Aseptic Preparation System Solution Features:
(1) Main functions include concentrated compounding, decarbonizing filtration, diluted compounding, sterile storage, aseptic filtration, material transfer, heating/cooling, CIP/SIP and control system.
(2) KEAN designs system process and selects equipment as per product technology, URS and relevant laws and regulations. System can realize automatic control of on-line cleaning, sterilization and material transfer, etc.
(3) Piping and equipment meets requirements of GMP production, without blind pipe and dead ends. Installation of equipment and accessories facilitates disassembly, maintenance and repair.
(4) Structure of steel platform is well-designed, so it will be easy for operating and carrying out all kinds of cleaning work.
(5) Control system meets operation requirements of production process. Relevant parameters of compounding system can be monitored and recorded in real time, to ensure quality tracking and follow-up.4
(6) After detailed design and before construction, the whole system will be three-dimensional designed according to layout of field equipment.
(7) KEAN provides a full set of validation services, including risk assessment (RA), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), etc.
(8) Modular design: Compact structure, easily to operation and maintenance.
(9) All operations are controlled via a touch screen HMI and PLC controllers