Innovative manufacturing processes and in-depth industry knowledge have placed Plastikon among the leaders in the global healthcare market. Unique in our ability to deliver a diverse range of services, this project exemplifies how our outstanding project management skills and a team of dedicated experts enabled us to effectively execute the production and packaging of a liquid dose drug delivery system for a customer in the pharmaceutical/medical device industry.

To meet the stringent standards inherent with a project such as this, production was carried out in our ISO Class 5 cleanroom. Liquid manufacture incorporated full analytical chemistry support as well as establishment of efficient commercialization technologies developed in accordance with strict FDA and ISO 13485 standards. Highly automated and precision calibrated blow-fill-seal packaging lines, fully enclosed and impervious to infiltration, were capable of delivering multiple dosage and package types. Servo-driven stations controlled labeling, dosing, and capping to ensure repeatable outcome for every production lot. Advanced analytics, sophisticated instrumentation, material certifications, performance assays, and full lot traceability formed the foundation for fail-safe quality control.

Strategic planning, in-depth industry knowledge, and comprehensive engineering, accelerated time-to-market and helped the customer gain a competitive edge in a very aggressive marketplace. As global industry professionals, we operate with the utmost integrity and protect intellectual property rights both here and abroad. We remain a trusted partner of this customer, and continue to manufacture 30 million units/year.

More detail about this project can be found in the table below. We encourage you to contact us to learn how we can support your application requirements.

 

Highlights of the Contract Liquid Manufacturing and Packaging Project

Product Description/Scope

  • Pharmaceutical/Medical Device
  • Contract Liquid Manufacturing and Packaging

Contract Manufacturing Capabilities Applied/Processes

  • Product Development
  • Project Management: PMP Accredited Specialist
  • Clinical Trials Services
  • Full Transfer, process optimization, and validation
  • Labeling & Packaging Services – Unit dose, Lot size, Barcode.
  • Full Analytical chemistry support laboratory for formulation development.
  • Distribution for Stock to Dock

Equipment Used to Manufacture Part

  • Multiple lines of BFS and Liquid Fill/Packaging Lines.

Special Features

Development

  • Proven ability to develop and successfully transfer oral drug delivery technologies to our own manufacturing sites and sites of developing partners
  • Establish technologies for development and commercialization
  • Full analytical chemistry support for formulation development including HPLC, dissolution testing and physical characterization
  • Product Distribution
  • Quality Water Systems (Deionizer, Reverse Osmosis, Ozonated Reverse Osmosis)
  • Analytical development method development and validation

Fill Range

  • 0.2 ml – 1,000 ml (At a rate of up to 15,000 units per hour)

Material Used

  • LDPE, HDPE, Glass, Ampoule

Material Finish

  • Multiple Grades
  • Embossing, Pad Printing, Coating, Hot Stamping, Painting

Packaging

  • 12 tanks range from 1K liters to 12K liters
  • Calibrated load cells and display
  • Bottom to bottom transfer capabilities
  • Recirculation capabilities with filtration and homogenizer options
  • Vacuum charging system
  • Inline filtration system
  • Clean in place and Steam in place systems

In process testing/inspection performed

Complete Unit Production within ISO Class 5 Environment

  • Verification – External Certification & Internal Monitoring
  • Testing – Certificated to ISO 13485 clean room standards
  • Cellular – Clean room production from formulation to filling
  • Labeling, Dosing and Capping all controlled via Servo- driven stations; repeatable outcome for every production lot

Analytical & Custom Quality Control Specifications

  • MCompendiandial Testing
  • Material Certification
  • Sensitive Analytical Testing (Chromatography, ICP, FTIR, Titration)
  • Spectrophotometric Testing
  • Bioburden Testing
  • End toxin Testing
  • Custom Functional & Performance Assays
  • Material Origin Control
  • Full Lot Traceability
  • Products Tested and Retained

Industry for Use

  • Pharmaceutical and Medical Device Manufacturing

Typical Applications

  • Aseptic Liquids and creams filling
  • Vial Filling
  • Bottles filling
  • IV Bag
  • Ampoules
  • Plastic Extrusion
  • Syringes fill (Glass)
  • Blisters
  • Tubes

Volume

  • 30,000,000 units of 30 ml Yearly

Delivery Location

  • Global Distribution Specialist

Standards Met

  • Customer Specifications
  • CGMP, FDA, ISO 13485, CE

Product Name

  • BFS (Blow Fill Seal) Technology