Standard Operating Procedure for Leak Testing of Cream Tubes and Containers
1) Purpose
The purpose of this SOP is to define procedures for conducting leak testing on tubes and containers used for creams. This ensures that packaging maintains integrity to prevent leakage, contamination, and ensure product stability throughout its shelf life.
2) Scope
This SOP applies to the Quality Control Department and personnel responsible for conducting leak testing of cream tubes and containers. It covers testing methods, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Control Manager is responsible for overseeing leak testing activities. The Quality Control Team and Packaging Operators are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Equipment Setup
4.1.1 Prepare the leak testing equipment (e.g., vacuum chamber, pressure gauge) according to manufacturer instructions.
4.1.2 Verify the calibration status of equipment before testing begins.
4.1.3 Ensure all necessary safety precautions are in place.
4.2 Sample Preparation
4.2.1 Select representative samples of cream tubes or containers from the batch for testing.
4.2.2 Label each sample with batch information and identification numbers.
4.2.3 Inspect samples visually for any defects or damage before testing.
4.3 Leak Testing Procedure
4.3.1 Place each cream tube or container into the leak testing equipment.
4.3.2 Apply the specified vacuum or pressure as per testing method requirements.
4.3.3 Monitor the equipment for the specified duration to detect any signs of leakage (e.g., pressure drop, bubble formation).
4.4 Acceptance Criteria
4.4.1 Determine acceptance criteria based on regulatory standards and product-specific requirements.
4.4.2 Assess each sample against the acceptance criteria to determine pass or fail status.
4.4.3 Record and document results for each tested sample.
4.5 Reporting
4.5.1 Prepare a leak testing report summarizing test methods, equipment used, results, and compliance status.
4.5.2 Include any deviations from acceptance criteria and corrective actions taken, if applicable.
4.5.3 Obtain approval from Quality Control Management for the leak testing report.
4.6 Retesting and Non-Conforming Samples
4.6.1 Retest samples that initially fail to meet acceptance criteria using the same or alternative testing methods.
4.6.2 Segregate and quarantine non-conforming samples to prevent unintended use.
4.6.3 Investigate root causes of non-conforming results and implement corrective actions to prevent recurrence.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
ISO: International Organization for Standardization
6) Documents, if any
Leak Testing Protocols
Leak Testing Reports
Non-Conforming Material Reports
Corrective Action Reports
7) Reference, if any
ISO
USP
8) SOP Version
Version 1.0