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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.
(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
( Clean Room Air Cleanliness Classifications and Criteria)：
|Maximum concentration||Bacteriological control|
|limits(particles/m3) for particles|
|≥particles size shown||Floating bacteria||Settling microbe||rate|
|≥0.5µm||≥5µm||per m3||per dish||(Volume/h)|
(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％
Room illumination is higher than or equal to 300Lux.
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：
Inner of Glass Bottle / Bacteriological control:
Take the samples from the shrink wrap, (including the following tests)：
ABC GLASS BOTTLE Palletization:
Shrink wrap for bottles
Pallet label which certifies the
handling in clean room.
Welcome any order for OEM AND ODM.
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.