Manufacture of Medical Devices & Aerospace Components

Cleanroom Plastic Injection Molding & Thermoforming

In order to address the manufacturing needs of medical device and Aerospace businesses, Baldwin Manufacturing Company has incorporated extremely high standards that meet or exceed requirements set by the quality and safety monitoring organizations for these industries. You can learn more about plastic injection molding and thermoforming services and our modern production capabilities on this page. When you’re ready to get to work, Charlie Baldwin would be happy to answer your questions and provide a price quote for your unique project.

What is Plastic Injection Molding?

Plastic injection molding is a process for creating plastic products, using tool steel molds. To create your product, pre-colored plastic pellets are melted, injected into molds under high pressure (8,000 to 20,000 PSI), cooled and ejected. This is an efficient, fast, and easily repeated process that can quickly and precisely produce numerous finished goods in a short time frame. The component parts can be manufactured for assembly via snap fits, fasteners, adhesive, and welding.

What is Thermoforming?

Thermoforming is a process that uses a sheet of plastic that is heated and softened to allow for molding. Then, using a vacuum, the sheet of softened plastic is formed around a mold. This process can be used to make everything from pudding cups to dog dishes, and it is often utilized to create aerospace components such as aircraft engine covers, flexible dust covers, and delicate instrument storage containers.

ISO 13485 Cleanroom Plastic Injection Molding

The International Standards Organization (ISO) sets regulations for many business processes, including ISO 13485, the standard on clean room plastic injection molding for medical devices. Cleanroom plastic injection molding is a manufacturing process that takes place in an enclosed, positive pressure room. A cleanroom is maintained by moving clean air through the room and preventing “dirty” air from returning. Our cleanroom is a Class 7. To ensure the room is clean, we use ultra-high particulate air filters, lint free suits, positive air pressure systems, and other preventive measures that meet or exceed ISO 13485 standards.

AS9100 Aerospace Plastic Injection Molding & Thermoforming

The International Aerospace Quality Group sets manufacturing standards for products that can be used in aircraft, including AS9100, the policy sets processes and restrictions on items produced through plastic injection molding and thermoforming. Meeting or exceeding this manufacturing standard is essential to ensure safety, and we follow the requirements of AS9100 to the letter, ensuring perfectly functioning, quality products.

Our Plastic Injection Molding Quality & Safety Standards

We always meet or exceed standards set by the following organizations:

  • International Standards Organization Policy on Medical Devices (ISO 13485)

  • The International Aerospace Quality Group Policy on Aerospace Products (AS9100)

Our business maintains memberships in these professional organization that set and monitor quality and safety standards within the industry to ensure accountability:

  • Small Business Enterprise

  • Minority Business Enterprise

  • Women Owned Small Business

  • California Public Utilities Commission

 

Services We Provide

Using plastic injection molding and thermoforming on a contract manufacturing basis, we are able to offer a complete range of value-added services, including:

  • Class 7 cleanroom molding and assembly.

  • Product design and tailored packaging.

  • Drilling, tapping and threaded and ultrasonic inserting.

  • Overmolding and insert molding.

  • Hot stamping, heat staking, and pad printing.

  • Painting & EMI shielding.

  • Micro precision molding.

  • Thermoformed clamshell, blister packs, and electrostatic discharge packaging trays.

Our Production Capabilities

Using a range of materials and plastic injection molding and thermoforming techniques, we can offer customized production for businesses of all sizes. Our contract manufacturing capabilities include:

  • Quality tooling is made off-site by our long-time partner located in then shipped to our manufacturing facility.

  • In-house we offer rapid prototype tooling, which is typically completed in two weeks, using quick molds, 3D prints, and laser forms. Great for those who need just a few products or samples.

  • We use a range of plastic molding technologies, including collapsible cores, stack molds, hot and cold runners, and edge and sub gated molds.

  • We have expertise in using a wide range of high temperature and engineering grade plastics for demanding applications.

  • We use small to medium injection molding presses, between 15 and 800 tons.

  • Our ISO 13485 standard products include electro-medical equipment, irradiation apparatuses, surgical and medical instruments, surgical appliances and supplies, and dental equipment and supplies.

  • Our AS9100 standard products include aircraft parts, missile components, and spacecraft products.

How to Work with Baldwin Manufacturing Company

Baldwin Manufacturing Company is located in Redwood City, CA, and we proudly partner with several world-class manufacturing facilities for engineered metal and plastics. All of our manufacturing facilities are located in California and Nevada. Our team members are highly trained and certified in their area of manufacture, and we use this expertise to help businesses – like yours – create component parts and end products that achieve their goals. We know you have other options when it comes to Plastic Injection Molded products, but we hope you’ll choose to partner with us. We promise to go the extra mile to make the process flexible, fast, and cost-effective for your business.

At other manufacturing companies, your needs have to be molded to fit their structure. At Baldwin Manufacturing Company, we have the flexibility to allow your design to dictate our process, relying on cost-effective and scalable techniques and higher quality materials.

Call Charlie now to solve your manufacturing challenges.

Baldwin Manufacturing has the technical expertise and manufacturing resources to meet the most demanding specifications. From prototype to large scale production while meeting ISO 13485 and AS9100 requirements.