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Pharscin Pharma has 11advanced production lines. Tablet, Capsule and Granule production lines Pharscin Pharma had its tablets, capsules and granules production lines first passed the GMP certification of NMPA(former CFDA) in 2001, and then passed the GMP review certification with the expiration of 5 years in 2006. It also passed the 2010 GMP certification with the expiration of 5 years in 2011 and 2017 respectively. The three production lines are designed and built in strict compliance with the technological process of oral solid preparation and Class D clean zone requirements. Thanks to its advanced equipment and high degree of automation, "four advanced production technologies" , which refer to production process control, delivery by pipeline, automatic detection and mechanic packaging, have been truly realized. As a result, the quality of products is effectively ensured. Among equipment in this factory, ultra-low temperature crusher, high-efficiency wet granulator, high-efficiency boiling granulator, vacuum rotary dryer, automatic dust-free tablet press, automatic particle packaging machine, automatic aluminum plastic packaging machine, automatic double aluminum packaging machine and fully automatic bottling production line are all international and domestic leading equipment. The application of ultrafine low-temperature pulverization technology has improved the dissolution effect and bioavailability, taking product quality to a new high. The annual production capacity of the tablet production line is 2 billion, the annual production capacity of the capsules production line is 1 billion, and the annual production capacity of the granule production line is 50 million bags. All kinds of verification and daily monitoring in the production workshop are strictly implemented in accordance with the provisions, effectively ensuring the stability, uniformity and control of the products produced by the production line. Soft capsules and powder production line Pharscin Pharma had its capsules and powder production lines first passed the GMP certification of NMPA(former CFDA) in 2004, and the soft capsules production line filled in the blank of the soft capsules production line in Chongqing at that time. These two production lines passed the 5-year GMP review and certification in 2009, and passed the 2010 GMP certification in 2014. The two production lines are designed and built in strict compliance with the technological process of oral solid preparation and Class D clean zone requirements. Thanks to its advanced equipment and high degree of automation, "four advanced production technologies" , which refer to production process control, delivery by pipeline, automatic detection and mechanic packaging, have been truly realized. As a result, the quality of products is effectively ensured. Among equipment in this factory, fully automatic pill-pressing machine, automatic aluminum-plastic packaging machine, fully automatic bottling production line, cryogenic crushing equipment and fully automatic low temperature granular packaging machine are cutting edge at home and abroad. The annual production capacity of soft capsules production line is 1 billion, while the annual production capacity of powder production line is 60 million. The verification and daily monitoring of the workshop are carried out by strictly complying with relevant provisions in order to effectively ensure the products produced through production line are stable, homogeneous and controllable. Production lines of powder-injection, freeze-dried powder injection and small-volume injection The production lines of powder-injection, freeze-dried powder injection and small-volume injection of Pharscin Pharma were at first certified to GMP by the NMPA(former CFDA) in 2004. The said production lines were successfully certified to GMP again in 2009 when its first certification was expired 5 years later and the GMP of 2010 Version in 2013. These three production lines are designed by strictly complying with the technological process of sterile preparation and Class A, B, C, D clean zone requirements. All exposed location of supplies, rubber plug, bottles and containers, etc. are protected with the Class A laminar flow hoods, which have effectively prevented pollution and cross contamination. Thanks to its advanced equipment and high degree of automation, "four advanced production technologies" , which refer to production process control, delivery by pipeline, automatic detection and mechanic packaging, have been truly realized. As a result, the quality of products is effectively ensured. Among equipment in this company, proportioning system, fully automatic ultrasonic bottle washer, fully automatic rubber plug cleaner, fully automatic aseptic sorting machine, fully automatic aseptic filling machine, vacuum freeze dryer, fully automatic drawing filler, fully automatic water bath sterilization and leak detection equipment, etc. are cutting edge at home and abroad. The annual production capacity of powder-injections production line is 100 million. The annual production capacity of freeze-dried powder injections is 10 million. The annual production capacity of small-volume injection is 500 million. The verification and daily monitoring of all production lines are carried out by strictly complying with relevant provisions in order to effectively ensure the products produced through production line are stable, homogeneous and controllable. Production line of traditional Chinese medicine extracting Production line of extracting traditional Chinese medicine in Pharscin Pharma was carried out by the "Chongqing Municipal Modern Engineering and Research Center for Traditional