ABN Cleanroom Technology has launched a turnkey rental solution for the production of cytostatics called CYTONIX.
The move comes as new pharmaceutical inspection regulations for 2026 are set to take effect in Belgian hospitals, which will reshape how cytostatics can be produced and handled.
PIC/S regulations, known as the Pharmaceutical Inspection Co-Operation Scheme, is an international non-binding arrangement between regulatory authorities that aims to harmonise good manufacturing practice (GMP) standards and inspection procedures for pharmaceuticals.
Starting in 2026, Belgian hospital pharmacies will be held to new compliance standards and regulatory framework designed to tighten the quality and safety standards for in-hospital compounding, including cytostatics.
The changes require:
- hospitals to upgrade from conventional pharmacy setups to GMP-validated cleanrooms or isolators with controlled environments, dedicated airflows, and validated decontamination systems.
- For cytostatics — hazardous, sterile cancer drugs — the focus is on preventing cross-contamination, ensuring sterility, correct dosing, and full traceability.
- Hospitals must implement comprehensive quality systems, documentation, training, and environmental monitoring, along with validation of facilities, equipment, and air handling.
- Personnel protection, gowning, and cleaning protocols are also mandated to meet occupational and product safety requirements.
Because few Belgian hospitals currently meet these standards, many will need to invest in new infrastructure, validate existing facilities, or turn to modular, pre-validated solutions to achieve compliance before the 2026 deadline.
ABN Cleanroom Technology’s CYTONIX offers a solution to some of the bottlenecks posed by the upcoming regulatory changes.
To provide a direct answer to the PIC/S sterility and contamination-control requirements, CYTONIX features a complete setup, including a Stericube Velox, or mobile, modular cleanroom.
The cleanroom includes two isolators with independent in/out airlocks and a H₂O₂ generator to ensure full aseptic isolation and validated decontamination.
Both the isolators and modular cube are pre-validated, meaning hospitals don’t need to start qualification from scratch, which can save months of work.
The package from ABN Cleanroom Technology also is all-in-one. This means it includes HVAC, utilities, commissioning, and testing that is pre-integrated and required for environmental control and documentation.
ABN Cleanroom Technology can also deliver, install and validate CYTONIX in record time, which will be ideal for hospitals facing the 2026 deadline or needing temporary cytostatics capacity during renovations or compliance upgrades.
ABN Cleanroom Technology has long collaborated on innovative projects with Belgian hospitals, including the launch of the new Celvia product platform.
CYTONIX allows Belgian hospitals to rent a fully compliant, isolated and ready-to-use environment which meets the new PIC/S standards for cytostatics.
