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Grade A ISO 5 vial washing, depyrogenation tunnels, liquid filling, rubber stoppering, and aluminum crimping under isolator / RABS enclosures.
Sterile parenteral manufacturing demands uncompromising sterility assurance and particulate control conforming to the 2022 EU GMP Annex 1 revision. GentlemanPharmed provides complete sterile processing lines for glass vials, ampoules, and pre-filled syringes.
Maintaining continuous Grade A aerodynamic laminar flow, zero particulate generation from moving mechanical linkages, and gentle liquid handling for shear-sensitive proteins and monoclonal antibodies.
Our aseptic lines feature valveless ceramic rotary piston pumps, peristaltic liquid dosing, Grade A unidirectional laminar airflow tunnels (320°C for 3-log endotoxin reduction), and integrated continuous viable and non-viable particle monitoring.
Rotary ultrasonic vial washing, continuous depyrogenation tunnel, and 8-head liquid filling with vacuum stoppering.
High-speed rotary ampoule washing, sterilization, and hermetic flame sealing under nitrogen flush.
Passive and active RABS enclosures isolating filling zones from cleanroom operator contact.
Aseptic process validation follows the 2022 EU GMP Annex 1 revision: media fill trials under full production conditions, continuous viable and non-viable particle monitoring, and container-closure integrity testing on every fill format qualified on the line.
Commissioning includes on-site requalification support after any format change, since a sterile line's validated state is tied to the exact configuration it was qualified in.
Our engineers will design a compliant, efficient production line tailored to your requirements.