The Functional Test of the Filter Integrity Test (WIT) is a critical component in validating the performance of filters used in freeze-drying systems. This process ensures the correct operation of filters, enabling them to maintain sterility and reliability during production. By adhering to standardized protocols, this test evaluates filter performance against specific parameters and provides a comprehensive review of their integrity. This document outlines the test purpose, required documentation, parameters, instrumentation, acceptance criteria, and procedural guidelines necessary for ensuring compliance with operational and quality standards.
Purpose: the purpose of this to check the correct filter integrity test
The purpose section of this document outlines the main objective of performing the filter integrity test (WIT) in freeze-drying systems. Here’s a detailed explanation of its key points:
Key Points in the Purpose Section
- Ensures Filter Functionality
- The test is designed to verify that the filters are functioning correctly and maintaining integrity during the freeze-drying process.
- It helps ensure that no contaminants pass through the filter, safeguarding the sterility of the system.
- Maintains Product Quality
- By validating filter performance, this test ensures that the final product remains uncontaminated, meeting the required quality and regulatory standards.
- Compliance with Specifications
- The test ensures that the filter operates according to the parameters specified in the operational and functional documentation.
- This step is critical for adhering to quality assurance protocols and meeting regulatory compliance.
- Operational Readiness
- The test confirms that the filter system is ready for use in production without any operational issues.
- This reduces the likelihood of process interruptions caused by filter malfunctions.
- Supports System Validation
- The test is an integral part of the overall validation of the freeze-drying system, ensuring that every component is reliable and fit for its intended use.
By conducting this test, organizations can guarantee the proper functioning of filters, prevent failures, and maintain consistent operational performance. Let me know if you’d like further elaboration!
Test document:
|
Document name:
|
Document Number
|
Document version number |
Document number of page:
|
|
List of parameter |
XYZ01520-001B-1 |
00 |
25 |
|
Integrity test filter number |
PC1520-IT_1 |
01 |
25 |
|
Batch report |
NA |
NA |
25 |
|
Functional specification number |
FS1520-1E |
NA |
NA |
Remark: If column number of page is blank, the listed document, which contributed to the determination of the test result, must be attached to the qualification binder (Attachment number: 01 02, 03, etc.) And mark the test documents and report print out first page with “qualification documents” and stamp
Required instrumentation and auxiliary
|
Type of equipment |
Type model/version number |
Serial number |
Calibration done and calibration due date |
|
Filter integrity |
00 |
01 |
08/12/2024 07/06/2025 |
Acceptance criteria: Correct function of the filter integrity test process according to integrity test filter and chart
Implementation:
- The functional test is based on the process flow chart
- Possible instructions and note in the test documents are to be considered
- The freeze drying unit must be switched on, and all supply media must be connected and present.
- No failure messages, which have an impact on the implementation, are displayed on the SCADA system
- The tester must be appropriately assigned on the freeze drying unit and SCADA system
Variation of the filter integrity tester
The verification of the filter integrity test process takes place in accordance with the test document XYZ01520-001B-1 and the related chart of the filter integrity chart (DC1520IT_1). And inter the general parameter and integrity test parameter, which are described in documents XYZ01520-001B-1, and start the process.
Compare the state of components (valve, motors, and heating elements) on the pin chart. The pin chart with the displayed state of documents on the SCADA system.
Ticks of all checked states of documents on the pin charts. The pin chart and batch report have to be attached to this OQ documents after testing
Acceptance criteria:
|
Acceptance criteria |
Test result Pass/Fail |
Implemented (Date/sign) |
|
Correct state of the documents (Valve, motors and heating elements) during the whole integrity test process of filter run according to the pin chart |
Pass |
Xyz 08/12/2024
|
Test result:
Done by
|
Test result pass/fail |
Done by (signaturenature and date ) |
|
Pass |
08/12/2024 xyz |
Test result checked by
|
Test result pass/fail |
checked by (signaturenature and date ) |
|
Pass |
08/12/2024 xyz |
This table records the results of the functional test for the filter integrity test (WIT) and provides traceability by including information about the personnel involved in conducting and verifying the test. Here’s a detailed explanation of the table:
Columns and Explanation
- Done by
- It indicates the person who conducted the test.
- The corresponding signature and date are provided to ensure accountability and traceability.
- Test result pass/fail
- Documents whether the test passed or failed.
- In this case, the result is marked as “Pass,” signifying that the test met the required acceptance criteria.
- Test result checked by
- Refers to the person responsible for reviewing and verifying the test results.
- This ensures that the testing process and results are validated by another qualified individual.
- Checked by (signature and date)
- The signature and date of the reviewer are included for authentication.
Table Values
- Test Performed by: The test was conducted by the individual “xyz” on 08/12/2024, and the results were marked as Pass.
- Test Verified by: The same individual, “xyz,” reviewed and verified the results on the same date, 08/12/2024, and confirmed the results as Pass.
Purpose of the Table
- Ensures traceability by identifying who performed and reviewed the test.
- Provides accountability and compliance with quality assurance standards.
- Confirms the acceptance of test results in alignment with predefined criteria.
This structure is common in qualification and validation documentation to meet regulatory and procedural requirements.
Conclusion
The Functional Test of the Filter Integrity Test (WIT) successfully verifies the operational performance of the filter integrity testing process, ensuring compliance with predefined parameters and documentation standards. The test demonstrates the system’s ability to maintain the correct functioning of valves, motors, and heating elements in alignment with the pin chart and SCADA system data. Proper implementation of this test supports the reliability of freeze-drying processes, minimizing risks associated with filter failure. All testing records, batch reports, and associated documentation are to be retained as part of the qualification binder for future audits and reviews.
Summary
The Functional Test of the Filter Integrity Test (WIT) This test follows a structured methodology using predefined documentation (e.g., XYZ01520-001B-1), pin charts, and SCADA system data. Parameters such as valve states, motor functions, and heating elements are cross-referenced with the pin chart. The freeze-drying unit and all auxiliary systems must be operational, with no SCADA failure messages impacting the process. Test results are documented with the signatures of the responsible personnel, ensuring traceability and compliance. Adherence to acceptance criteria guarantees the system’s reliability and operational readiness.
FAQs
Q1: What is the purpose of the WIT filter integrity test?
The WIT filter integrity test ensures that filters used in freeze-drying systems are functioning correctly, maintaining sterility, and meeting operational standards.
Q2: What documentation is required for the test?
Key documents include the test document (e.g., XYZ01520-001B-1), pin charts, and the batch report. All documents contributing to the test results must be attached to the qualification binder. And marked as “qualification documents.”
Q3: What equipment is needed for the test?
The required equipment includes a filter integrity tester and any auxiliary devices specified in the documentation. Details such as model numbers, serial numbers, and calibration records must be provided.
Q4: What are the acceptance criteria for the test?
The test must confirm the correct functioning of filters during the entire process, as outlined in the pin chart. All valves, motors, and heating elements must operate correctly, with results documented as pass or fail.