Better Endotoxin Testing Booklet
Exciting news! Our free 116-page eBook on “Better Endotoxin Testing” is available now! Whether you're new to the field or a seasoned pro, this comprehensive guide is packed with valuable insights to elevate your endotoxin testing practices. Click the link below to download your copy today:
?In this eBook, you'll find four primary chapters covering everything from the fundamentals of endotoxin testing to the best practices for ensuring accurate and compliant results. Perfect for training new analysts or refreshing your own knowledge, this can serve as a resource for anyone in the pharmaceutical or medical device industries.
?Topics covered in each chapter include:
·??????? Introduction to endotoxin testing
·??????? A well-supported test
·??????? A well-developed test
·??????? A well-performed test
?This booklet can be used as an introduction or outline for training new analysts or a refresher for experienced analysts or laboratory management.?
?The topics covered in each of the four chapters include:
?CHAPTER 1 - Introduction
1.??Endotoxin as a unique detection marker
2.??Definition & description of endotoxin
3.??Structure of endotoxin
4.??How endotoxin is organized in the Gram negative outer membrane
5.??Endotoxin as a potent pyrogen
6.??Additional endotoxin activities affecting the body
7.??Limulus-based testing—the first endotoxin-specific test
8.??Making LAL using horseshoe crabs
9.??Making rFC and sparing the crabs
10.??Interfering factors in testing
11.?The critical importance of LAL alternatives like rFC
12.?How rFC is specific to endotoxin—and why LAL is not
13.?Regulating drugs for endotoxin testing
14.?Setting up a new test method with SOPs
15.?Why SOPs are so important in a lab
16.?Biologic drugs vs. traditional drugs
17.?The critical difference between absorbance and fluorescence
18.?The importance of an FDA 483 letter
19.?Test verification vs. validation
20.??Successful analyst training—time to roll up your sleeves
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CHAPTER 2 - A well-supported test
21. Has a recipe for success
22. Follows up-to-date procedures & regulations
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23. Documents everything well
24. Tracks all samples entering lab—an FDA (21 CFR Part 211) expectation
25. Includes the requirements for “data integrity”
26. Is supported by ancillary data—sample list included
27. Uses well-maintained equipment—“to-do” list included
28. Uses common, qualified labware
29. Includes training documentation for all analyst activities
30. Extends to the 3 P’s: People, Process, and Product
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CHAPTER 3 – A well-developed test
31. Is developed by a specific process—list included
32. Uses the “best” test
33. Performs at an appropriate specification
34. Overcomes significant interference (NIC + I/E)
35. Has low variability
36. Follows an important document—the routine protocol
37. Gives an ambiguous result—learn how to prevent unambiguous results
38. Ensures pH range is acceptable
39. Uses rFC—especially for water testing
40. Acknowledges when additional tools are needed
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CHAPTER 4 – A well-performed test
41. The interface checklist for a well-performed test
42. Preparation of CSE/RSE and resulting dilution series
43. Preparation of the sample/addition to plate
44. Save your sample post test
45. Result calculation & the best way to track
46. Troubleshooting issues like a series of non-performing assays
47. Avoiding false positives with Beta glucans
48. The benefits of automation—ENDOZYME II GO?
49. Masking, demasking, and overcoming LER
50. rFC/LAL comparison studies
51. Finally, no wasting reagents
??Don't miss out – download your copy today and take your endotoxin testing to the next level!
PhD Scholar
8 个月Well done Sir
Microbiologist | Quality Assurance | Medical Device An advocate for personal development, leadership and life productivity
9 个月Thanks for sharing!