Fonko International was established in 2010 to manufacture and supply quality oncology products to the world. Its state-of-the-art production machinery and strict adherence to global compliance requirements enable it to manufacture APIs assigned an Occupational Exposure Band of 5 (the highest rating possible).
Fonko regularly supplies oncology injectables and provides contract manufacturing services to global partners, including those in highly regulated markets. Its primary facility (in Cikarang, Indonesia) was designed to satisfy the GMP requirements of various regulations, such as those of the European Union, the Therapeutic Goods Administration (TGA, Australia) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
GMP Certificate for Liquid Injections
Indonesia (a member of PIC/S)
GMP Certificate for Freeze-dried Injections
Indonesia (a member of PIC/S)
Halal Assurance System Certificate
Majelis Ulama Indonesia
The facility currently has a sterile manufacturing line for liquid injections and freeze dried injections in wide-range vial sizes, with variable batch size. The manufacturing line is capable of aseptic processing in a microbiologically controlled environment, as well as terminally sterilized oncology products. By implementing a safe and efficient manufacturing process, including a rigorous quality management system, Fonko has developed a reputation for providing oncology products of uncompromising quality.
To ensure the safety of the operator, mixing vessels are integrated with containment systems that can handle high potency APIs. Mixing vessels are of variable batch size, and are capable of handling light-sensitive APIs and flammable solvents. The facility also utilises a heating – cooling system, online temperature monitoring, real-time pH monitoring, dissolved oxygen measurement, and a SCADA system.
The filling line includes rotary piston pumps as well as precision peristaltic pumps, a washing machine, a capping machine, and an external decontaminating machine. Barrier technology is used to provide an aseptic environment, ensuring product sterility and operator safety. The filling machine is equipped with a 100% check weighing and alarm system to ensure dosage accuracy. The filling line enables a wide range of vial sizes, processes and batch sizes.
The freeze dryer is connected to the filling line through an automated loading and unloading system. It is able to handle not only water-based, but also organic solvents with varying cycle durations and vial sizes. The automated loading and unloading system, with automatic row-by-row vial loading, increases efficiency and minimizes operator intervention, ensuring product sterility. It is equipped with a pre-cooling shelf to ensure the stability of temperature-sensitive products.
An automatic and continuous packaging process minimizes the risk of mix-up and increases productivity. Automatic Visual Inspection technology ensures that 100% of vials for liquid and lyophilized Injections are inspected and validated, to attain consistent quality of product. Labelling is supported with an OCR Camera to inspect each label and verify its accuracy and printing quality. The downstream machine enables automatic cartoning with a pharma-code reader, and the use of tamper-evident carton designs to prevent counterfeit.
The laboratory space is separated into 3 areas: a containment laboratory, a general chemistry laboratory, and a microbiology laboratory. The containment laboratory analyzes cytotoxic powder, and is equipped with a containment system to ensure personal protection. The general chemistry laboratory analyzes samples in liquid form or samples in closed containers, and is equipped with an autosampler instrument to reduce the analysis time for High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC). The microbiology laboratory is equipped with a sterility-testing isolator, with validated decontamination cycle and defined cycle parameters, enabling aseptic working conditions with assurance of the highest sterility. Laboratory work is concentrated in Dexa Group’s Dexa Development Center (DDC).
Sufficient storage space is supported with material handling equipment to ensure that materials and products are managed properly. The warehouse space is temperature-controlled, with a real-time monitoring and alarm system to ensure that materials and products are stored as per their requirements. The warehouse is capable of various storage conditions, including cold storage, refrigerated storage, ambient storage, flammable storage, and dedicated storage for APIs. A warehouse management system is integrated with an ERP system to ensure the accuracy of picked material.