Since the first day of the foundation, the company has decided to design and construct the advanced international sewage treatment system to treat the pharmaceutical and chemical wastes, not only by obeying national laws and regulations but also by introducing the idea for the environmental protection, energy saving, and sustainable development, to balance the relationship between the economics and development.
By investing more than 15 million, the company has built the modern sewage treatment system with all imported equipment, like biological membrane, UF, RO, and ED combined technological process to treat pharmaceutical and chemical wastewater to meet the State’s discharge standards. The wastewater has been used to water lawn and trees, etc. By the technology of low temperature condensation, leaching, and adsorption, the treated waste gas contains less contaminant compared with the surrounding air background. The company also has the specialist as well as the warehouse to collect and store the hazardous waste, and entrust the licensed professional organization to dispose and destroy the wastes. In accordance with the requirements of environmental protection department strictly, the energy used in production is the clean energy.
Pursuing for the enterprise with the level two safety production standardization on May 2014, Beijing Sciecure passed the inspection by Beijing Administration of Work Safety and Beijing Safety Production Association and was awarded the title of “Beijing Safety Production Standardization Enterprise” on March, 2015.
This workshop was built on March 2012 with an area of 2000㎡, located on the centre of the first floor of the new manufacturing building. The major production is focused on the Compound Amino Acids Infusion, with the annual manufacturing capacity of 7.5 million 50ml bottles, 4.5 million 100ml bottles, 4.5 million 250ml bottles, and 2.25 million 500ml bottles. The whole production assembly is designed and assembled with all imported the-state-of-art equipment from Europe for EU and FDA pharmaceutical standards, such as the Powder Handling System (B + S), Stopper & Aluminum Cap Automatic Wash & Sterilization & Transportation System (Germany Atec), Product Final Sterilizer (Italy Fedegari), etc.
The systems in place are highly automatic, as well as controlled by Siemens MES and Production Coordination & SCADA System.
This line will be inspected by CFDA and the EU Agency in the due course.
API workshop, located at south-east of the factory site, was designed and constructed on 2012 with a total of 2420㎡ for two levels, including 550㎡ of restrictive synthesis area for cytotoxic compounds, following CFDA and EU GMP, as well as FDA cGMP requirements.
There are more synthesis production lines employing either imported or domestically madefirst-class equipment. This provides an annual production capacity of 1,000kg of general chemical synthesis and the cytotoxic production is at a kilogram level.
This workshop will be inspected by CFDA, EU, and FDA Agency in the due course.
Workshop of OSD is located on the second floor of the new manufacturing building for the main production of tablets and capsules.
The workshop is designed and constructed according to the China, and EU GMP, as well as FDA cGMP standards. All main systems of the project, such as the workshop utilities, laminar flow, granulation, blending, tableting machine, coating machine, packing line along with more than 40 sets of process equipment were imported from abroad. The installation commissioning and qualification of the air conditioning system, utilities, as well as the process equipments were completed in January 2015.
Workshop has the advanced process equipment for executing single or more complex process preparation requirement, such as Germany Glatt multifunctional fluidized bed can be used for the conventional drying, top spray granulation, and towards the end of spray coated pellets; Italian MG2 capsule filling machine can deal with the powder, granules, micro pill, or mixing all; Germany Korsch can be set for the pressed monolayer compression, double layer pellet; Advanced Mediseal aluminum-PVC packaging line and Capmatic bottling line allows for high speed and stable packaging; granulation, coating, and screen lines are equipped with CIP; capsule machine, tablet machine, and packaging lines are equipped with online tick waste, online weighing, metal detection as well as other functions, in order to ensure the quality of the products and equipment cleanliness.
The workshop will be inspected by CFDA and EU Agency in the due course.
Workshop was built in February 2003, and the comprehensive systems were rebuilt in 2013 for lyophilization, vial, small volume infusion, micro emulsion, and fat emulsion production.
With advanced equipment, both imported and domestically made, workshop was focused to the high level since the first day of its design, construction, assembly, commissioning, qualification, validation, and followed all the way through production to manufacture the high quality products to meet the new vision of CFDA GMP as well as the EU standard. By June 2015, the facilities, utilities, and equipment had completed installation commissioning and qualification, was inspected by CFDA on September, 2015, and granted the license later.
More than 60 sets of process equipment were either imported or domestically made, such as VHP generator (Bioquell), high speed shearing machine (IKV), high pressure homogenizer (SPX), stopper washing machine (Fedegari) to satisfy all process requirements for the products mentioned before. Ingenious invention (one washing & tunnel oven assembly with two independent filling & stoppering machines for either lyophilization or capping) allows for flexible combination of production arrangements
Besides modern and advanced process equipment, simplified team will allow staff to become familiar with all positions in the workshop and become cultivate talents in pharmaceutical industry.
Workshop was built in February 2003, and the comprehensive systems were rebuilt in 2013 for the small volume sterile injection in accordance with the CFDA and EU GMP standards. Through the constant and advanced technical innovation, it has been inspected by CFDA on January 2014.
With the advanced equipment, both imported and domestic, workshop was focused to the high level since the first day of design, construction, assembly, commissioning, qualification, validation, and followed production to manufacture the high quality products to meet the new vision of CFDA GMP as well as the EU standard. it was passed new version GMP inspection by CFDA on January 2014.
Besides the hardware, the documentation systems as well as the trainings thereupon have been improved, including process procedures, SOP, verification, technical standards, and skill trainings. By the internal, risk, and cost control, we have eliminated the tedious work, and completed the production more efficient.
