1. 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 Next

2. 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 Scan

3. Bacterial Endotoxins Test (BET) Interesting Facts Copyright Nelson Laboratories 20103WHAT 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. NextScan

4. More information on BET Interesting Facts Copyright Nelson Laboratories 20104 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. BackScan

5. Biocompatibility and Subcontracting Interesting Facts Copyright Nelson Laboratories 20105WHAT 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. NextScan

6. Pharmacy Interesting Facts Copyright Nelson Laboratories 20106WHAT 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. NextScan

7. Microbiology Interesting Facts Copyright Nelson Laboratories 20107WHAT 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. NextScan

8. Media Interesting Facts Copyright Nelson Laboratories 20108WHAT 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. NextScan

9. Product Sterility Interesting Facts Copyright Nelson Laboratories 20109WHAT 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. NextScan

10. Chemistry Interesting Facts Copyright Nelson Laboratories 201010WHAT 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. NextScan

11. Ethelyne Oxide (EO) Interesting Facts Copyright Nelson Laboratories 201011WHAT 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. NextScan

12. Healthcare Sterilization Interesting Facts Copyright Nelson Laboratories 201012WHAT 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. NextScan

13. Healthcare Cleaning Interesting Facts Copyright Nelson Laboratories 201013WHAT 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. NextScan

14. Bioburden Interesting Facts Copyright Nelson Laboratories 201014WHAT 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. NextScan

15. Packaging Interesting Facts Copyright Nelson Laboratories 201015WHAT NextScan 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

16. Packaging Tests Copyright Nelson Laboratories 201016 Scan 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.

17. Protective Barriers Interesting Facts Copyright Nelson Laboratories 201017WHAT 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. NextScan

18. IDs Interesting Facts Copyright Nelson Laboratories 201018WHAT 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. NextScan