Compared with the traditional stainless steel system, single-use system has many advantages, such as: quick facility design and construction, eliminate cleaning and associated validation, small footprint (reduced number of supporting clean facilities), low cost, fully closed process, ready-to-use and high flexibility.
Since most single-use system will directly contact with the process fluid, the key components are considered as high-risk source, include single-use bags, tubing, connectors, filters. Risk assessment and corresponding research and verification work are required to confirm the impact of single-use systems on the quality, efficacy and safety of drug products.
Shanghai Duoning Biotechnology Co., Ltd. and CTI Testing and Certification Group Co., Ltd. have brought together senior teams from both parties to establish a single-use system testing and validation platform, which will focus on quality inspection and product verification of single-use systems, including extractables and leachables research, microbial testing, filter integrity and virus removal.
Services areas
Extractables/Leachables
Extractables: Chemicals that can be extracted from process fluid contact surfaces of single-use system component materials under worst-case conditions (such as organic solvents, extreme heat, high ionic strength, pH, contact time, etc.). Extractables represent the greatest potential for substances to migrate into the product.
Leachables: Chemicals that migrate from product-contact or non-product-contact materials into drug product or process fluids under storage or normal process conditions. Leachables are usually a subset of extractables and may also include reaction or degradation products of extractables.
We will perform risk assessment based on customer-specific process, and implement customized validation services based on the assessment results. After collecting the data of extractables/leachables researches, experts will conduct strict judgments about whether extractables / leachables will affect drug quality and patient safety，combining information of actual production process and drug administration methods.
Chemical Compatibility Test
Confirm the integrity of single-use systems (single-use bags, tubing, filters, etc.) after contact with process fluids under specific conditions.
The specific test indicators are related to the type of single-use system, and are usually selected from the test indicators such as integrity, pressure resistance, weight, surface analysis, thickness, and tensile strength.
Bacterial retention test
Simulate the worst conditions in the actual filtration process, filter the product solution or product equivalent solution containing a certain amount of challenge microorganisms, and confirm the microbial retention capacity of the sterilizing filter.
Adsorption test
Confirm that the concentration or quality of the drug solution or solution components will not fail to meet stablished standards due to the adsorption of single-use system.
Single-use bags, tubing assemblies, and filters may all have adsorption risks, and the adsorption mechanisms may include ionic bonds, van der Waals forces, and hydrophobic interactions. In addition, factors such as solution composition, product concentration, contact time, and temperature may also affect the degree of adsorption. |
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