Disposable filtration systems typically consist of disposable components such as capsule filters, aseptic connectors, bags and piping or tubing. As an integrator of disposable systems, Pall can provide reliable validation assistance to the users of disposable systems. Pall has the product knowledge and laboratory analytical expertise to complete validation projects for disposable 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.
Approaches
Analytical work can be performed for individual components or to the entire disposable 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 aseptic connector, the model solvent is filtered into the bag according to the specific process steps and then stored for the appropriate period. 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.Validation Services Available to a Disposable System
- Capsules
- Bacterial Challenge
- Compatibility
- Product Viability
- Product Wet Integrity Testing
- System
- Extractables
- Bags
- Extractables
- Compatibility
- Kleenpak Connector
- Extractables
- Compatibility
Case Study:
Extractables analysis for disposable bags
Pall can perform analyses and provide comprehensive reports on the quantification and identification of extractable materials from a disposable system. The type and the amount of extractable material found following storage of filled bags is typically included in these studies. The tests are done for real time storage, with interim tests performed for disposable systems that are stored for extended periods of time. An appropriate storage temperature is used throughout the storage period. A number of analytical methods can be used to analyze the fluid after extraction. The selection of methods will depend on the requirements of the application. Examples of methods include:- GC-MS or LC-MS
- Total Organic Carbon (TOC)
- Particulate analysis
- pH
- Conductivity
The 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 disposable components being tested:- Compatibility Assessment
- Extractables Analysis
- Soiling Test
- Bacterial Challenge
- Product wet integrity testing
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
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.Services
Testing
| Test Services | Test Requirements | Part Numbers |
| Capsules | Microbial Retention | PTS01BA (Basic) |
| PTS01BB (Mid) | ||
| PTS01BC (Complex) | ||
| PTS01BD (Cartridge challenge studies) | ||
| PTS01BE (Process specific bacteria) | ||
| PTS01BF (Cytotoxics) | ||
| Compatibility | PTS01CA (Basic) | |
| PTS01CB (Complex) | ||
| Product Viability | PTS01VA (Basic) | |
| PTS01VD (Process specific) | ||
| PTS01VE (Cytotoxics) | ||
| Product-wet Integrity Test | PTS01PA (One pressure source) | |
| Parameters | PTS01PB (Two pressure sources) | |
| PTS01PC (Cytotoxics) | ||
| Extractables | PTS01EA (Generic) | |
| PTS01EB (Lab tests) | ||
| PTS01EC (Complex tests) | ||
| Disposable Bags | Extractables | PTS01EH |
| Compatibility | PTS01CF | |
| Kleenpak Connectors | Extractables | PTS01EJ |
| Compatibility | PTS01CG | |
| Soiling tests | PTS01SA (Fluid specific) | |
| PTS01SB (Organism specific) | ||
| PTS01SC (Full process specific) | ||
| System | Extractables | PTS01EK |
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