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
Microbiological Water Testing
Autoclave Cycle Validation
Autoclave Cycle Qualification
Environmental Chamber/Oven IQ/OQ/PQ
BIOCOMPATIBILITY STUDIES
Cytotoxicity
Sensitization
Irritation/Intracutaneous
Acute Systemic Toxicity
Subchronic Toxicity
Genotoxicity
Implantation
Hemocompatibility
Chronic Toxicity
Carcinogenicity
Reproductive/Developmental
Biodegradation

 

 

 

MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is ISO 9001:2008 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

 

Test Services

Biocompatibility Studies

Irritation/Intracutaneous - ISO 10993-10
Determines how irritable a product or compound is to the body. Studies should be made in combination with how the product or compound will be used and effected areas should be tested to determine the effect over time.

Test Code Test Description Minimum Sample Requirements Turnaround time
IT-GLP

Irritation Test -Intracutaneous Injection Assay, Polar and Non-Polar Extracts Included, GLP Compliant

Sample needed: 240 cm2 if sample is < 0.5 mm thick, 120 cm2 if sample is > 0.5 mm thick, 8 grams, 10 mL

3-4 weeks

IT-NGLP

Irritation Test -Intracutaneous Injection Assay, Polar and Non-Polar Extracts Included, Non-GLP Compliant

3-4 weeks

 

 

Download Sample Submission Form (PDF)

Download Sample Submission Form (Word Doc)

pdfHow To Submit Your Sample Submission Form (PDF)

 

BSI Registered

ISO Certificate
(PDF)