Services

Services

Custom Compounding

Compounding Solutions offers superior quality custom compounding of a vast range of thermoplastic polymers in a multitude of applications that most people are unaware of them in their everyday life. Let Compounding Solutions partner with your engineers from the beginning of your application to help identify the proper resin, additive, modifier, filler, and colors necessary to formulate a custom compound for your individual needs.

Applications:
     > Custom Color
     > Heat and UV Stabilization
     > Flame Retardant
     > Glass or Carbon Reinforced
     > Mineral Reinforced
     > Heavy Metals: Steel, Tungsten
     > Radiopaque
          >> Barium Sulfate
          >> Bismuths
          >> Tungsten
          >> Boost RO & RO+
     > Nano-technology
          >> Clays
          >> Carbons
     > Processing Aids / Lubricated
          >> Mobilize
     > Anti-Microbial
          >> Silver & Copper Based

Thermoplastics Processing Capabilities:
     > Polyolefins: LLDPE, LDPE, HDPE, PP
     > Styrenics: CPS, HIPS, SBC, SAN, ABS, FR ABS, ASA
     > PolyAcetals: POM
     > Polyesters: PET, PBT
     > Polycarbonates
     > PolyAmides: 6, 6/6, 6/10, 11, 12, 6/12
     > High Heat Resins: PEI, PSU, PES, PEEK, LCP
     > PolyUrethanes
     > Biodegradable: PLA, PLLA
     > Fluoropolymers: PVDF, FEP, PFA, ETFE, EFEP
     > Thermoplastic Elastomers: Hytrel, Pebax

Customizable Properties
     > Optimized Mechanical Properties
          >> Strength, Stiffness, Hardness, Flexibility
     > Electrical & Thermal Conductivity
     > Lubricious Surface
     > Flame Retardants
     > Gas & Vapor barrier
     > Abrasion Resistance
     > Chemical Resistance
     > Overmolding / Bondability


Medical Compounding

Lifesaving and life extending technologies are evolving around the world.  The base materials used in the production of such devices are often overlooked and taken for granted despite being the backbone of the technology.  Many times, engineering decisions are made based on previous personal history with any given material be it Nylon or PTFE or HDPE.  The limitations of the base materials are often understood but the ability to customize those properties is not.  On many occasions project teams choose previously used, well-known materials, however via a short conversation with Compounding Solutions your eyes can be opened up to so much more!  Tens of thousands of unique materials exist, each of which can be compounded to modify its properties.  Hard or soft, compliant or rigid, clear or colored, lubricious or tacky qualities can all be imparted via a huge range of additives.

A quality that nearly all device companies search for is a USP VI or ISO 10993 certification on the materials.  Generally, this approach is followed because it is thought that this will lead to an FDA approval based on that rating.  Anything but that is the case.  FDA device review is done as an agglomeration rather than piecemeal.  While the constituents may be USP VI the entire device is not.  An overloading within the assembly of any given component can push cytotoxicity levels over acceptable limits.

Compounding Solutions stays very close to the medical device industry working with our customers from the R&D process through the final FDA reviews and market launch.  Throughout this process, we focus on the feedback the reviewers are passing along.  With this knowledge, we can help guide you to select the most appropriate components for your custom compound.

Compounding Solution’s compounding process is done in our controlled environment production area (White room) which ensures that all our medical grade polymers and compounds will be made with the highest quality and purity in mind.  It is designed to minimize exposure to airborne particulates, common contaminates, and moisture.  Beginning in October 2011, manufacturing of our medical grade compounds was transferred to our “White Room” compounding area.  Responding to the needs of our customers as well as industry demands for cleaner manufacturing environments, we set out to complete a massive facility expansion centered on a new manufacturing area meeting the needs of the medical compounding market.

Our “White Room” is the largest production facility of its kind.  To ensure a clean environment, the “White Room” includes an Air Lock with a positive pressure environment, sealed and polished concrete floors, HEPA filtered air exchange with humidity and temperature controls, and epoxy coated wall surfaces to repel dust and allow for easy cleaning of all surfaces.  Great care was taken in designing our “White Room” to minimize all potential sources of product contamination.  From point of use dust collectors, to underground energy sources, we have ensured that every compound manufactured in our “White Room” will be of the highest quality and purity.


Toll Compounding

Compounding Solutions offers toll compounding services that allow our customers to supply the raw materials and specify formulas. We then supply the compounding experience and knowledge to ensure the same top-notch quality that we expect all of our own products to have. Your toll compounding products are treated with the same care and are subjected to the same rigorous quality testing as our own custom compounded products.

