Procedure for Water Absorption Testing in Dressings
1) Purpose
The purpose of this SOP is to outline the procedure for testing water absorption in dressings to ensure they meet specified absorption capacity requirements.
2) Scope
This SOP applies to all types of dressings requiring water absorption testing as part of quality control measures to assess product performance and adherence to specifications.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing water absorption testing.
Quality Assurance (QA) Department: Responsible for review and approval of water absorption testing procedures and results.
Manufacturing Department: Responsible for providing dressing samples and support during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Cut dressing samples into standardized sizes as per specifications.
4.1.2 Ensure samples are flat and free from wrinkles or folds.
4.2 Test Setup:
4.2.1 Place each dressing sample on a clean, dry surface.
4.2.2 Weigh each sample accurately using a calibrated balance and record initial weights (W1).
4.3 Water Absorption:
4.3.1 Immerse each dressing sample in a container filled with distilled water.
4.3.2 Allow the dressing to absorb water for a specified period.
4.3.3 Remove the dressing from water and gently blot excess surface water using absorbent paper.
4.4 Measurement:
4.4.1 Weigh each dressing sample again after absorption (W2).
4.4.2 Calculate the water absorption capacity using the formula: Absorption = (W2 – W1) / W1 * 100%.
4.5 Reproducibility Testing:
4.5.1 Repeat water absorption testing on additional dressing samples to confirm consistency.
4.5.2 Ensure agreement in absorption capacity measurements across multiple tests.
4.6 Data Analysis:
4.6.1 Compile and review water absorption testing data, including absorption capacity calculations.
4.6.2 Analyze data against acceptance criteria and specifications.
4.7 Reporting:
4.7.1 Prepare a Water Absorption Testing Report summarizing test procedures, results, and conclusions.
4.7.2 Include any corrective actions or recommendations based on water absorption testing findings.
4.7.3 Submit the report to QA for review and approval and maintain records as per facility procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Water Absorption Testing Report
Sample Testing Records
7) Reference, if any
USP (insert appropriate reference for dressings)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0