Plastikon 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.
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.
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
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)
International Society for Pharmaceutical Engineering (ISPE)
Efficiency
Six Sigma Certification
Lean Manufacturing
Kaizen
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