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ASME-BPE.PIC / S piping engineering/ Pure water/,Water for Injection/ Eye ointment, eye drops, machinery manufacturing equipment / Magnetic stirring


 

■ Machinery Introduction:
  With Taiwan pharmaceutical quality and international standards, to complete the implementation of more stringent international PIC / S GMP pharmaceutical standards. According to pharmaceutical Good Manufacturing Practices regulations, in order to avoid microbiological contamination by drugs, Provide for complete sterilization and aseptic operation mode, the mechanical equipment planning CIP cleaning and SIP sterilization for the whole. So that it can comply with current Good Pharmaceutical Manufacturing Practice stake provisions enacted by the Department of Health.


■ Mechanical features:
1.
The overall manufacturing machinery and equipment planning based on FDA, PIC / S GMP Guide Specification Manufacturing.
2.
Ensure compliance with the sterile efficiency requirements, machinery and equipment within the system, including the carcass, piping, pumps, blades, no dead ends of the whole production line cleaning CIP cleaning cycles, SIP sterilization and disinfection.
3.
CIP / SIP systems, with high efficiency, energy saving, safety, ease of operation of the properties, the use of PLC and man-machine interface, the whole record pressure CIP / SIP process, temperature, time, and follow customer demand set cleaning, sterilization program.
4.
PLC and man-machine interface, operating system, stability control, measurement precision, so that the system can indeed produce a steady lead to the desired effect of a high standard.
5.
For sterile drug, using a magnetic stirrer, bottom mounting, no mechanical seal design, no residue sterile way to eliminate the risk of cross-contamination.
6.
The contents of the contact surface are SUS316L, and follow customer demand for EP carcass do Electropolishing and Passivation process.
7.
Allow customers easy to use mechanical equipment, DQ / IQ / OQ / PQ identified, along with DQ / IQ / OQ / PQ documents and operating instructions.
8.
The machine contact with raw materials and surface appearance of the machine reached polish # 500 or more, for machine cleaning and maintenance have excellent efficiency and randomly attach proof polishing.
9.
Operation process automation design, control interface, digital display of the table, in line with the annual verification, calibration standards, simple operation, easy maintenance, no need for complex operation.

 

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