The functional test of the Media Fill process is a critical validation step in pharmaceutical manufacturing, ensuring that the process operates correctly to maintain sterility and product integrity. This document outlines the purpose, required documentation, instrumentation, implementation steps, acceptance criteria, and results of the functional test. By following a systematic approach, this test confirms the reliability and compliance of the Media Fill process, thereby safeguarding quality standards.
Functional test of the Media fill process
Purpose: The purpose of this is to check the correct function of the media fill process. The line “Functional test of the media fill process,” followed by the statement of purpose, means the following:
Explanation:
Functional Test of the Media Fill Process:
This refers to a validation procedure conducted to ensure that the Media Fill process operates as intended.
- The media fill process is a crucial quality control step in pharmaceutical manufacturing that simulates the sterile filling process using a nutrient-rich media instead of the actual product.
- It helps confirm that the system and environment are free from contamination, ensuring the sterility of the manufacturing process.
Purpose of the Test
- The primary purpose of the test is to verify that all components, systems, and procedures involved in the media fill process are functioning correctly.
- This includes checking the equipment (e.g., valves, motors, heating elements) and control systems (e.g., SCADA) to ensure they operate per the predefined process flow and acceptance criteria.
- A correctly functioning Media Fill process ensures compliance with regulatory standards, product sterility, and overall process reliability.
Importance:
This validation is essential for identifying potential failures or deviations in the process before it is used for actual production. It confirms the readiness and reliability of the system to handle sterile operations in a real-world scenario.
In summary, this statement emphasizes the role of the functional test in ensuring the accuracy, reliability, and sterility compliance of the Media Fill process in pharmaceutical manufacturing.
Test document:
| Document name:
|
Document Number
|
version number | Number of pages:
|
| List of parameter | Media1982-001A-1 | 01 | 25 |
| Media fill chart | MD1982MF | 01 | 25 |
| Batch report | NA | NA | 25 |
| Functional specification | FS1982-1E | 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 |
| Media fill | 00 | 01 | 09/12/2024
08/06/2025 |
Acceptance criteria: Correct function of the Media fill test process according to media fill 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
Verification of the Media fill process
The verification of the media fill process takes place in accordance with the test document Media1982-001A-1 and the related chart of the media fill chart (MD1982MF). And inter the general parameter and media fill parameter, which are described in documents XYZMD1982MF, 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 | Test result (Pass/Fail) | Implemented (Date/sign) |
| Correct state of the documents (Valve, motors and heating elements) during the whole media fill process of running according to the media fill pin chart |
Pass |
Xyz09/12/2024 |
This section of the document records the outcomes of the functional test of the Media Fill process and serves as formal evidence of test completion, validation, and review. Here’s an explanation of its components
Test result:
Done by
| Test result pass/fail | Done by (signature and date ) |
| Pass | 09/12/2024 xyz |
1. Test Result (done by)
This entry identifies the individual responsible for executing the test. It includes:
- Test result pass/fail: Indicates whether the functional test met the predefined acceptance criteria (“Pass” or “Fail”).
- Signature and date: The tester’s signature and the date of test completion, ensuring accountability and traceability.
For example:
- Test Result: Pass
- Done by: Signature and date of the tester (e.g., 09/12/2024, xyz).
Test result checked by
| Test result pass/fail | checked by (signature and date ) |
| Pass | 09/12/2024 xyz |
2. Test Result Checked by
This section provides a second layer of validation. It confirms that the test results were reviewed and verified by a qualified individual, ensuring accuracy and compliance with protocols. It includes:
- Test result pass/fail: Confirms whether the result aligns with acceptance criteria.
- Checked by (signature and date): signature and date of the reviewer, affirming their responsibility for verification.
For example:
- Test Result Checked by: Pass
- Checked by: signature and date of the reviewer (e.g., 09/12/2024, xyz).
Purpose of This Section:
- Accountability: Ensures that both the tester and reviewer are identifiable and have taken responsibility for their roles.
- Traceability: Provides clear documentation of when the test was performed and verified.
- Compliance: Demonstrates adherence to regulatory and quality assurance standards by including signatures and dates.
This structured approach ensures transparency, reduces errors, and builds confidence in the validity of the Media Fill process functional test.
Summary
The functional test of the Media Fill process is conducted to validate its operational correctness as per predefined charts and documentation. Essential documents, including media fill charts and batch reports, are verified along with auxiliary equipment calibration. The freeze-drying unit must be operational, and the SCADA system must display no error messages that could impact the process. The test involves a detailed verification of components like valves, motors, and heating elements against the pin chart and SCADA data. All documents and reports are compiled, reviewed, and stamped as qualification documents. The process concludes when all acceptance criteria are met, and the results are recorded as “pass” or “fail.”
Conclusion
The functional test of the media fill process was successfully conducted, validating that the process operates according to the media fill chart. All acceptance criteria, including the correct state of components and compliance with SCADA system data, were met without deviations. This confirms the process’s readiness for production under stringent quality standards. The results, reviewed and verified, demonstrate the reliability and functionality of the media fill process.
FAQs
1. What is the purpose of the Media Fill functional test?
The purpose is to validate the correct functioning of the Media Fill process and ensure compliance with operational requirements to maintain sterility.
2. What documents are required for the Media Fill functional test?
Key documents include the Media Fill chart (MD1982MF), batch reports, and the functional specification (FS1982-1E).
3. What are the acceptance criteria for this test?
All components, such as valves, motors, and heating elements, must function correctly as per the pin chart and SCADA system data.