Finished Product Assembly and Packaging (FinPack)

Integrating Drug Product into Complex Drug Delivery Devices

Nypro’s Finished Product Assembly & Packaging (FinPack) group provides drug/reagent product assembly & packaging services to pharmaceutical and diagnostic customers.  Located at the Nypro headquarters in Clinton, Massachusetts, we have a dedicated FDA registered and audited cGMP manufacturing area.  Our Quality Management System is CFR 820, 210/211 Part 4 and 600 (biologics) compliant and the site has successfully passed Pre-Approval Inspection (PAI) audits by CDER and CDRH.  

Nypro FinPack supports our customers throughout the product lifecycle, including:

  • Focus Group Studies
  • Engineering Builds
  • Device Verification Testing and Support
  • Phase I, II & III Clinicals
  • High Volume Production

Exisiting solution outsourcing or transfers Nypro FinPack can support the following drug packaging formats:

  • Metered Dose Inhaler (MDI) Canisters
  • Pre-Filled Syringes (PFS) & Cartridges
  • Tablets
  • Web Blisters
  • Dry Powder Inhaler (DPI) Reservoirs

Service Offerings

Pharmaceutical

  • Integration of pre-filled drugs into combination products
  • Kitting, packaging and labeling of finished goods including instructions for use
  • Capabilities include: Pre-filled liquid/powder container control and integration, drug compliant quality system, small and large molecule controls (biologics), label control, high-speed assembly and packaging, engineering and clinical builds
  • Requirements include: Low rRelative Humidty (RH), light sensitivity, 2-8C cold chain management, sterilization, Unique Device Identification (UDI) and expiration dating 

Diagnostics

  • Metering and dispensing of reagents and buffers into diagnostic consumables
  • Pouching and cartoning of finished goods including instructions for use and calibration cards
  • Capabilities include: Liquid metering, lyophilized pellet/powder metering, thawing/degassing, reagent drying, calibration, high-speed assembly and packaging, and engineering builds
  • Requirements include: Low RH, light sensitivity, 2-8C/-20C/-80C cold chain management and expiration dating