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GMP process design for pharmaceutical bottles

Jul 25 , 2019

In addition to selecting reliable injection molding equipment and precision molds, pharmaceutical bottle manufacturers must systematically design the corresponding GMP specifications and process flow. The main contents include:

Main indicators: 100,000 cleanliness


GMP process design for pharmaceutical bottles

pharmaceutical packaging


Three-level filtering (fine, medium, high, top send back mode)

Air exchange times ≥ 20 times / hr

Temperature T=26-28 degrees

2, chilled water system

Temperature T=5~15 degrees, pressure p≥0.2mpa, flow rate q≥rated value

3. Cooling water system

Temperature T≤28°, pressure p≥0.2mpa, flow rate q≥rated spray, circulation system

4, compressed air system

Pressure p≥1.0mpa, flow rate q≥calibration value, configuration regulator tank, freeze dryer, secondary filtration, automatic drain valve, compressed air temperature 65 degrees <20 degrees

5, mold thermostat

Water medium mold temperature machine: working temperature tmax ≥ 120 degrees, p ≥ 0.4mpa, microprocessor or pid control

Oil medium mold temperature machine: working temperature tmax is equal to 30-300 degrees, p≥0.2mpa, pid or one-position control instrument

(Recommendation: The use of water medium mold temperature machine for the production of medicinal plastic bottles to ensure the quality of the medicine bottles and prevent leakage of oil medium)

6, mixing, feeding, crushing device

The mixing time is controllable, and the best mixing effect can not be achieved if the length is too long or too short. The feeding method is recommended to use top layer feeding or automatic vacuum feeding method, but the coloring of the concentrated masterbatch should be used to prevent the dust pollution in the workshop from exceeding the standard. The pulverizer should use a low-noise, high-efficiency rotary cutter (mainly crushing the bottle cap injection flow channel rack and a small amount of waste bottles), and the amount of returning material should be reasonable and appropriate (less than 15% wt) to prevent repeated cycle degradation. Performance, raw materials of different grades must be processed separately and cannot be mixed at will.


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