Cutting Edge Innovation in Plastics

Plastikon Healthcare provides custom blow molding and aseptic liquid fill contract manufacturing. Our one-step process uses Blow/Fill/Seal (BFS) technology for a range of customers, in a variety of industries. Product development is completed in our FDA registered, Class 10K or 100K cleanrooms. We operate in compliance with ISO 13485:2003, and ISO 9001:2008 regulations, and strictly follow the Current Good Manufacturing Practices (cGMP) per 21CFR 210-211 and Quality Management System per 21CFR-820. In addition, we are environmentally sensitive with ISO 14001:2004 certification.

Our B/F/S system utilizes LDPE, or pharmaceutical grade resin, to produce custom bottles filled with sterile liquid, emulsions, or creams in volumes from 0.2-mL to 1000-mL. We operate three filling suites that are capable of producing up to 10,000 units per hour. Our plastics manufacturing capabilities include bottom-to-bottom transfer and recirculation with filtering and homogenization options. We also use validated methods for formulation development. Our engineering staff and PMP certified project managers work with our customers from conception to final product. With our on-site Laboratory Services, we ensure only the highest quality standards are met throughout your product lifecycle with raw material, in-process, finished product, and stability testing. For more information about our customized plastic blow molding and Blow/Fill/Seal technology, contact us directly.

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Industry Focus

  • Diagnostics
  • Medical Device
  • Pharmaceutical
  • Nutraceutical

Fill Volume Range

  • 0.2 to 1000 ml

Testing

  • Raw Material Compendia
  • In-process Inspection
  • Finished Product Release
  • Stability

State-of-the-Art Custom Plastic Blow Manufacture & B/F/S Aseptic Liquid Filling Capabilities

Clean Rooms Designed and Validated to FDA Standards

  • Class 10,000 Clean Rooms with Gowning Room Access
  • Optical Clean Room Packaging Suites
  • Pressure Cascades to minimize microbial and particulate egress
  • Temperature controlled environment
  • Environmental monitoring program for particulate and microbial

Formulation Development

  • Product Transfers
  • Generic Drug Applications
  • HPLC Analysis
  • Physical Characterization
  • Microbial Attributes and Preservative Effectiveness

Environment

  • Class 10K and 100K Cleanrooms
  • Class 100K Formulation Area

Equipment and Processes Validated to FDA Standards

  • Performed under an approved Validation Master Plan
  • FAT and SAT of BFS Equipment at Start-Up
  • Qualification/Validation of BFS Equipment and Components
  • Performance Qualification of Sterile Line, Including Media Simulation Activities
  • Audited by Quality and ISO certified Auditors

Formulation Capacity

  • Wide range of bulk liquid, emulsions, and creams
  • 11 Stainless Steel Tanks range from 1,000 liters to 12,000 liters
  • Small Scale vessels from 1 liter to 50 liters
  • Clean in place and Steam in place systems
  • Calibrated load cells and display
  • Bottom to bottom transfer capabilities
  • Recirculation capabilities with filtration and homogenizer options

Reports

  • Statistical Process
  • Repeatability
  • FMEAs
  • Internal & Supplier Corrective Action
  • Lot Code Traceability & Product Retains

Equipment

  • Weiler BFS Machines
  • Clinical Development Production Tools
  • Calibrated Load Cells and Display
  • Vacuum Charging System
  • Inline Filtration System
  • Clean in Place and Steam in Place Systems
  • USP Purified Water System
  • Clean Steam Generator

cGMP Microbiology Laboratory

  • Microbial Toxicity Testing
  • Microbial Count and Bioburden
  • Sterility Testing
  • Media Suitability
  • Environmental Monitoring

Additional Services

  • Bar Coding
  • Labeling
  • Packaging
  • Sub-Assemblies
  • Engineering Services
  • Research & Development
  • Sales & Marketing
  • Program Management
  • Project Management
  • Part Design
  • Warehousing
  • Logistics
  • Distribution

Material

  • LDPE
  • Pharmaceutical Grade Resin

cGMP Analytical Chemistry Laboratory

  • HPLC & Spectroscopy
  • Atomic Adsorption
  • Total Organic Carbon
  • Titrations
  • Conductivity & pH
  • Dimensional Physical Attributes

Production Volume

  • Rapid Prototype
  • Low Volume Runs
  • Large Production Runs

Additional Information

Project Management

  • PMP Accredited Specialist

Industry Standards

  • ISO 13485:2003 Certified
  • ISO 14001:2004 Certified
  • ISO 9001:2008 Certified
  • FDA Registered
  • Medical Device (CDRH)
  • Drug Products (CDER)
  • Environmental Management Systems (EMS)
  • Minority Business Enterprise (MBE) Certified Company
  • Society for Process Engineers (SPE)
  • International Society for Pharmaceutical Engineering (ISPE)

Efficiency

  • Six Sigma Certification
  • Lean Manufacturing
  • Kaizen