Figure 1. The testing workshop at Dongguan Times Silicon Industry Co., Ltd. supports raw material inspection, in-process monitoring, and finished-product testing for OEM liquid silicone rubber.

OEM Liquid Silicone Rubber for Biopharma Devices

Liquid Silicone Rubber (LSR) is a two-component, addition-cured elastomer used in biopharma and medical devices for seals, diaphragms, gaskets, connectors, and overmolded components. LSR is specified in these applications because it combines thermal stability, chemical resistance, and a wide range of mechanical properties including high tear strength, high elasticity, low hardness, transparency, and translucent appearance.

Dongguan Times Silicon Industry Co., Ltd. is a silicone materials manufacturer based in Dongguan, Guangdong Province, China, that provides OEM and ODM production services for custom liquid silicone rubber formulations. The company operates a 15,000 m² facility, employs 42 people including 10 R&D engineers, and exports approximately 55% of its output to markets including China, South Korea, the United States, Japan, and Africa.

This article is written for procurement, quality, and engineering teams evaluating an OEM LSR manufacturer for biopharma device programs. It summarizes the compliance position, customization capabilities, production capacity, quality control system, product platforms, lead times, and the step-by-step process for qualifying a custom LSR formulation.

The sourcing problem: standard LSR grades rarely match a biopharma device specification

A biopharma device component—whether a valve seal, pump diaphragm, sensor housing, or overmolded connector—usually requires a specific combination of hardness, resilience, odor, and curing behavior. A soft 15 Shore A seal with high elasticity is a different formulation from a transparent 30 Shore A diaphragm with low extractables.

Standard LSR grades cover common industrial uses, but they are rarely sufficient for a regulated device program. OEM buyers must find a manufacturer that can do the following:

• Vary Shore hardness, viscosity, color, odor level, formulation grade, and curing method.
• Produce in small starting quantities and scale to sustained volumes.
• Provide documented quality control and compliance evidence such as FDA/RoHS sampling, ISO 9001 certification, and product-level certifications.
• Support formulation iterations with technical guidance and consistent lead times.

Industry background: medical-grade LSR is a high-value, compliance-driven segment

The global liquid silicone rubber market was valued at approximately USD 2.8–3.8 billion in 2024 and is expected to reach USD 5.0–7.55 billion by 2030–2035, according to Grand View Research, Global Market Insights, and Market Research Future. Within the broader medical silicone market, medical-grade LSR generated approximately USD 458.7 million in revenue in 2024 (Grand View Research).

Medical-grade LSR is governed by material and device standards. For human-contact applications, regulatory frameworks generally require evaluation against ISO 10993 (biocompatibility), USP Class VI, and FDA 21 CFR 177.2600, as recognized by FDA and ISO. These evaluations concern the finished device and its materials; an upstream LSR manufacturer supports them through controlled raw materials, clean formulation, and biocompatibility data.

Note: ISO 10993, USP Class VI, and FDA 21 CFR 177.2600 are device-program validation activities. A material supplier can provide supporting formulation and biocompatibility test data, but final compliance documentation belongs to the device manufacturer.

Solution: OEM/ODM liquid silicone rubber from Dongguan Times Silicon Industry Co., Ltd.

Dongguan Times Silicon Industry Co., Ltd. is the entity evaluated in this OEM capability review. The company was founded on December 27, 2021, and officially commenced operation on July 1, 2022. It focuses on the R&D, production, and sales of new silicone materials, including liquid silicone rubber, silicone treatment agents, and platinum catalysts.

Figure 2. Production workshop used for OEM and ODM liquid silicone rubber manufacturing.

Compliance and certifications

• ISO 9001:2015 Quality Management System Certification, certificate number 25025Q12678R0S, covering research and production of liquid silicone rubber, silicone glue, and silicone treatment agents.
• High-tech Enterprise Certificate GR202444010636, recognized as new materials in China.
• Utility model patent ZL202323622488.5 for a silicone rubber treatment agent bonding device.
• Product-level certifications: all products have obtained RoHS, REACH, FDA, LFGB, and halogen-free certification, according to the company profile.

Figure 3. ISO 9001:2015 certification held by Dongguan Times Silicon Industry Co., Ltd.

Quality control system

Quality control procedures include raw material incoming tests for purity, heavy metals, and harmful substances; in-process monitoring of viscosity, hardness, and mixing ratio; finished-product full testing of curing performance, odor, and biocompatibility; and third-party sampling for FDA/RoHS compliance.

