This tour will help you understand the various tests that are performed here There are 13 labs that complete testing using the latest biomedical technology Copyright Nelson Laboratories 2010 1 Next ID: 274685
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Slide1
Welcome to Nelson Laboratories
This tour will help you understand the various tests that are performed here.There are 13 labs that complete testing using the latest biomedical technology.
Copyright Nelson Laboratories 2010
1
NextSlide2
During the virtual tour you can choose to visit the labs in any order.
Simply find and scan the QR code near the lab you want to know more about.
Copyright Nelson Laboratories 2010
2
ScanSlide3
Bacterial Endotoxins Test (BET)
Copyright Nelson Laboratories 2010
3
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide4
More information
on BET
Copyright Nelson Laboratories 2010
4
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide5
Biocompatibility and Subcontracting
Copyright Nelson Laboratories 2010
5
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide6
Pharmacy
Copyright Nelson Laboratories 2010
6
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide7
Microbiology
Copyright Nelson Laboratories 2010
7
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide8
Media
Copyright Nelson Laboratories 2010
8
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide9
Product Sterility
Copyright Nelson Laboratories 2010
9
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide10
Chemistry
Copyright Nelson Laboratories 2010
10
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide11
Ethelyne
Oxide (EO)
Copyright Nelson Laboratories 2010
11
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide12
Healthcare Sterilization
Copyright Nelson Laboratories 2010
12
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide13
Healthcare Cleaning
Copyright Nelson Laboratories 2010
13
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide14
Bioburden
Copyright Nelson Laboratories 2010
14
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide15
Packaging
Copyright Nelson Laboratories 2010
15
WHAT
The Packaging Department is responsible for assisting material suppliers and medical device manufacturers with evaluating package properties based on the following characteristics:
Microbial
Barriers,
Biocompatibility and toxicological
specifications,
Physical
and chemical
properties, Compatibility
with sealing, forming
process,
c
ompatibility
with sterilization
process,
s
helf
life limitations Slide16
Packaging Tests
Copyright Nelson Laboratories 2010
16
Top Tests:
Seal Peal:
The seal peel tensile test determines the strength of the seal at a specific place on the package. This can be helpful in setting the sealing parameters. This test method conforms to the standard covered in ISO 11607 “Packaging for terminally sterilized medical devices.”
Burst Testing:
based
off of standards ASTM F1140 and ASTM F2054, AMMI/ANSI/ISO 11607
The burst test determines package strength by pressurizing package until it bursts. This test method is defined in ASTM F1140 and conforms to ISO 11607 “Packaging for terminally sterilized medical devices.
Bubble Emission Testing:
The bubble emission test is used to determine the package integrity. This test method covers the bubble emission test as defined in ASTM2096-04.Slide17
Protective Barriers
Copyright Nelson Laboratories 2010
17
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.Slide18
IDs
Copyright Nelson Laboratories 2010
18
WHAT
WHY
HOW
In the
Bacterial Endotoxins Test (BET)
Lab we use LAL reagents derived from the blood of the horseshoe crab to detect and quantify bacterial endotoxin; a component of the cell wall of Gram negative bacteria.
Endotoxin
has the ability to remain toxic after sterilization, so any medical devices
or pharmaceutical
products in contact with the circulatory system, lymphatic system, or cerebrospinal fluid needs to be tested for the presence of endotoxin.
Medical devices are prepared for testing by extraction them in endotoxin free water. Depending on the intended use of the device it will either be immersed in extraction liquid, or the relevant fluid path will be flushed. Pharmaceutical products are dissolved or diluted in an appropriate solvent. After sample preparation the extract or test solution will be combined with LAL reagent in a 96 well
microplate
and allowed to react. The reaction is measured and compared agents a standard curve we make of known amounts of endotoxin.