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China Pharmaceutical Glass Bottle manufacturer
XIAMEN ABC PACKING CO.,LTD

MORE THAN 10 YEARS OEM&ODM IN GLASS BOTTLE PACKING BUSINESS LINE

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XIAMEN ABC PACKING CO.,LTD Factory Tour

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  • Production Line

    ABC GLASS WORKSHOP BRIFE:

    The areas of 674m2 workshop, which has been tested by National Pharmaceutical Packaging Materials Testing Center  in accordance with ISO 8 Class, and certified as 100000 Class.

     

    In addition, we are fully aware of the importance of standardized management of production and introduced the GMP production management philosophy into the daily production. And the company

     

    has established complete SOP documents and quality management system and has passed the ISO9001 and ISO15378 which ensure the effective management of the product quality and traceability.

     

    XIAMEN ABC PACKING CO.,LTD

     

     

     (Clean Room Control Standard) :

     

    100% of type III amber syrup bottles manufactured in clean environment, the clean room meet the following criteria:

     

    ISO14664-1:1999 ISO 8 Class

     

    Equal to Previous US FS 209E 100000 Class

     

    SFDA “Direct Contact Drug Packaging Material and

     

    Container Management Regulation“ 100000 Class

     

    XIAMEN ABC PACKING CO.,LTD

     

    ( Clean Room Air Cleanliness Classifications and Criteria)

     

      Maximum concentration Bacteriological control  
    limits(particles/m3) for particles      
        Air renewal
     
    Class          
      ≥particles size shown Floating bacteria Settling microbe rate
               
      ≥0.5µm ≥5µm per m3 per dish (Volume/h)
               
    100000 3,500,000 20,000 500 10 ≥15
               

     

    XIAMEN ABC PACKING CO.,LTDXIAMEN ABC PACKING CO.,LTD

    (Differential Pressure) : 

     

    Differential pressure between clean production areas and adjacent areas were measured, the clean production area has adequate positive pressure (10

     

    Pa) against to adjacent different cleanliness areas, and has positive pressure (5 Pa) against to the same cleanliness areas.

     

    (Humidity and Temperature) : 

     

    The relative humidity and temperature of clean room should be adapted to pharma-packaging production. If no special requirements, The temperature should be controlled at 18-26℃, relative humidity up to 45~65%

     

     

    Lighting Brightness): 

     

    Room illumination is higher than or equal to 300Lux.

     

    XIAMEN ABC PACKING CO.,LTD

     

    Clean Room / Particle control:

     

    Monitoring Frequency for control area :Quarterly 

     

    Monitoring Frequency for inner of bottle :Quarterly 

     

     

    (Clean Room and Products Quality)/Clean Room / Bacteriological control:

     

    In clean room,  including the following tests:

     

    Floating Bacteria;

     

    Settling Microbe;

     

    Monitoring Frequency

     

    XIAMEN ABC PACKING CO.,LTD

     

    Inner of Glass Bottle / Bacteriological control:

     

    Take the samples from the shrink wrap, (including the following tests):

     

    Floating Bacteria;

     

    Settling Microbe;

     

    Monitoring Frequency

     

    ABC GLASS BOTTLE Palletization:

     

    Class 100000

     

    Shrink wrap for bottles

     

    Pallet label which certifies the

     

    handling in clean room.

     

    XIAMEN ABC PACKING CO.,LTD

     

  • OEM/ODM

    Welcome any order for OEM AND ODM. 

  • R&D

    ABC has established complete SOP documents and quality management system and has passed the ISO9001 and ISO15378 which ensure the effective management of the product quality and traceability.

Contact Details
XIAMEN ABC PACKING CO.,LTD

Contact Person: Mr. Luis

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XIAMEN ABC PACKING CO.,LTD
Room 1201A, Alishan North Building, XIamen, Fujian, China
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