SOP for Handling of Lysate for Endotoxin Testing : Pharmaceutical Guidelines

SOP for Handling of Lysate for Endotoxin Testing

Standard operating procedure to handle the lysate used in endotoxin testing

1.0 OBJECTIVE

To lay down a procedure for Handling of Lysate.

2.0 SCOPE

This SOP shall be applicable for Handling of Lysate.

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head – QA & QC

5.0 PROCEDURE

5.1 After receiving Lysate keep it at 2-8°C.
5.2 After reconstitution of lysate, transfer it into different depyrogenated assay tube which is depyrogenated as per SOP.
5.3 During depyrogenation all tubes covered with aluminum foil.
5.4 After transfer the Lysate recovered the tubes with aluminum foil and keep the tubes in the deep freezer.
5.5 Take the tubes as per daily requirement.

6.0 ABBREVIATION

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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