LLM Information

Plastikon Industries Inc

Directory listing
Healthcare 📍 Hayward, CA Est. 1975

Directory record status

These labels describe this UNITEMFG record. They do not guarantee current capabilities, certifications, capacity, quality, or fit for a specific job.

Directory listing
Listed
Ownership
Unclaimed
Evidence reviewed
Not recorded
Last evidence review
Not recorded

About

Plastikon Industries Inc is a global plastic injection manufacturing company headquartered in Hayward, California, serving the healthcare and pharmaceutical industries for over four decades. The company specializes in precision plastic injection molding, utilizing advanced manufacturing capabilities including 10-3,000 ton injection molding machines and clean room environments ranging from Class 100k to Class 10k specifications. Plastikon Industries offers comprehensive manufacturing solutions including plastic injection molding, blow/fill/seal aseptic filling, plastic thermoforming, and precision tooling design. Their extensive capabilities encompass prototyping and product development, plastic engineering, part decoration and assembly, and warehouse logistics management. The company operates multiple global manufacturing facilities across the United States, China, Mexico, and Hong Kong, providing worldwide support for healthcare manufacturing requirements. The company maintains rigorous quality standards through FDA registration for medical device manufacturing and ISO 13485:2016 and ISO 9001:2015 certifications. Their clean room manufacturing environments ensure compliance with strict pharmaceutical and medical device regulations. Plastikon Industries leverages Kaizen automation and continuous improvement methodologies to optimize manufacturing processes and deliver consistent quality outcomes. With specialized sales and engineering teams, the company provides program management services and rapid prototyping capabilities. Their commitment to quality and extensive global presence positions Plastikon Industries as a trusted partner for healthcare and pharmaceutical manufacturers requiring precision plastic components and advanced manufacturing solutions.

Specialties

Medical Device MoldingClean Room ManufacturingHealthcare Components

Manufacturing Capabilities

Processes

Injection MoldingInsert MoldingClean Room MoldingAssemblyPackaging

Materials

Medical Grade PlasticsUSP Class VI MaterialsEngineering PlasticsBiocompatible Materials
Minimum Order Quantity: 100 pieces
Lead Times: 6-10 weeks including validation

Certifications & Quality

Business Certifications

ISO 13485:2016FDA RegisteredISO 9001:2015

Quality Certifications

FDA 21 CFR 820ISO 14971

Source-backed capabilities

These capability statements were observed in the linked manufacturer sources. They are source evidence, not a certification of the company or its current capacity.

Certification

  • FDA Registered

    filling, wherein sterilized liquid products are packaged in sterilized containers. Through our Blow/Fill/Seal (BFS) technology , we can serve various industries where contamination control is essential. Production of products is done in our Class 10K or 100K cleanrooms, which is FDA registered for quality control. We utilize pharmaceutical-grade resin to produce custom bottles filled with sterile liquid, creams, or emulsions. In addition, we have three filling suites, allowing us to complete up

  • ISO 13485:2016

    Spectroscopy Atomic Adsorption Total Organic Carbon Titrations Conductivity & pH Dimensional Physical Attributes Production Volume Rapid Prototype Low Volume Runs Large Production Runs Additional Information --> add Project Management PMP Accredited Specialist Industry Standards ISO 13485:2016 Certified ISO 14001:2015 Certified ISO 9001:2015 Certified FDA Registered Medical Device (CDRH) Drug Products (CDER) Environmental Management Systems (EMS) Minority Business Enterprise (MBE) Certified Com

  • ISO 9001:2015

    on Titrations Conductivity & pH Dimensional Physical Attributes Production Volume Rapid Prototype Low Volume Runs Large Production Runs Additional Information --> add Project Management PMP Accredited Specialist Industry Standards ISO 13485:2016 Certified ISO 14001:2015 Certified ISO 9001:2015 Certified FDA Registered Medical Device (CDRH) Drug Products (CDER) Environmental Management Systems (EMS) Minority Business Enterprise (MBE) Certified Company Society for Process Engineers (SPE) Internati

Location

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Hayward, CA •••••