Title: Standard Operating Procedure for Bacterial Endotoxin Test (BET)

Objective: To establish a standardized procedure for performing Bacterial Endotoxin Testing (BET) to
ensure product safety and compliance with regulatory requirements.

Scope: This SOP applies to all personnel involved in BET testing at [Your Organization's Name].

Responsibilities:

[Name], [Job Title]: Responsible for performing BET tests.

[Name], [Job Title]: Responsible for reviewing and approving BET test results.

Procedure:

Preparation of Test Samples

Describe the process for collecting and preparing test samples.

BET Test Procedure

Outline the step-by-step procedure for performing the BET, including reagent preparation,
incubation, and measurement.

Data Recording and Analysis

Describe how test data should be recorded, and include criteria for acceptance or rejection of
results.

Reporting

Explain how results should be documented and reported, including any deviations from the standard
procedure.

Documentation and Archiving

Detail the process for maintaining records and archiving BET test data.

Quality Control and Calibration

Describe how equipment used in BET testing will be calibrated and maintained.

Training and Competency

Explain the training and competency requirements for personnel involved in BET testing.