Chinese Medicine" of "National Modern Engineering Technology Center for Traditional Chinese Medicine" . It was first certified to GMP by the NMPA(former CFDA) in 2001, and was successfully certified to GMP again in 2006 when its first certification was expired 5 years later, the GMP of 2010 Version in 2011, and was successfully certified to GMP of 2010 Version in 2017 when its former certification was expired 5 years later. The production line is designed and built in strict compliance with the technological process of oral solid preparation and Class D clean zone requirements. Thanks to its advanced equipment and high degree of automation, "four advanced production technologies" , which refer to production process control, delivery by pipeline, automatic detection and mechanic packaging, have been truly realized. As a result, the quality of products is effectively ensured. Among its equipment, CO2 supercritical extraction equipment, ultrasound oscillation extraction equipment, macroporous resin adsorption coupling unit, microwave vacuum decompression drying equipment, spray dryer, etc. are cutting edge at home and abroad. Many extraction and purification methods such as aqueous extract, alcohol sedimentation, CO2 supercritical extraction, ultrasound oscillation extraction and macroreticular adsorbent are applied. These methods have played an important role in improving traditional production method of traditional Chinese medicine and quality of products, advocating technical innovation of traditional Chinese medicine and building a quintessence brand of traditional Chinese medicine. The annual production capacity of this production line is 1000 tons. The verification and daily monitoring of all workshops are carried out by strictly complying with relevant provisions in order to effectively ensure the products produced through production line are stable, homogeneous and controllable. Comprehensive automation has been adopted to the newly-built Phase Ⅴproduction line. Production line of chemical raw medicine Production line of APIs in Pharscin Pharma was first certified to GMP by NMPA(former CFDA) in 2001, and was successfully certified to GMP again in 2006 when its former certification was expired 5 years later, and was successfully certified to GMP of 2010 Version in 2011, and was successfully certified to GMP of 2010 Version in 2017 when its former certification was expired 5 years later. The production line is designed and built in strict compliance with the technological process of oral preparation (crude drug) and Class D clean zone requirements. Thanks to its advanced equipment and high degree of automation, "four advanced production technologies" , which refer to production process control, delivery by pipeline, automatic detection and mechanic packaging, have been truly realized. As a result, the quality of products is effectively ensured. Among equipment in this company, ultra-low temperature crusher and high-efficiency boiling dryer are cutting edge at home and abroad. The application of ultrafine low-temperature pulverization technology has improved the dissolution effect and bioavailability, taking product quality to a new high. The annual production capacity of this production line is 200 tons. The verification and daily monitoring of all workshops are carried out by strictly complying with relevant provisions in order to effectively ensure the products produced through production line are stable, homogeneous and controllable. Synthetic production line Synthetic production line in Pharscin Pharma was newly built in 2012, which was successfully certified to GMP of 2010 Version in 2017. This production line is mainly used to produce the newly researched and developed high-tech APIs. This production line is designed and built by strictly complying with relevant requirements of oral preparation (APIs) and Class D clean zone requirements. Advanced international concept is also applied to the whole process of this production line. With its advanced equipment and high degree of automation, the new high efficiency production featured production and operation process control, supplies delivery by pipeline and automatic detection of products have been realized. The daily management of whole production line is carried out by strictly referring to GMP of 2010 Version. Therefore, the research and development of drugs is more scientific and controllable, which in fact helps Pharscin Pharma to move forward more successfully. Phase V Newly-built CMP Manufacturing base At present, with the increasing development of the company, a new manufacturing base of Pharscin Pharma occupied more than 160 mu is under construction. Based on original 11 production lines, a production line for Chinese herbal slices, animal house and overhead automated warehouse are newly added. The new production base will be designed and built in strict compliance with requirements of EMA and FDA. An independent air conditioning purification system is adopted to strictly separate chemical drug from traditional Chinese medicine. The international first-class production equipment is used in the newly built production base. International advanced technologies such as automatic appliance cleaning system, automatic weighing and batching system, automatic input and output system, isolation system, on-line monitoring system, intelligent robot packing and palletizing system and sterilization system of space vaporized hydrogen peroxide, dustless intelligent conveying system for material in workshop, intelligent material transfer system for workshop and warehouse are also applied to this production base. As a result, digitization, automation and intelligent manufacturing are actually realized in full. |