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SOP on Confirmation of Labeled LAL Reagent Sensitivity

  • SOP on Confirmation of Labeled LAL Reagent Sensitivity

  • Objective

To lay down the procedure Confirmation of Labeled LAL Reagent Sensitivity.

 Scope

This SOP is applicable for Confirmation of Labeled LAL Reagent Sensitivity tested in Microbiology Laboratory. (Pharmaceutical Company Name).

  • Responsibility
    • Microbiologist or above of Microbiology Laboratory.
    • Head – Microbiology section / Nominee.
  • Accountability
    • Head – Quality Control I Nominee.
    • Head – Quality Assurance.

 Abbreviations and Definitions

SOP          : Standard operating procedure

No.            : Number

QC            : Quality Control

QA            : Quality Assurance

LAL          : Limulus amoebocyte Lysate.

  • Procedure
    • Confirm the labeled claim sensitivity of each lot of LAL reagent received in different consignments, using at least I vial / lot. Also confirm the sensitivity, when there is any change in the experimental conditions.
    • Prepare a series of two-fold dilutions of the CSE (Controlled Standard Endotoxin) in LAL reagent water to give concentrations of 2λ, λ, 0.5 λ and 0.25 λ.
    • “λ.”is labeled claim sensitivity of LAL.
    • Perform the test on the four standard concentrations in quadruplicate and include negative controls.
    • Mix 0.1 ml of the LAL Reagent with 0.1 ml of one of the standard solutions in each test tube.
  • Incubate the reaction mixture for a constant period according to directions of the LAL reagent manufacturer (usually at 37 ± 100 for 60 ± 2 minutes), avoiding vibration.
  • To test the integrity of the gel, take each tube in turn directly from the incubator and invert it through about 180° in one smooth motion. If a firm gel has formed that remains in place upon inversion, record the result as positive (+Ve). Result is negative if an intact gel is not formed.
  • The test is not valid unless the lowest concentration (0.25 λ) of the standard solutions shows a negative result in replicate tests.
  • The end point is the last positive test in the series of decreasing concentrations of endotoxin. Calculate the mean value of the logarithms of the end point concentration and then the antilogarithm of the mean value using the following equation
  • Geometric Mean Endpoint Concentration = antilog (Ze I t)
  • where Ze is the sum of the and then the anti of dilution of the log end point concentrations of the dilution series used, and f is the number of replicate test tubes.
  • The geometric mean endpoint concentration is the measured sensitivity of the LAL Reagent (in EU / mL). If this is not less than 0.5 λ and not more than 2 λ,

the labeled sensitivity is confirmed and is used in tests performed with this lysate.

  • Record the details and results of the test as per Annexure No.: (Format No. :).
  • Forms and Records (Annexures)
    • Confirmation of ‘LAL’ Label Claim Sensitivity
  • Distribution
    • Master copy        –       Quality Assurance
    • Controlled copies –       Quality Assurance, Production, Quality Control, Stores, Engineering   and Human Resource
  • History:
Date Revision Number
Reason for Revision
00   NEW SOP

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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