Disposable filtration systems usually consist of disposable components, such as capsule filters, sterile connectors, bags, and pipes or tubes. As an integrator of disposable systems, Alfa Chemistry can provide reliable verification assistance to users of disposable systems.
We have product knowledge and laboratory analysis expertise, and can complete verification projects for one-off systems of various sizes and structural materials. Our close ties with industry and regulatory agencies ensure that the latest verification methods that reflect the latest thinking are adopted to achieve effective and successful verification.
Our Approaches
We can analyze individual components or the entire one-time system. The model system is used to verify the analysis. The model system is composed of the same construction materials as the user system and is assembled when used in the process. If the actual system is sterilized by gamma rays before use, the test is performed on the irradiation system. In the case of extractables research, the model solvent method is used to select a suitable extraction solvent for analysis.
The verification services available for the one-time system include:
- Capsules
- System
- Bags
- Extractables
- Bacterial Challenge
- Compatibility
- Product Viability
- Product Wet Integrity Testing
- Compatibility
The physical and microbiological validation scope for one-time systems of our one-time systems is as follows:
- Integrity and microbial penetration test
To verify the integrity, we provide physical and microbiological tests for disposable systems.
- Chemical compatibility test
Our experts perform mechanical tests to determine the chemical compatibility status between Sartorius disposable systems and customer solutions after storage to ensure process safety.
- Transport testing
We perform shipping tests in accordance with international standards to verify the integrity of single-use systems used to transport intermediate products.
- Pharmacopoeia testing
In order to check the quality of the raw materials used, we conduct chemical and biocompatibility tests on any components.
What We Offer
Verification Package
The verification package will be customized according to the customer’s specific needs and will include some or all of the following evaluations, depending on the one-time components being tested:
- Contamination test
- Bacteria challenge
- Compatibility assessment
- Extractables analysis
- Product wet integrity test
Before any testing begins, an agreement detailing the testing methods and acceptance criteria will be submitted for approval. After the test is completed, a comprehensive report containing all experimental data will be provided.
An Example of the Final Report
- Introduction: Project overview and project goals
- Summary: Description of general experimental methods
- Method: A description of the specific technology used
- Result: Detailed data sheet with data explanation as required
- Discussion: Data analysis and conclusions of each test
- Appendix: Detailed test method
Where possible, we will provide a fixed price for the project in advance. If this is not possible, we will provide estimates to help you budget and control costs. The final invoice will provide detailed information about items such as labor and materials. Please contact us for more service information.