Ensuring Medical Device Quality: Field Test of High‑Purity Homogenization of Two‑Component Silicone with White Masterbatch
In medical device manufacturing, two‑component medical silicone can be called a "golden material"—it has excellent biocompatibility, temperature and ageing resistance, flexibility, and strong physiological inertness. It is widely used in catheters, sealing rings, face masks, balloons, laryngeal masks, negative‑pressure drainage bulbs, and even blood circuit tubing, respiratory tubing, and implantable‑grade components.
With the ageing population and rising surgical volumes, the global medical silicone market is expanding rapidly, and white masterbatch, as the mainstream auxiliary material for standardised colour control, has become almost a "standard feature" on every medical silicone production line.
Although two‑component silicone has broad application prospects in the medical device field, it still faces many technical challenges during actual production and processing:
- Uneven mixing, colour difference and local curing abnormalities: Agglomeration of white masterbatch and uneven dispersion of A/B components directly lead to colour deviations, insufficient sealing performance and mechanical properties, making leakage and detachment prone during clinical use.
- Residual bubbles, risk of microbial growth: High‑viscosity silicone easily entraps air during stirring, and the traditional step‑by‑step process of "mix first, deaerate later" introduces air again. Internal pores in the finished product become breeding grounds for microorganisms, reduce strength, and make sterile validation difficult to pass.
- Cleanliness and impurity control: Medical silicone must meet ISO 10993 biocompatibility standards. Paddle‑type stirring causes friction between the blades and the barrel wall, generating metal debris. Excessive impurities lead to ISO 10993 test failure and entire batch rejection.
- Process consistency and traceability: Without digital control, rotational speed and time rely entirely on manual experience, resulting in large batch‑to‑batch deviations and no data traceability, which poses high risks during regulatory inspections.
- Uncontrolled temperature rise, premature crosslinking: Two‑component silicone starts crosslinking rapidly after mixing. Conventional prolonged stirring generates frictional heat, easily causing premature material curing and narrowing the compression moulding operating window.
Solution
A domestic medical device manufacturer encountered the same difficulties when developing two‑component silicone products. Traditional paddle‑type mixers could not meet the high‑purity and high‑uniformity requirements for medical grade.
To address this, we used the ZYMC‑350VS non‑contact material homogeniser to carry out mixing and deaeration experiments on the material, and observed the results with a microscope.
Experimental Process
Client: A domestic medical device manufacturer
Test materials: Two‑component silicone and white masterbatch
Test equipment: ZYMC‑350VS non‑contact material homogeniser + microscope
ZYE Technology non‑contact material homogeniser ZYMC‑350VS
Objective: The material is completely mixed uniformly and consistently without bubbles, and the product can cure normally.
Experimental steps:
1.Weigh components A, B and white masterbatch according to the ratio, as shown below：
2.Use the ZYMC‑350VS for mixing and homogenisation
Test parameters as follows:
Mixing stage: speed 2000 rpm, time 60 s, ratio 50%, mode acceleration, initial temperature 25°C, end temperature 32°C.
Deaeration stage (multi‑stage mode):
- First stage: speed 100 rpm, time 90 s, ratio 100%, mode standard, initial temperature 32°C
- Second stage: speed 2000 rpm, time 60 s, ratio 50%, mode acceleration, end temperature 33°C
Effect after mixing and deaeration by the ZYE homogeniser
3.Sampling and preparation for observation: after mixing, take samples from three locations, prepare slides and observe the mixing condition, as shown below
4.Dispersion uniformity test: after mixing, take samples from three locations; from each sample, randomly select three points for observation. All three groups show no obvious agglomeration, and the material is uniformly dispersed.
5.Curing and section observation: place the samples in an oven at 120°C for one hour, then perform sectioning, and observe the dispersion effect at different positions in both horizontal and vertical sections under a microscope.
Observation of cured sample under microscope after sectioning
Observation results at different positions in horizontal and vertical sections
Results analysis
- Microscopic analysis of samples taken after mixing shows that the material is uniformly dispersed, with no agglomeration and no bubbles.
- The product can cure normally, with components A and B evenly distributed.
- After curing and sectioning, microscopic observation shows that the material remains uniformly dispersed at different positions in both horizontal and vertical sections.
The ZYMC‑350VS non‑contact homogeniser successfully achieved efficient mixing and deaeration of the two‑component silicone with white masterbatch. The material is uniformly dispersed with no residual bubbles, and the cured product performance meets the requirements for medical device applications.
Process advantages
- No blades, no contamination: Throughout the whole process, only the mixing cup contacts the material, eliminating metal debris and impurities, fully meeting the strict requirements for cleanliness, purity and low damage in medical silicone.
- Mixing + vacuum deaeration completed simultaneously: Greatly improves production efficiency and avoids the secondary air entrapment that can occur in the traditional process of mixing first and deaerating later.
- Dead‑zone‑free microscopic dispersion: The compound motion of revolution and rotation creates no mixing dead zones. Components A and B are uniformly dispersed at the microscopic level, so there is no local under‑curing or over‑crosslinking.
- Digital parameters, one‑click recall: All parameters—revolution/rotation speeds, vacuum level, mixing time, etc.—are digitally stored. Recipes can be recalled with one click, minimising human operational errors.
- Temperature rise controlled to ≤8°C: The entire mixing and deaeration process rises from 25°C to only 33°C, effectively preserving material activity, extending the operating window, and ensuring final curing performance.
Application Prospects
Industry data forecasts that by 2032 the global medical silicone market will exceed US$5.8 billion, with China being one of the core markets in the Asia‑Pacific region. At the same time, three major upgrade waves are forcing process innovation, and this type of non‑contact homogenisation equipment will become a standard fixture in medical silicone factories:
- Regulatory standard upgrades: ISO 10993 imposes stricter requirements for cytotoxicity and other indicators, with overall higher thresholds for cleanliness and traceability.
- Product iteration upgrades: Medical silicone is extending into implantable devices, wearable medical devices, drug‑release systems, and 3D‑printed complex structures, driving ever‑higher demands for mixing uniformity and raw material purity.
- High‑end production capacity transfer: International chemical giants such as Wacker Chemie and DuPont continue to expand their presence in the domestic medical silicone sector. Domestic manufacturers urgently need to upgrade through high‑end process equipment to build differentiated competitive advantages.
Mixing and deaeration of two‑component silicone with white masterbatch may seem like a “small step”, but it is in fact a critical link that affects the yield, regulatory compliance, and clinical safety of medical silicone products.
This real‑world test using ZYE Technology’s ZYMC‑350VS non‑contact material homogeniser validates a feasible path: blade‑free, low temperature rise, one‑step completion, fully traceable from start to finish—this is not merely an improvement in equipment parameters, but also a microcosm of the upgrade of medical silicone production from experience‑driven to data‑driven processing.
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