Procedure for Flowability Testing of Powders
1) Purpose
The purpose of this SOP is to outline the procedure for determining the flowability of powders to ensure consistent and efficient handling during the manufacturing process.
2) Scope
This SOP applies to all powder batches prepared for pharmaceutical production within the manufacturing facility.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting flowability testing and ensuring compliance with this SOP.
Production Department: Responsible for providing powder samples for testing and maintaining process parameters.
4) Procedure
4.1 Sampling:
4.1.1 Collect representative samples of the powder according to the sampling plan.
4.1.2 Ensure samples are taken from different batches to obtain a uniform representation.
4.2 Equipment Preparation:
4.2.1 Calibrate the flowability tester (e.g., flowmeter or funnel) as per the manufacturer’s instructions.
4.2.2 Ensure the equipment is clean and free from previous residues.
4.3 Flowability Determination:
4.3.1 Weigh an appropriate amount of the sample (e.g., 100 grams).
4.3.2 Pour the sample into the flowability tester funnel.
4.3.3 Allow the powder to flow freely through the funnel.
4.3.4 Measure the time taken for the entire sample to flow through the funnel.
4.3.5 Record the flow time.
4.4 Calculation:
4.4.1 Calculate the flow rate using the formula: Flow Rate = Mass / Flow Time.
4.4.2 Assess the flowability based on the flow rate and compare it with standard values.
4.5 Acceptance Criteria:
4.5.1 The powder is considered to have acceptable flowability if the flow rate falls within the specified range (e.g., 10-20 grams/second).
4.6 Documentation:
4.6.1 Document all results and calculations in the Flowability Test Record.
4.6.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Flowability Test Record
Calibration Record for Flowability Tester
Sampling Plan Document
7) Reference, if any
USP <1174> – Powder Flow
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0