Manufacturing drug delivery devices is a high-stakes operation. Components must perform flawlessly and prevent contamination. SIMTEC Silicone Parts is your reliable partner for Liquid Silicone Rubber (LSR) drug-delivery parts.
We have extensive experience in medical device manufacturing, eliminating batch-to-batch variability with a stable process, and precision accuracy with our automated molding. We also maintain the strict regulatory compliance you need, while handling complex specifications.
Meeting Strict Requirements for Medical-Grade LSR
At SIMTEC, we manufacture silicone components used in a variety of drug-delivery systems. Applications include syringes, IVs, autoinjectors and biocompatible LSR seals for wearable insulin pumps. We select biocompatible medical-grade LSR, sourced from leading international silicone suppliers.
The LSR materials we use offer advantages like:
- FDA biocompatibility
- Hypoallergenic
- Chemical and bacterial resistance
- Low compression set
These silicone elastomers are biocompatible and nontoxic, making them safe for patient contact, interaction with bodily fluids, and the medication’s pathway. Chemical resistance prevents degradation when exposed to active pharmaceutical ingredients, chemotherapy drugs, or insulin over long periods. Bacterial resistance maintains a sterile fluid path to protect patient health, while low compression set properties keep essential components resilient and retain sealing properties throughout the device’s shelf life.
LSR’s benefits also support other applications. Elongation allows pump diaphragms and membranes to stretch repeatedly and maintain their shape. Tear strength prevents the septa from tearing or coring when users pierce them to draw or deliver medicine.
Precision Engineering for LSR Drug Delivery Components
SIMTEC manufactures a full spectrum of LSR components used in drug delivery products, including:
- Septa
- Valves
- Duckbill valves
- Membranes
- Diaphragms
- Plunger plugs/tips
- Canula plugs
We offer high-volume production with consistent manufacturing. The advanced technology in our processes enhance device efficacy and patient safety — a fully automated, hands-free injection molding process eliminates batch-to-batch variability and contamination risks from operators. This level of precision engineering is especially crucial for fluid-path components, where a single micro-defect could lead to leaks or dosage errors.
SIMTEC has the expertise to manufacture liquid silicone rubber components for autoinjectors, complex fluid-management systems, and syringes. We also offer complete vertical integration, including post molding, secondary operations, like slitting, laser marking, and packaging, performed robotically in line, immediately after the parts leave the molding machine.
Our highly customized production and tailored QA processes enable us to consistently manufacture the exact part you need – from the first parts to the last. Plus, we maintain the required level of quality for even the most critical components.
ISO 13485 Certified LSR Manufacturing Capabilities
Our quality management system (QMS) sets a high standard for our operations and has maintained our ISO 13485 certification status for many years. These procedures are necessary for the manufacture, handling, and delivery of components used by medical and healthcare product manufacturers for drug delivery, surgical and medtech devices.
The ISO certification applies to all of our LSR, LSR multi-shot, and LSR overmolding manufacturing cells. Whether combining rigid plastic and flexible silicone materials in a single 2k molding process, or producing tiny micro-sized parts and tight tolerance components – we maintain the specifications and quality you need. In fact, we are proud to have one of the lowest defect rates in our industry.
For medical silicone parts with specific hygienic requirements, we have an ISO Class 8 clean room preventing contamination during the molding process. These specially designed controlled environments reduce particles and control contaminants from entering during manufacturing and coming into contact with the parts.
Partner with SIMTEC for High-Volume LSR Production
We can meet your exact design specifications for LSR drug delivery components. Choose us for uncompromising quality and high-volume manufacturing partnerships. Contact us online or call 954-278-3572 to discuss your project.