General situation of small-capacity injection production workshop
The production workshop of small-capacity injection (glass ampoule and plastic ampoule) was designed by Shanxi Medical Planning Research Center in May 2009. The construction area is 2,488.8m2, including a 280m2 clean area of one hundred thousand levels, a 602.6m2 clean area of ten thousand levels; a hundred-level 4.5m2 laminar flow under environment of ten thousand levels. The production workshop applies independent air cleaning system of which the blower has a rated blowing capacity of 3,5000m3/h. The production area contains “clean production area of ten thousand levels (parts of a hundred levels), general production area”; the internal decoration materials are all metal color plate of 5~10cm; the ground of clean area is “epoxy resin self-leveling” ground; lighting lamps and lanterns is purified fixture lamp for specific use; floor drain is double water seal. The air cleaning system is in accordance with design and production process requirement through verification, which accords with design and production process requirement. At the same time, documents are formulated requesting a regular examination of “suspended particles, colony forming units, temperature and humidity, differential pressure, air speed and ventilation rate” in its clean area by QA department.
The various products worked by this workshop have complete process specification. And it also formulates operational and management documents for production, quality and so on. The process layout of production line is reasonable; people and products will not intersect. The workshop owns advanced production equipment, high auto-regulation, key process and operational procedures. Major production equipment are under examination and will be put into use after they are qualified.
The workshop has a fixed number of employees which is 46. There’re 1 workshop director and 1 deputy director, both graduating from medicine related majors and possessing relevant job titles. The workshop consists of 9 group branches, including “dosage, injection molding, blown bottle, purging-packing-welding, sterilization, light inspection, packing and water process”. There are 9 technical staff in the workshop which is 19.1% of the total number of employees. Most employees have production experience for years, and possess high level of expertise. They can ensure the organizing production according to GMP requirements.