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
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

 

 

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

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

 

 

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)