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
Download Sample Submission Form (PDF) Download Sample Submission Form (Word Doc) How To Submit Your Sample Submission Form (PDF) Download Test Index (PDF)

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.

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.

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.

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.

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

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.

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.

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

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.

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.

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.

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.

(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.

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.

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.

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.

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.

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