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Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation In part two of this four-part series, subject matter expert Yadnyesh Patel shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test. https://lnkd.in/emS-PJnA #laltest #bacterialendotoxin

Bacterial Endotoxin Testing, Part 2 In Yadnyesh Patel's last article, he provided an overview of bacterial endotoxin testing (BET). In this second article of a planned series, he shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (#LAL) test. #medicaldevice #meddevice #implantablemedicaldevice https://lnkd.in/dzMC-yVg

Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection In this article, Yadnyesh Patel discusses #depyrogenation and calculating endotoxin limits and maximum valid dilution. In this article, I provide a deep dive into the following series of tests performed during BET analysis: - labeled lysate sensitivity test - non-interfering dilution determination (NID) - validation for interfering factor - test for bacterial endotoxin of samples/products. Read the full article: https://lnkd.in/eRdbJba8 #endotoxin #medicaldevice #meddevice

Medical Microbiology Gram Staining: Gram staining is a microbiological technique that distinguishes bacteria based on cell wall properties. Bacteria are first stained with crystal violet, fixed with iodine, then decolorized with alcohol or acetone. Gram-positive bacteria retain the purple stain due to a thick peptidoglycan layer, while gram-negative bacteria, with a thinner peptidoglycan layer, appear red or pink after counterstaining with safranin. This method is crucial for identifying bacteria and guiding antibiotic treatment.

Addendum 2024 to IP 2022 (Effective date 1st July 2024) Addendum related to (Blood and Blood Related Products) o Anti- B Blood Grouping Serum o Anti -AB Blood Grouping Reagent o Antithrombin III Concentrate o Blood Grouping Lectins Anti-H o Human Albumin o Human Normal Immunoglobulin for Intravenous use Addendum related to Microbiology New addition o Guidelines on the Bacterial Endotoxins Tests (2.2.33) Revisions and Upgradations oEffectiveness of Antimicrobial Preservatives (2.2.2) o Microbial Contamination in Nonsterile Products (2.2.9) o Design and Development of Biological Assay and its Validation (2.2.31).

McFarland standards are essential in microbiology laboratories. They serve as reference points for adjusting the turbidity of bacterial suspensions, ensuring that the number of bacteria falls within a specific range for standardized microbial testing1. Let’s delve into the details: Purpose: McFarland standards are used primarily for antibiotic susceptibility testing. By measuring the minimum inhibitory concentration, these standards help determine whether bacteria are resistant or susceptible to specific antimicrobial agents1. Original McFarland Standards: The original standards were created by mixing barium chloride and sulfuric acid. The resulting barium sulfate precipitate caused turbidity in the solution. A 0.5 McFarland standard is prepared by mixing 0.05 mL of 1.175% barium chloride dihydrate (BaCl₂•2H₂O) with 9.95 mL of 1% sulfuric acid (H₂SO₄)1. Modern McFarland Standards: Nowadays, McFarland standards are prepared from latex particle suspensions, which enhance shelf life and stability. These standards can be visually compared to bacterial suspensions in sterile saline or nutrient broth. Adjustments can be made: If the bacterial suspension is too turbid, dilute it with more diluent. If it’s not turbid enough, add more bacteria1. McFarland Nephelometer Standards: Here’s a comparison of different McFarland standards: No. 0.5: 1.5 × 10⁸ CFU/mL, 74.3% transmittance, absorbance at 600 nm: 0.08 to 0.1 No. 1: 3.0 × 10⁸ CFU/mL, 55.6% transmittance, absorbance at 600 nm: 0.257 No. 2: 6.0 × 10⁸ CFU/mL, 35.6% transmittance, absorbance at 600 nm: 0.451 No. 3: 9.0 × 10⁸ CFU/mL, 26.4% transmittance, absorbance at 600 nm: 0.582 No. 4: 12.0 × 10⁸ CFU/mL, 21.5% transmittance, absorbance at 600 nm: 0.6691 Remember, McFarland standards play a crucial role in ensuring accurate microbial testing results! #Microbiology #MIC

Bacterial Endotoxin Limit - A very critical and decisive parameter in maintaining the quality of the sterile drug products. The key terms to learn include 👉 Endotoxins 👉 Pyrogens 👉 K/M 👉 LAL Check out this interesting article on #bacterialendotoxintest https://lnkd.in/gRKGkTqE #learning #development #bet #nda #anda #bla #maa #ands #sterile #parenteral #fda #usfda #guidance #relearn #unlearn #carrer #upskilling #upskill #reskilling #careeradvancement #training #learning #education #skills #careergrowth #careerdevelopment #skilldevelopment #professionaldevelopment #leadership #onlinelearning #upskillyourself #inpharmedia

⭕ Normal saline preparation.... ⭕ Autoclave Sterilization ..... 👉Normal saline 🧪 is 0.9% saline. This means that there is 0.9 G of salt (NaCl) per 100 ml of solution or 9 G per liter.... 👉Normal saline contains electrolytes (sodium and chloride ions) which dissociate in solution. Sodium ions are the main electrolytes of extracellular fluid, integral in the distribution of fluids and other electrolytes.> Another important ion is chloride, which serves as a buffering agent within the lungs and tissues.... ⭕Normal Saline can be used in the following microbiology applications: 👉Solvent, washing agent for cells/bacteria/specimen, buffer in aseptic techniques and plaque assays, titer assays).... 💡Normal saline solution is routinely used as a diluent to adjust the turbidity of bacterial cell suspensions to help maintain cell integrity and viability....

In most of the laboratories we will see the use of 70%isopropyl alcohol (IPA) rather than 99% here is the reason why they are using 70 %isopropyl alcohol (IPA), 70% isopropyl alcohol (IPA) is commonly used as a disinfectant rather than 99% IPA because the 70% solution is more effective at penetrating and destroying microbial cell walls. The presence of water in the 70% solution helps in this process. Water acts as a carrier that facilitates the alcohol's penetration into the cell, making it more effective in killing bacteria and viruses. In contrast, 99% IPA can be too concentrated, causing the alcohol to evaporate too quickly and not allowing sufficient time for effective microbial kill. Therefore, 70% IPA is generally preferred for disinfection purposes. #disinfectant #microbiology