Oral Solid Dosages
Solutions conform to new GMP requirements for sample warehouse & humiture monitoring

Sample warehouse
Regulation standards
GMP2010
Article 52. Metage of preparation of raw materials usually should be weighed in specially designed weighing room.
Article 53. Dust production operation such as, dried material or sampling, weighing, blending and packaging etc. should maintain relatively negative pressure or take specific measurement to avoid dust dispersion, cross contamination and cleaning inconvenience.
Article 62. A single material sampling area should usually be designed. The air cleanliness class should agree with that of area.
Enforcement Guidelines
Sampling of raw materials, direct contact drugs with packaging material is one of the highlights of product protection. Sampling should be in a separate sampling area and the air cleanliness class should agree with production grade. If sampling has to be conducted in production area, a separate room should be designed as straight exhaust air; return air shall not be recycled.
Room with production of large quantities of dust is relatively concentrated; the central dust collection system should be established. No purification measures no recirculating air.
Humiture Monitoring System
GSP requirements must be carried out to every link of circulation computer information management. Temperature and humidity automatic monitoring system must be used at drug storage warehouse, especially highlights cold-chain management in the process of drug and vaccine transportation. It is clear that in the stored drug warehouse and transportation of refrigerated and frozen drug, device should be equipped with automatic temperature and humidity monitoring system.


Research on Warehouse temperature and humidity distribution
Making temperature/humidity profile is not a one-off job but a conforming key that work personnel organization and documented job should agree with warehouse layout change and any other significant changes of the warehouse environment due to different seasons and HVAC/R remold.
Humiture Monitoring System based on PLC.
Traditional humiture monitoring system based on PLC records and files through collected data from warehouse humidity and temperature etc. once those data exceed storage range, alarm and record.
Suitable for single building with large-scale three-dimensional library, etc.

Humiture Monitoring System based on network transmission.
Humiture Monitoring System based on network transmission records and files through collected data from warehouse humidity and temperature etc. once those data exceed storage range, alarm and record.
Suitable for distributed small and medium-sized warehouse.

Verification Test
We can provide comprehensive set of verification test and support including cold storage, refrigerator car, deepfreeze(incubator) and humiture monitoring system executed by professional engineer.

  • Warehouse Management Procedure
  • Cold-chain Management Procedure
  • Computerized warehouse logistics management program
  • Cold-chain management verification procedure
  • Computerized warehouse logistics system verification procedure
  • Other else support SOP

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如果您想进一步了解详情,请留下联络方式,我们会尽快和您联系
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