Single-use filtration systems typically consist of disposable components such as capsule filters, sterile connectors, bags and piping or tubing. As an integrator of single-use systems, Pall can provide reliable validation assistance to the users of single-use systems. Pall has the product knowledge and laboratory analytical expertise to complete validation projects for single-use systems of a wide range of sizes and materials of construction. Pall's close link with industry and regulatory agencies ensures an up-to-date validation approach reflecting the latest thinking, thus achieving an effective and successful validation.
Single-Use Systems Validation ApproachesAnalytical work can be performed for individual components or to the entire single-use system. A model system is used for the validation analysis. This model system is composed of the same materials of construction as those of the user system and is assembled as it is used in process. If the actual system is sterilized by gamma-irradiation before use, then the test is performed on an irradiated system.
In the case of extractables study, a model solvent approach is used to select a suitable extracting solvent for analysis. For example, worst-case solvents can be selected to represent a range of buffers with varying pH values. For applications that involve a filter attached to a bag or a filter attached to a bag with an sterile connector, the model solvent is filtered into the bag according to the specific process steps and then stored for the appropriate period. |
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Typical models for buffer solutions include: water for injection (WFI), pH adjusted to > 9, < 9, and WFI at neutral pH (5 – 7). A similar approach can be used for media and for product.
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Available Single-Use Systems Validation Services
- Bacterial Challenge
- Bags
- Capsules
- Compatibility
- Extractables
- Kleenpak Sterile Connector
- Product Viability
- Product Wet Integrity Testing
- System
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Single-Use Filter Validation Package
The validation package will be tailored to meet the client's specific needs and will include some or all of the following evaluations, depending on the single-use components being tested:
- Bacterial Challenge
- Compatibility Assessment
- Extractables Analysis
- Soiling Test
- Product wet integrity testing
Prior to the start of any test, a protocol detailing the test methodology and acceptance criteria will be submitted for approval. Upon completion of testing, a comprehensive report including all experimental data will be provided.
An Example of the Final Report
- Introduction: An overview of the project and objectives of the project.
- Summary: A description of the general experimental approach.
- Methods: A description of the specific techniques used.
- Results: Detailed data tables with explanations of data, as needed.
- Discussion: An analysis of the data with conclusion for each test.
- Appendices: Detailed explanation of test methods.
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Ordering Information
Charges
Wherever possible, we provide a fixed price in advance for the project. Where this is not possible, we will give an estimate to assist you in budgeting and cost control. The final invoice gives details on items such as labor, and materials.
What's the Next Step?
Contact your local Pall representative. They will discuss your specific requirements with you and forward your enquiry to Pall Validation Services Teams. We recommend you do this well in advance of a regulatory audit to ensure there is adequate time to generate appropriate test data.
Ordering Information
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