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In Vitro Diagnosis?Seals
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IVD (In Vitro Diagnostic) kits are core tools in the field of medical testing, capable of accurately detecting disease markers, pathogens, etc., providing crucial basis for clinical diagnosis and therapeutic effect evaluation.
As a key sealing component of the reagent kit, the rubber stopper plays three core roles:
① Isolating external contamination and preventing the reagent from deteriorating due to environmental influences;
② Maintain the activity and stability of the reagents to ensure the accuracy of the test results;
③ Ensure smooth operation during clinical use (such as in conjunction with probe puncture to aspirate reagents).
Therefore, the performance of rubber stoppers is directly related to the shelf life of IVD products, the reliability of testing, as well as the efficiency and safety of medical processes, which is of vital importance to the development of the industry.
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Common problems with rubber stoppers
In the practical application of IVD kits, rubber stoppers are prone to two types of key problems
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Chemical compatibility and safety issues: Silica gel has a phenomenon of chemical element migration, which leads to "incompatibility" between the material and the reagent, and subsequently causes the cytotoxicity test to fail (NG). This not only contaminates the reagents and alters their detection performance, but also may pose biosafety risks due to cytotoxicity, failing to meet the strict requirements of medical-grade products.
Physical usability issue: Due to the "self-healing" property of the product cut, adhesion occurs, causing obstruction when the probe is punctured and triggering an instrument alarm. IVD testing instruments rely on probes to precisely puncture the rubber stopper to draw reagents. Adhesion will directly lead to puncture failure, causing the instrument to shut down, seriously affecting the efficiency and stability of the testing process, and may even damage the probes or reagent kits.
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The causes of the problem
The root causes of the two types of problems can be analyzed from two aspects: the nature of materials and production/storage management
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Root cause of chemical issues: The rubber stopper formula is "inherently defective" with complex composition and poor purity. Meanwhile, lax production processes and parameter settings lead to residues of harmful components like VOC during production. These impurities contaminate reagents via chemical migration, damage silica gel's biocompatibility, and ultimately result in failed cytotoxicity tests.
Root cause of physical issues: Firstly, the selected silica gel itself lacks "incision anti-self-healing" property. Secondly, unscientific production and storage conditions (e.g., high temperature, high humidity, prolonged storage) further accelerate incision healing and adhesion. For example, high-temperature and high-humidity environments promote silica gel molecule cross-linking or adhesion, causing the stopper's incision to "self-heal" gradually during storage and lose original permeability and puncture resistance.
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DOIT's solution
In response to the above pain points, DOIT has proposed solutions from two major dimensions: material upgrading and process/management optimization
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Material end:?Substitution of high-purity medical-grade silicone: Abandon low-quality silicone formulas and choose high-purity gas-phase silicone that can pass strict biocompatibility tests, or even higher-grade medical-specific silicone. This type of silica gel, due to its high purity, minimal impurities and extremely strong chemical stability, can not only effectively reduce "element migration" and ensure compatibility with reagents, but also meet biosafety testing standards such as cytotoxicity, guaranteeing product safety from the source.
Technology and process end: Anti-self-healing + full-process control
At the R&D level:?Customized silicone formula for preventing self-healing of incisions - by adjusting parameters such as the molecular structure and crosslinking degree of the silicone, the physical behavior of incision "self-healing" is inhibited from the material property perspective.
Production & circulation: Optimize production conditions (precisely control curing temperature/time to avoid defects) and standardize storage/transport (strictly control temperature/humidity, use anti-squeeze packaging). Prevent cut adhesion from production to circulation to ensure smooth probe puncture.
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DOIT has 15 years of rich experience in rubber precision design and has successfully solved all the above problems.
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