Team and Facilities
Our production team in Jingmen stands ready to produce key intermediates and APIs from laboratory scale to hundreds of kilograms. In 2022, our capacity will expand to include manufacturing scale.
Our pilot plant operates 24 hours per day, 5 days a week, and we have the flexibility to add weekend shifts when needed.
We are currently operating in Building 102 with 36 reactors, 30 liters to 500 liters, in 7 independent reactor suites. All reactor suites can handle temperatures of -80°C to 260°C with independent TCU systems.
Quality Control
“Quality Always” is a concept that is encoded in our company’s DNA and expressed through the continuous improvement of our working methods. At Hiray, we consistently explore the best possible synthetic route and impurity-control strategy from end to end. Our management team has rich industry experience, and our staff are highly trained. Through our training system, which combines internal and external training, the quality awareness and operation skills of all employees has been continuously improved.
We always pursue quality because that’s how we ensure our products better serve patients. Whether through management structure, training systems, or process design, we continuously strive to improve quality to satisfy customers and benefit patients.
Cayden Luo, VP Quality
Our parent company’s thirty years’ experience producing injectable medicines has taught us the importance of investing in rigorous quality control measures. Hiray’s team of scientists provide a wide range of services using the latest technology with full documentation to support regulatory application submission.
Our pilot plant facility QC lab is designed for 88 Waters®-brand HPLC systems and 10 GC systems in addition to IR and UV analyses. Furthermore, we are equipped for atomic spectroscopy using Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES). We can provide method creation and validation service in compliance with cGMP and FDA standards. Product shipments are analyzed to ensure they are free of aerobic bacteria, mold and yeast, E. coli, and endotoxin. All our QC software includes audit trail features to ensure compliance with regulatory requirements.
Central Control Room
Our pilot-plant production facility is equipped with a Siemens Distributed Control System (DCS) and Gas Detection System (GDS), and an ABB Safety Instrumented System (SIS) all hardwired to our Central Control Building to protect lives, and ensure safety, quality, and on-time delivery.
Hydrogenation Reaction Suite
High-Pressure Hydrogenations up to 10Mpa
Building 102: 2 Reactors: 300-L Hastelloy and 500-L Stainless Steel
Building 103: 2 Reactors: 3,000-L Hastelloy and 1,000-L Stainless Steel
Clean Areas
Buildings 102 and 103 are each equipped with two class-D clean rooms, complete with reactors, centrifuges, filter dryers, double cone and oven dryers, ultra-fine jet mill, and mixing machines. Engineering measures such as independent HVAC, ventilation system, and ultraviolet disinfection have been put in place to guarantee the proper humidity and pressure and avoid cross-contamination.
Building 103
Manufacturing-Scale Production Facility: 69 reactors from 500L to 10,000L for a total of 15 independent reactor suites.
Expected to be online in November 2022
103 EQUIPMENT LIST