Contract Manufacturing

Pre-Filled Syringes @ ITALFARMACO SPA Plant in Milano

Italfarmaco SPA is a manufacturer of Pre-Filled Syringes since 1987. So far, the total manufacturing output is well beyond 80 million units, ranking the company first in Italy and among the international level for this type of technology.

Italfarmaco SPA improved the knowhow and reliability of the Pre-Filled Syringes production process, developing original solutions to industrial problems related to both filling and packaging of the product.

Italfarmaco is able to produce at competitive costs and can therefore propose itself as an ideal CONTRACT MANUFACTURER to companies which intend to market new or established products in Pre-Filled Syringes.

Cytoxic Finished Dosage Formulation

“state of the art” technology, injectable department and related utilities.

SCADA (Supervisor Control and Data Acquisition) system that keeps and traces records of trends and interventions according to CFR 21 part 11 and GAMP 4

  • HVAC: three different Air Handling Units provide highly standardized thermo-hygrometric conditions and prefiltration of incoming and recirculated air; ventilating units that provide more than 300 recirculation of air through HEPA filters.
  • PURIFIED WATER SYSTEM: a 4,000 litres/hr Reverse Osmosys distiller provides Purified Water to a dedicated sanitary distribution loop.
  • WATER FOR INJECTION: different multiple effect stilmas distillers produce continuously WFI from PW to feed the distribution loop (capacity 190L/hr).
  • CLEAN STEAM: completely dedicated for use in injectable department and used for autoclave sterilization cycles and SIP cycles of the preparation system.
  • Disposable bags technology for compounding and/or storage
  • CIP/SIP stainless steel dissolution vessels (up 200 and 400L)
  • Different syringes filling lines (5K-20K unit/hr) and ampoules filling machine (5K unit/hr)
  • Denesting machines
  • Automatic Inspection machines
  • Blistering and boxing machines
  • Autoclaves for components and terminal sterilization
  • Different bins and blenders (up to 1400L capacity)
  • Various sizing equipment
  • Direct Blending and Wet Granulation
  • High Speed Tabletting machine (up to 260K units/hours)
  • Capsule filling (60K cps/hr)
  • The manufacturing process of prefilled syringes consists of the following main integrated steps:
  • Bulk solution preparation
  • Aseptic filling
  • Sterilization
  • Packaging with fully automatized packaging line equipped with the most recent video camera control systems
  • Italfarmaco has an organized Quality Assurance and Control System that allows the pharmaceutical plant to fully comply with the highest quality standards (FDA and European GMP).
  • The QC Laboratories (Chemical and Microbiological) are equipped to carry out most of the compendial tests and more specifically activity determination of heparins.
  • QC microbiological lab, besides the routine test of the products (microbial count, sterility, LAL etc.) carries out also microbiological environmental controls of the injectable department for surfaces, air and operators.
  • The pharmaceutical plant is regularly inspected by the Italian Health Ministry (according to the EU cGMP’s). Since 2004 the plant has been inspected and approved by FDA for aseptically filled products (last FDA inspection took place in March 2015).

Italfarmaco developed for itself and its customers a WFI prefilled syringe that can be used as a diluent for any injectable pharmaceutical product that must be reconstituted before administration to patients.