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.

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• 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.

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Bacterial Endotoxins Test (BET)

Interesting Facts

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.

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More information on BET

Interesting Facts

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.

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Biocompatibility and Subcontracting

Interesting Facts

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.

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Pharmacy

Interesting Facts

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.

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Microbiology

Interesting Facts

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.

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Media

Interesting Facts

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.

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Product Sterility

Interesting Facts

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.

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Chemistry

Interesting Facts

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.

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Ethelyne Oxide (EO)

Interesting Facts

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.

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Healthcare Sterilization

Interesting Facts

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.

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Healthcare Cleaning

Interesting Facts

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.

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Bioburden

Interesting Facts

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.

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Packaging

Interesting Facts

Copyright Nelson Laboratories 2010 15

WHAT

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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, compatibility with sterilization process, shelf life limitations

Packaging Tests

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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 11607The 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.

Protective Barriers

Interesting Facts

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.

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IDs

Interesting Facts

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.

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