Our equipment allows for maximum quality and consistency from lot to lot and pellet to pellet with the use of:

> Dehumidifying dryers.
> Nitrogen blanketed loss in weight feeders for both pellet and powder.
> Strand or underwater pelletization to allow for the best pellet quality based on the material being compounded.
> Tumblers allow for post-blending to achieve consistent final product prior to packaging and shipping.

Our compound testing capabilities include melt flow, viscosity, density, ash content, hardness (shore A or shore D), tensile, elongation, along with a multitude of others.


R&D Services

Compounding Solutions newly expanded research and development capabilities with the creation of the Pete Goguen Innovation center. This 2000-square foot center has allowed the Compounding Solutions R&D team to increase productivity by taking the R&D process out of the day to day productions. The center includes:
     > Production size twin screw compounding line
     > Lab Scale twin screw compounding line
     > Single screw extruder
          >> Compounding developments
          >> Films
     > 3 Injection molders
     > Two roll mill
     > Dryers & Ovens
     > Annealing, crystallizing, and solid state polymerization.

Our sophisticated on-site laboratory and development equipment enables us to offer the opportunity for our customers to team up with our R&D engineers and material specialists to develop and manufacturer your custom material. Our 8 person R&D department is a multi-disciplinary team with bachelor and master degrees in fields of Chemical Engineering, Materials Engineering, Plastic Engineering, Mechanical Engineering, Computer Engineering, Health Physics, Extrusion Engineering and Color Science.

This “hands-on” approach allows our customers to make on-line modifications to the process and material characteristics, greatly decreasing development costs and time-to-market. Compounding Solutions’ modern facility was designed specifically to streamline compounding operations in a clean& controlled environment.


Quality Testing

Compounding Solutions has the testing capabilities needed to ensure our products are of the highest quality and meet all required specifications. The range of available testing is very extensive, from the basics of color and moisture content to the material identification of FTIR testing and everything in between.

Mechanical

     > Tensile Strength, Modulus, Elongation: ASTM D638 & ASTM D412 – Standard Test Method for Tensile Properties of Plastics
     > Flexural Strength and Modulus: ASTM D790 – Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
     > Deflection: ASTM D790 – Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

Physical

     > Density: Pycnometer ASTM D6226
     > Ash Content: ASTM D5630-06 – Standard Test Method for Ignition Loss of Cured Reinforced Resins
     > Hardness: ASTM D2240 – Standard Test Method for Rubber Property – Durometer Hardness
     > FTIR: ASTM E168 – Standard Practices for General Techniques of Infrared Quantitative Analysis.
     > Compounding
          >> Pellet Porosity: Pycnometer
          >> Moisture Content: ASTM D6980 & ASTM D7191-10
          >> Dispersion

Impact

     > Notched Izod: ASTM D256 – Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
     > Unnotched Izod: Standard Test Method for Unnotched Cantilever Beam Impact Resistance of Plastics

Rheology

     > Melt Flow Index: ASTM D1238 – Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
     > Capillary Viscosity: ASTM D3835 – Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer

Visual

     > Yellowness Index: ASTM E313 – Standard Practice for Calculating Yellowness and Whiteness Indices from Instrumentally Measured Color Coordinates
     > Transmission (%): ASTM D1003 – Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
     > Haze (%): ASTM D1003 – Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics

Electrical

     > Surface Resistivity: ASTM D257 – Standard Test Methods for DC Resistance or Conductance of Insulating Materials
     > Volume Resistivity: ASTM D257 – Standard Test Methods for DC Resistance or Conductance of Insulating Materials


Material Sourcing

With a vast network of qualified suppliers and knowledgeable in-house staff, look to Compounding Solutions as a resource for your raw material needs. We stock and have quick access to a wide range of thermoplastics including both medical and non-medical grade resins, as well as a broad spectrum of additives, pigments, fillers, etc.

Challenge us with any request by utilizing the skills of our Research & Development Department who will team up with our Procurement Manager and work with suppliers to perform alternative material searches or to find a material that meets the property requirements of your intended application. For commonly used items, Compounding Solutions can reduce your lead times and offer small compound lots using raw materials that may typically have large minimum purchase requirements. In cases of sudden material shortages or discontinued materials, Compounding Solutions can help to gather critical and accurate information, secure stock, or arrange bulk last time purchases. Our Quality Management System is designed in a way that not only dictates a set of checks and balances to ensure supplier authenticity, quality, and reliability, but also provides the flexibility necessary to allow prompt processing and approvals for time sensitive requests.


