LABORATORY TESTING
Bioburden Extraction Efficiency
Bioburden Testing
Water Testing – Bioburdens/Coliforms
USP 61 Microbial Enumeration
USP 61/.62 Method Suitability
Bacteriostasis/Fungistasis
Microbial Identification
Sterility Testing
Sterility Validation
VDmax Validation
Dose Audits
Cleaning and Disinfection Validation
Autoclave Cycle Qualification
Autoclave Cycle Validation
Endotoxin/Pyrogen (LAL) Validation
Endotoxin/Pyrogen (LAL) Testing
Cytotoxicity Testing
Biological Indicator Population Verification
DNase/RNase Testing
Shelf Life Studies and Package Integrity Testing
Environmental Chamber/Oven IQ/OQ/PQ

 

 

MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is in compliance with the ISO 13485 quality system, 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


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



 

Download Sample Submission Form (PDF)

Download Sample Submission Form (Word Doc)

pdfHow To Submit Your Sample Submission Form (PDF)

 

DEKRA-ISO-9001

ISO Certificate
(PDF)