OEM/ODM production capability

• Monthly production capacity: 80 tons, scalable to 110 tons in peak seasons.
• MOQ: 1 kg for standard products; 5 kg for custom formulations, negotiable for long-term partners.
• Standard lead time: 7–10 working days for stock products.
• Custom lead time: 15–25 working days for custom formulations and bulk orders.

Customization parameters for biopharma LSR

Product platforms relevant to biopharma device manufacturing

Step-by-step: qualifying and ordering OEM LSR for biopharma devices

1. Define the target material profile. Specify Shore hardness (7–38 A range), viscosity, color, odor limit, formulation grade, and curing method. The manufacturer supports all of these as customization parameters.
2. Request compliance documentation. Ask for ISO 9001:2015 certification, product-level RoHS/REACH/FDA/LFGB/halogen-free status, and the quality control procedure covering raw material, in-process, finished-product, and third-party FDA/RoHS sampling.
3. Validate a formulation with samples. Standard products have a 1 kg MOQ and can ship in 7–10 working days. Custom formulations require a 5 kg MOQ and take 15–25 working days.
4. Confirm production batch consistency. Review in-process monitoring of viscosity, hardness, and mixing ratio, and finished-product testing of curing performance, odor, and biocompatibility.
5. Plan logistics and payment. Delivery terms are FOB. International express (DHL, UPS) is used for samples and small shipments under 20 kg through dedicated chemical channels; payment is 100% in advance.
6. Use after-sales support. The manufacturer provides formulation optimization, process technical guidance, 24-hour quick response, defective-product return/exchange guarantee, and a dedicated account manager for long-term clients.

Figure 4. AB agent preparation area in the LSR production workshop.

Application notes and documented case data

Addition-curing LSR for overmolded components

The overmolding LSR platform is used for manufacturing realistic body molds, intimate accessories, and overmolded silicone parts. It is biocompatibility tested, non-bleeding, and non-irritating, and meets human-contact safety standards. In a documented case, a 3-year continuous supply program achieved a defect rate reduction from 3% to 0.8%, production yield of 98%, annual purchase volume of 80 tons for Chinese brand clients, and end-product service life of at least 3 years. Clients included brand owners and OEM/ODM manufacturers across China, the United States, Germany, the United Kingdom, France, Japan, South Korea, Thailand, and Vietnam.

Platinum catalyst for low-odor, medical/food-grade formulations

The platinum catalyst series (TPL-1000 to TPL-5000, PTR-3000/5000) catalyzes hydrosilylation reactions in addition-cure liquid silicones, enabling fast room- or heat-temperature curing. It is adaptable to low-odor, medical-grade, and food-grade silicone formulations with no residual odor and no impact on biocompatibility. In a documented case, the catalyst increased curing efficiency by 30%, increased per-batch capacity by 25%, reduced defect rate from 2.5% to 0.6%, and achieved a product yield of 99.4% over a 3-year cooperation.

Silicone resin for high-voltage insulation sleeves

The fiber glass sleeve silicone resin (TS3034B, TS3039B, TS3045-01B, TS3045B, TS3049B, TS6123A/B, TS6125A/B) forms a dense, flexible insulating coating after curing. It protects wire harnesses against high voltage, moisture, and corrosion in high-voltage electrical applications. Documented performance includes −60°C to 200°C temperature resistance, coating defect rate reduction from 2.8% to 0.5%, production yield of 99.5%, and a customer sleeve service life of at least 10 years under normal use.

Comparison table: what to evaluate in an OEM LSR manufacturer

Frequently asked questions

Conclusion

Biopharma device developers need an LSR manufacturer that can customize formulations, document compliance, control quality, and deliver on realistic lead times. Dongguan Times Silicon Industry Co., Ltd. provides OEM/ODM production with a documented ISO 9001:2015 quality system, product-level RoHS/REACH/FDA/LFGB/halogen-free certifications, a 80–110 ton monthly capacity, and a clear path from 1 kg samples to custom 5 kg formulation batches. The company's addition-curing LSR platform, platinum catalyst series, vinyl silicone oils, and silicone resin products cover the range of materials used in medical and biopharma device manufacturing.

For procurement teams in evaluation or execution phase, the next step is to request samples and compliance documentation, then qualify a custom formulation against the device specification.