Color Matching

Work with our team of color experts today to achieve the desired color for your device!

Our team has a lengthy reputation for providing accurate colormatches for a wide range of medical device applications. From existing parts to the Pantone Matching System, color concentrates to
pre-colored compounds, our team of experts develops custom formulations that provide consistency and compliance.

Color selection in the product design process is often decided by the marketing team but it is a key part for the design, especially within the medical device industry. In recent years, the FDA has imposed more strict standards and approvals on colorants used in medical devices, which can also limit the final color options available for medical devices depending on final end use.

In the medical device industry, colorants fall into two main areas of FDA approvals. Colorants approved under FDA 21 CFR 173-178 are considered to be “Food Grade”. The FDA has moved, in recent years, to expand the 21 CFR 73 Subpart D listings to include any device that has blood or body fluid contact. This list of colorants for use in medical devices are exempt from batch certification. The selection of initial pigments can greatly impact the FDA approval process for medical devices. Without proper selection rejection of the device is possible

Contact us today to discuss your desired color and help ensure a smooth FDA approval process.

For a list of colors that can be achieved utilizing FDA 21 CFR 73 Subpart D approved colorants, visit our EZ Med Color Selector!

EZ Med Color Selector


Dry Blending

Compounding Solutions can provide anything from highly technical compounding needs to very basic homogenization of your existing pelletized resins and powders. This can be done in quantities as little as one pound or scale up to truck loads as needed via ribbon or tumble blending. As a simple example the blending of High Density Polyethylene and Low Density Polyethylene to create a Medium Density Polyethylene can be done in a dry blending method simply by effective drum mixing. Many organization do this by tumbling materials in a plastic bag or in any bin available for on demand needs. Our team has taken a more science based approach and removed the human element to ensure consistency.

Through the years, we have used several different effective methods however we have conducted validation trials to confirm the best methods. Based on quantities and materials types we have paths for the most effective homogenization. Experimenting with a range of bin sizes and fill levels we have found that adjusting these parameters will provide the best distribution possible for your needs. Overfilling the bins will create problems as will underfilling. A balance of both fill level and time in agitation provide consistency.

Mix with Science not speculation! Contact Compounding Solutions today! …Contact Us


Regulatory Support

Compounding Solutions is committed to assisting our customers in the complex world of regulation. The demand for high quality medical plastics and compounds continues to grow as regulations become more stringent, technology advances, and new, life saving medical devices are developed. Compounding Solutions is dedicated in providing all the necessary components (many listed below) needed for our customers to get through their product approval processes around the world.

> Animal Content (Bovine Spongiform or Transmissible Spongiform)
> ASTM / ISO / USP
> Bisphenol A (BPA)
> California Proposition 65
> Cas #s
> CMA – component material assessment
> Conflict Minerals (Dodd-Frank Wall Street Reform and Consumer Protection Act)
> Country of Origin
> FDA 21 CFR Subpart D
> FDA Food Allergens
> Genetically Modified Organisms (GMO)
> Gluten-Free
> Halogenated Flame Retardants
> Human Derivatives
> Lactose-Free
> Latex
> Material containing HAP(s)
> Medical Substances
> Melamine
> Nano-Materials
> Polyvinyl Chloride (PVC)
> Reach
> Restricted Substances
> ROHS
> SDS (Safety Data Sheets)

Contact Compounding Solutions Regulatory staff to request documentation that a Compounding Solutions compound has compliance with governing regulations and/or a defined standard.


Specification Management

Compounding Solutions holds a wide array of capabilities with the ability to design strict specifications around a given customer’s product requirements. Please refer to our testing services section QA Testing for a detailed list of testing equipment we hold in our lab. Testing services range from mechanical testing, physical testing, impact testing, rheology testing, compound testing, visual and electrical testing equipment.

Compounding Solutions has over 15 years of data history, with extensive knowledge on materials/additives differences and variation. This breadth of knowledge will continue to grow into the future and is yours to tap into. Our dedicated Record Retention Area in the facility holds a file for each compound created to date at Compounding Solutions, enabling immediate retrieval of info from material we have produced.

Our organization is certified to ISO 13485. The ISO 13485 certificate shows a commitment to our customers, and that our organization demonstrates the ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. While we are considered a supplier to the Medical Device industry, we hold ourselves to the same standard.

These services give Compounding Solutions the capability to identify as well as characterize your materials to a high degree. Our insight can help you to comprehend how suitable the compound or materials are for your application. Our wide gamut of testing services and in house material expertise is available for customers to put at their disposal.