Sonolite Plastics Corporation

Precision
Applicators

Market-driven development of proprietary plastic applicator components — FDA-compliant, manufactured in the USA since 1963.

🇺🇸Made in USA FDA Compliant 📋ISO 9001:2015 ♻️Recyclable
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Enema Applicator
Enema Applicator Threaded & Snap-on
Vaginal Douche
Vaginal Douche Coming soon
Founded 1963
Manufactured in USA
FDA Compliant Materials
100% Recyclable Components
Fully Automated Assembly
Controlled Environment
Our Story

Heritage Meets Innovation

Six decades of expertise in regulated healthcare manufacturing, now backed by PCPI's precision molding capabilities.

Founded in 1963, Sonolite Plastics specialized in the development and manufacturing of enema applicators, feminine care, and pharmaceutical products — building deep expertise in regulated healthcare applications over more than six decades.

Following the acquisition by PCPI Plastics, Sonolite operates with a distinct approach: rather than waiting for client briefs, Sonolite actively engages the market — identifying unmet needs and developing proprietary products that address real clinical and consumer challenges.

Each product is developed one at a time, with depth and precision, combining institutional expertise with advanced injection molding capabilities.

60+
Years in Business
FDA
Compliant Materials
ISO
9001:2015 Certified
USA
DeGraff, Ohio
Sonolite Enema Applicator color range
A Division of PCPI Plastics, LLC
Products

Our Product Line

Proprietary applicator components developed through direct market engagement — precision-engineered, FDA-compliant, available for OEM integration.

Available Now

Enema Applicator

Available in two configurations to fit threaded and non-threaded bottle closures. All materials FDA-compliant and fully recyclable.

Enema Applicator — color range

Available in multiple colors

Threaded — Green
Threaded
Standard screw-on fit — compatible with threaded bottle closures
Snap-on — Blue
Snap-on
Non-threaded press-fit — no rotation required for assembly
Regulatory & Material Specifications
  • Type III DMF through vendor
  • 21 CFR 177.2600 — rubber articles for repeated use
  • 21 CFR 177.1210 — closures with sealing gaskets
  • Absence of Nitrosamines and Nitrocellulose
  • Does not promote microbial growth
  • USFDA food allergen guidelines compliant
  • Applicator, valve & shield — fully recyclable
  • Fully automated assembly in controlled environment
In Development
Coming Soon

Vaginal Douche

Proprietary vaginal irrigation applicator currently in development — engineered to the same FDA-compliant standards as our enema line.

Vaginal Douche — front view
Vaginal Douche — angle showing thread
Product Overview
  • Proprietary design developed from direct market research
  • Multi-port tip for uniform irrigation
  • Internal threaded base for secure bottle attachment
  • FDA-compliant materials — same standard as enema line
  • Designed for OEM integration with standard bottle formats

Interested in this product? Contact us to register your interest and receive updates on availability.

Register Interest →
Why Sonolite

Built for Demanding Applications

🏭
USA Manufacturing

All products manufactured in DeGraff, Ohio under strict quality control and a 100% domestic supply chain.

🔬
Market-Driven Development

We identify real market needs before developing — each product is proprietary, built from clinical and consumer insight.

⚙️
Precision Engineering

Advanced tight-tolerance injection molding backed by PCPI's scientific molding capabilities and process control.

♻️
Sustainable Design

Applicator, valve, and shield are fully recyclable and designed for minimal environmental footprint.

🤝
B2B Integration

Our components complete your product — we work with brands, labs, and manufacturers for seamless OEM integration.

📋
Full Documentation

Drug Master Files, material safety data sheets, technical drawings, and compliance documentation on request.

Compliance & Quality

Certified to the Highest Standards

🇺🇸
FDA Compliant
All materials meet U.S. FDA requirements for pharmaceutical and medical applications
📋
ISO 9001:2015
Certified quality management system ensuring consistent process control and reliability
📄
Type III DMF
Drug Master File documentation available for streamlined regulatory submissions
21 CFR Compliant
Meets 21 CFR 177.2600 and 21 CFR 177.1210 standards for rubber articles and closures
Get in Touch

Request a Quote

Our team is available to discuss product specifications, samples, and pricing for OEM and custom integration. Attach technical drawings or RFQs directly to your inquiry.

📍
Address4590 County Road 35
DeGraff, Ohio 43318-9770
📞
Toll Free(800) 274-5515
✉️
Emailinfo@pcpiplastics.com
🌐
Websonoliteplastics.com
A Division of PCPI Plastics, LLC
Technical drawings, RFQs, or specifications

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