Silicone Injection Molding
ISO 13485 & ISO 9001 Quality Management System
SILIKON Technologies uses state-of-the-science, all electric silicone injection molding machines with servo-electric, 3-axis robotic part removal for uninterrupted manufacturing and the safest conditions for your investment in your tool and products. Our molding processes are scientifically developed and obsessively monitored . The systematic approach includes determination of fill, cavity-to-cavity balance, statistical analysis of both process parameters and product, process limit specification, process qualification, process validation and continuous process monitoring. We process LSR (Liquid Silicone Rubber) that is a two-part, platinum-catalyzed, heat-cured silicone elastomer. We are familiar with all the leading LSR manufacturers and have experience molding a vast range of silicone grades and durometers.
SILIKON Technologies’ Quality Management System (QMS) is registered to both ISO 13485 for medical customers with products requiring regulatory controls, and to ISO 9001 for non-medical customers that rely on our documented QMS to assure processes and products meet specified requirements.
Why use a medical grade silicone for your component’s manufacturing?
There are 12 different durometers to choose from: A, B, C, D, DO, E, M, O, OO, OOO, OOO-S & R. Not sure what durometer you need for your application? Not to worry, we can help you with that! We can also help you choose which grade of LSR (liquid silicone rubber) is best for your application.
- Electrically conductive (which is carbon-filled)
- Medical grade
- Self-adhesive
- Various combinations of the above
Silicone has actually been used in the medical industry for over 50 years, and is a very stable, chemically inert material with additional attributes such as:
- Withstands extreme flexing and still returns to its original state
- Has excellent resistance to chemical, oil, oxidation, light, UV rays & X-rays
- Meets FDA regulations for use in medical devices and with food contact; its properties are inherently inert to bacteria, mold and fungi.
- It can withstand extreme temperature ranges well beyond that of thermoplastic
- It is naturally transparent, odorless & tasteless but can be colored with non-hazardous pigments for color matching
- Has excellent dielectric properties for use with device electronics
- Has a superior gas permeability factor that’s approximately 400 times that of rubber, making it an exceptional choice for medical products that go through a sterilization or autoclaving process; in fact, medical grade silicone can be autoclaved with no effect to its physical properties
- Has better biocompatibility than a thermoplastic elastomer (TPE), and has no “extractables” if it is cross-linked
- Bonds best with polycarbonate (PC) and Nylon thermoplastics (but very poorly with polyethylene (PE) and polypropylene (PP); it can be overmolded onto metal components
- Does not become stiff or brittle over time, and has a very low aging level; it has superior elongation & tear resistance, making it an ideal material for gaskets and o-rings in medical devices
Scientific Processing Techniques
All of our processing decisions are backed by pure scientific data and years of expertise in precision, tight-tolerance molding so that we manufacture products right the first time, saving the customer time and money. Processing & SPC data is highly secure and consistently backed up, which allows us to maintain records that can prove at any point in time, what the condition and environment a product lot was manufactured in. This proactive approach keeps statistical job performance information available to us for immediate access anytime, anyplace.
Touch screen menus on the terminals at each press allow our technicians, processors and engineers to focus on the most critical specifications. Additional menus help to verify that the press #, tool #, part #’s, and purchase order details match the scheduled template loaded. Any shot that runs outside tightly established customer and SILIKON Technologies set parameters is automatically diverted from the production stream to a separate quarantine bin, ensuring that it never reaches the customer.
Engineering
Once a project engineer is assigned to your account they will work with you on every single product, from engineering assistance through full qualification/validation and approvals. Once a part is approved and is in regular production, your purchasing team can then coordinate with a customer service representative who will keep track of your product orders and deliverables. When you need to make changes to the design of a part or when you start working on next generation product designs, that same SILIKON engineer will work side-by-side with you until your product modification or new product launches successfully.
SILIKON Technologies is here to help you during every phase of your project. Our staff provides engineering, tooling, manufacturing, quality assurance, assembly and packaging assistance. This important step helps to keep your costs low, a mission as critical to SILIKON as it is to your own organization. Partnering with the right manufacturer early on will save you both time and money as your product goes from conception to full production. Our Engineers can help with modifications, next generation product enhancements and evaluation of the entire manufacturing process to determine where steps can be combined (either in your facility or within SILIKON Technologies) or even eliminated through lean cell manufacturing or advanced processing.
- Risk Management - DFMEA & PFMEA
- Validation Protocols
- Flow Analysis
- Statistical Analysis
- Color Matching
Tool Manufacturing & Support
With the support of our sister company (Polymer Conversions, Inc), SILIKON Technologies has the ability to provide in-depth support for your new tooling or existing tool transfer programs. All of our processes are fully documented through our strict procedures to provide our customers with peace of mind and the highest level of quality & precision, to make sure all projects transition smoothly into full production.
- Transfer Tooling
- Production or Prototype Tooling
- In-House Design and Manufacturing of fixtures
- PM schedules designed around tool life optimization
Value Added Services
- Assembly
- Joining
- Final packaging
