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.
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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 |
|
