-002 DNase/RNase testing (5-100 samples) 2 days

 

Cleaning and Disinfection Validation – reusable device – AAMI, TIR 12, AAMI, TIR 30
Reusable medical devices must undergo cleaning and/or disinfection between patients. MicroMed can perform validation studies to ensure that cleaning/disinfection methods are adequate. Such studies involve inoculation of the device and are used to simulate manufacturer recommended cleaning instructions. In addition to the microbiological testing, validation includes cytotoxicity testing to ensure that residuals from the cleaning and disinfection process have been removed.

Test Code Test Description Minimum Sample Requirements Turnaround time
RD-001 Cleaning and Disinfection Validation -reusable device Inquire 30 days

 

(FTIR) Fourier-transform infrared spectrometer
(Fourier Transform Infrared Spectroscopy or Full Spectrum Scan) is a test where infrared light absorption is used for assessing levels of equivalency among samples from lots. The equipment provides a record of the infrared absorbency or transmittance of a sample as a function of wave number. The frequencies at which absorption occurs may indicate the type of functional groups present in the substance.

Test Code Test Description Minimum Sample Requirements Turnaround time
FT-001 Fourier Transform Infrared Spectroscopy (FTIR) Inquire 4 days

 

Microbiological Water Testing
MicroMed tests for bacterial safety of water samples by performing direct filtration of water samples. A kit containing a sterile vial can be provided to collect the water samples. Samples must be sent back to the lab overnight to provide accurate results. MicroMed can perform total heterotrophic testing and total coliform testing.

Test Code Test Description Minimum Sample Requirements Turnaround time
BI-007 Direct Filtration – total heterotrophic count Inquire 9 days
BI-009 Direct Filtration – total coliform count
A. Total count
B. If positive – Conformity test
7 days
+ 4 days for confirmation

 

Autoclave Cycle Validation - HTM 2010, EN 285, EN17765, PDA Monograph and ISO standards
Our specialty is IQ/OQ/PQ, Cycle development and PQ’s of Autoclaves. Performance qualification (validation) is an accurate method of assessing and maximizing the efficiency of your autoclave cycles and your individual load types.

Test Code Test Description Minimum Sample Requirements Turnaround time
CV-001 Autoclave Cycle Validation Inquire 2 weeks

 

Autoclave Cycle Qualifications - ANSI/AAMI/ISO 11134-1993
MicroMed can qualify a standard cycle for use on your product per ANSI/AAMI/ISO 11134-993 this cycle can then be duplicated at the final use site.

Test Code Test Description Minimum Sample Requirements Turnaround time
CQ-001 Autoclave Cycle Qualification Inquire 2 days

 

Environmental Chamber/Oven IQ/OQ/PQ
Our specialty is developing IQ/OQ/PQ protocols for Environmental Chambers in need of temperature/performance mapping. The Performance Qualification ensures shelf life studies are performed in chambers that maintain temperatures over the life of the study without concerns of hot or cold spots within the chamber.

Test Code Test Description Minimum Sample Requirements Turnaround time
EQ-001 Environmental Chamber/Oven Qualification Inquire 2 weeks

 

Rent-A-Tech
Do you have a special project that will only last for a day or two where you need some extra help? MicroMed Labs can help augment your staffing needs for a day or two with our rent a tech program. This is a limited offer to Bay Area clients only.

Class 100 Controlled Environment Leasing
Our Class 100 controlled environment room (CER) with biological safety cabinet is available for you to rent. We can supply sterile gowning supplies and other consumables required for your cleanroom job. Please contact us for an estimate.

Specialized Microbiology Testing
MicroMed can develop protocols and reports to meet your specific testing needs including: reusable device cleaning/disinfection validations, antimicrobial effectiveness testing, and DNase/RNase testing.

 

MATERIALS ANALYSIS/CHARACTERIZATION

AES
Auger Electron Spectroscopy
 
AFM/SPM
Atomic Force Microscopy
Scanning Probe Microscopy

 
XPS/ESCA
X-ray Photoelectron Spectroscopy/
Electron Spectroscopy for Chemical Analysis

 
FTIR
Fourtier Transform Infrared Spectroscopy
 
GC/MS
Gas Chromotography/Mass Spectrometry
 
FE SEM
Field Emission Scanning Electron
 
SEM/EDS
Scanning Electron Microscopy/Energy Dispersive X-ray Spectroscopy
 
FIB
Focused Ion Beam
 
TOF-SIMS
Time-Of-Flight Secondary Ion Mass Spectrometry
 
Raman
Raman Spectroscopy
 
XRF
X-ray Fluorescence
 
TXRF
Total Reflection X-ray Fluorescence



Accelerator Techniques

RBS
Rutherford Backscattering Spectrometry
 
PIXE
Particle Induced X-ray Emission
 
NRA
Nuclear Reaction Analysis
 
HFS
Hydrogen Forward Scattering Spectrometry
 
SIMS
Secondary Ion Mass Spectrometry