Center for Development and Production of Highly Potent Drugs
TZF Polfa, a Polish pharmaceutical manufacturer, proudly presents its latest investment located in Warsaw – the Center for Development and Production of Highly Potent Drugs, one of the most advanced injectable drug manufacturing facilities in Europe. This technologically advanced plant fully responds to the growing global demand for injectable medicines in various pharmaceutical forms.
The facility covers over 12,000 m², including 3,000 m² of cleanroom areas, and has been designed in accordance with the latest GMP requirements.
At the heart of the Center are two modern production lines – ONCO and COMBO – enabling the manufacturing of drugs of different activity classes (including highly potent) in multiple dosage forms and packaging configurations.
ONCO LINE – Aseptic Filling of Prefilled Syringes and Vials with Solution, Including Lyophilization
The ONCO Line has been designed for handling substances that require the highest level of operational safety. It is capable of processing materials with toxicity levels up to OEB 5. By implementing isolator technology and full robotization, the line ensures maximum safety for operators and eliminates the risk of cross-contamination.
The line supports a wide range of packaging materials: vials (2R–50R) and prefilled syringes (0.5–5 ml). Its output capacity reaches up to 6 million units per year, depending on the product and applied technology.
COMBO LINE – Multifunctional Line for Aseptic Filling of Vials with Powders and Solutions, Including Lyophilization
The COMBO Line is a highly flexible aseptic filling system for the production of liquid, powder, and lyophilized drug forms. It operates with a wide range of vial sizes (2R–50R) and is equipped with isolator technology and 100% in-process control, ensuring maximum sterility, automatic inspection, and full GMP compliance.
Its production capacity reaches up to 20 million vials annually.
Both lines cover all stages of sterile production – from raw materials, filling, and closing to individual and collective packaging and quality control – ensuring maximum technical and cost efficiency.
Applied Technologies and Global Standards
The Center features its own Research & Development (R&D) department supporting product optimization, modern Quality Control (QC) and stability testing laboratories, as well as dedicated API and Finished Dosage Form (FDF) storage zones. It has been designed to meet current EU GMP, FDA, and EAEU regulatory requirements.
- Compliance with international GMP (EU), FDA, and EAEU standards
- Full isolator technology ensuring maximum aseptic conditions and operational safety
- 100% in-process control and automatic inspection systems
- Fully robotized production line (ONCO Line)
- Integrated waste management system
ONCO LINE
- Handles vials (2R, 6R, 10R, 20R, 30R, 50R) and prefilled syringes (0.5 ml, 1 ml, 5 ml), as well as lyophilized forms
- Designed for handling highly potent substances up to OEB 5
- Capacity: up to 6 million units per year
- Fully automated isolator-based system utilizing single-use components
- Integrated waste management and in-process control systems
COMBO LINE
- Handles vials of 2R, 8R, 10R, 30R, and 50R volumes
- Enables production of liquid, powder, and lyophilized drug forms
- Capacity: up to 20 million vials per year
- Isolator-based aseptic technology with full process control and automatic inspection
- Rapid changeovers between different pharmaceutical forms
- Covers all stages of sterile production – from raw materials to final packaging
Laboratory and Support Facilities
- In-house Research & Development (R&D) department for product optimization and development
- Quality Control (QC) and stability testing laboratories
- API and Finished Dosage Form (FDF) storage areas