2013年8月29日星期四

dental machine status abroad


We developed countries tableting machine with compression technology gap is widening, high yield, airtight, modular, automated, large-scale and advanced

Detection technology is the most important foreign tableting machine technology development direction. Advanced tableting machine base in Europe, such as Germany FETTE, KORSCH, UK MANESTY, Billy

When COURTOY, USA STOKES so on. High degree of automation of its products, in compliance with FDA requirements and 21CFRPART11 requirements.

(1) high speed, high yield. dental hand piece High speed and high output was tableting machine manufacturers over the years has always been the goal, the main tableting machine manufacturers already have hourly output

Reach 1 million tableting machine. If Manestry produced Xpress700 type tableting machine yield amounted to 1,000,000; Korsch XL800 type produced by tableting machine

Maximum output reached 1.02 million / h; Courtoy produced ModulD type tableting machine maximum output reached 1.07 million / h; Fette 4090i produced the highest type tableting machine

Production reached 1.5 million / h. Its production is much higher than domestic production of tablet presses, tablet confidential domestic production to catch up in terms of speed than abroad, you need to create a tabletting machine design

New processing technology, automatic control and other aspects have made great progress. Tabletting machine

(2) tabletting process link airtight and flow, logistics isolation. Foreign tableting machine input and output is very good sealing, to minimize cross-contamination

. Granules for tableting barrel and closed via a closed conveyor system into the hopper, tabletting process to take effective measures to prevent dust emissions and particulate stratification, pressure is good

Tablets through sieve, the film detection, metal detection, etc. into the packaging process, the whole process was very confined. While most domestic pressure tableting machine process is open,

Or is not completely closed, fracture resulting tableting process between dust. With the further implementation of GMP in the tabletting process link airtight and flow, logistics

Isolation becomes particularly important, this is our design and manufacture equipment must have the basic functions.

(3) CIP. CIP (cleaning in place) tableting machine, enabling users to significantly reduce the cost of equipment. Improve the tableting machine cleaning function, in addition to the design

Fully consider the various parts of the cleaning, the tableting machine disassembly cleaning function is to emphasize that only convenient and quick removal, in order to ensure the thoroughness of cleaning.

(4) 21CFRPart11 (electronic records and electronic signatures) in tableting machine application. August 20, 1997, FDA issued 21CFR11 Part 6 "e-

Records, electronic signatures (ER / ES) with the relevant regulations came into force. Of electronic signatures and electronic records, the present regulations are enforced, the purpose of this Ordinance

Of that for pharmaceutical products and food processing to facilitate the introduction of electronic technology. It can provide a suitable and practical guidelines, as set forth

What to do in the past through the electronic form in writing task. Refers to the electronic record as text, graphics, data, audio, icon, or other by scoring

Computer systems to create, modify, maintain, archive, collect or distribute information in digital form between the expression of any combination. Electronic signature refers performed by individuals

, Adopted or authorized, and after a computer data compilation of any symbol or series, which conform with personal handwritten signature has the same legal effect.

21CFRPart11 technology in the tablet press on the application, making the tableting machine with device diagnostics logging, logging accidents and alert notification log. These dental instruments electronic records

And electronic signatures are detailed records on a variety of operational data, accident data. Compliance with safety access control, requires a user name and password to enter the operation. All numbers

According to the use of the electronic signature function, including the operator name, date, time, serial number, problems, solutions, condition data. All raw data are not

Can be artificially modified to ensure the reliability and authenticity. The presence of these systems and users will automatically log into the whole "traces review" folder. This

Some security attribute data format "to ensure data changes are under the control of the overall examination into the tablet press line. Domestic in this area is just beginning.

(5) connected with the entire production line control technology. Put a tableting machine can be connected to a production line in Germany and the UK tableting machine have this feature

. It has a beginning, end, and speed adjustment function. Use this option to function reliably, automatic production line with other devices, such as sieve, suction

Dust, testing, transportation, bottled, etc. are connected together, synchronization is complete pills suppress production tasks. Meanwhile, the external device also uses a different means of monitoring,

Provides high security and reliability of energy. Using the line detector can suppress tablets clear burrs, remove dust; vacuum monitoring function is the use of traffic

Monitor regularly the specified location on the suction tube suction pressure testing. Continuously set and actual values ​​of the comparison, if the detector 10s in the suction tube

The suction pressure is not detected (no flow), the pressure plate machine that is a fault alarm and stop operation. This feature is to maximize the protection of the production can be

Reliability, the tablet can be continuously remove the dust suppression of the production process. And the entire production line to connect the tablet is a tablet control technology production control of new technologies, is the future

Trends. This technology in China has just started.

(6) tableting machine remote monitoring and remote diagnostic system. With networking, broadband network, virtual, etc. The rapid development of high-tech computer equipment remote monitoring and

Remote diagnostics technology is also increasingly emerging. Computer-controlled pharmaceutical tableting machine began extensive application of remote monitoring and remote diagnostics technology in the industry has a tableting machine

Useless. , Advanced in developed countries has generally been on the tableting machine with remote monitoring and remote diagnostics. In order to establish such a system is also implemented technical support

Center (service side) and tableting machine side (user) dialogue through the Internet network, enabling service side can understand the user via the Internet in different places tableting machine out

The fault lies now, and tabletting machine working status of the instruction is executed, and then on the tableting machine fault judgment and propose possible solutions. By a tabletting machine

Remote monitoring and remote diagnostics system establishment, real-time troubleshooting, greatly improving the tableting machine manufacturer's service response capacity and speed, but also

Improve the economic efficiency of enterprises. Tabletting machine remote monitoring and remote diagnostics system should include staffing, network construction, hardware and software selection, etc.,

Respectively, to complete failure of the monitoring, analysis, feedback, and real-time resolution services issued these processes in order to ensure the effective operation of the entire system.

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