The company has a strict quality assurance system, and achieved the certification of ISO9001: 2015 quality management system. It has built the only GMP purification workshop for pharmaceutical packaging materials and containers in China to provide packaging for pharmaceutical manufacturers.
The production purification workshop of pharmaceutical packaging materials and containers is in strict accordance with GMP standards, with constant temperature and humidity, the temperature control requirements for 18℃-28℃, and the relative humidity control requirements for 45-65%. The pressure difference between clean room and non clean room should be ≥10 Pa, the static pressure difference between adjacent rooms with different clean levels should be positive pressure, and the pressure difference between people flow and logistics channels should gradually increase from the outside to the inside. The dust particles ≥ 0.5um shall be no more than 3,500,000 pcs / m³, and the dust particles ≥5um shall be no more than 20,000 pcs / m³. And it is required that there should be no more than 10 settling bacteria / dishes.
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