Mercian uses the Part 11-compliant DX200P Paperless Recorder in its pharmaceutical manufacturing works.
Mercian's Yatsushiro factory is located in Yatsushiro City, Kumamoto Prefecture, and is also known for its "Hakusui" premium shochu (distilled spirits) made from water from Minami-aso village's Ｓhirakawa spring. At the Yatsushiro factory, Mercian operates four major businesses: the alcoholic beverage manufacturing division that produces "Hakusui" premium shochu, the Alcohol Manufacturing Division, Pharmaceutical Manufacturing Division, and the Feed Manufacturing Division.
We visited Mr. Nomura of the Facilities Management section who is in charge of measurement in the overall factory. At Mercian's pharmaceutical manufacturing operations we discovered how they are using the DX200P Paperless Recorder (compliant with electronic recording standard 21 CFR Part 11) for recording of temperature and degree of vacuum, and how they are using the YS80 series SLPC Style E single loop controller for boiler control.
Mr. Nomura: "We searched for a paperless recorder, but we needed one that supported Part 11 because of our pharmaceutical operations. We decided on the DX200P because it includes all the functions required by Part 11, such as prevention of data tampering and support for electronic signatures." The DX200P helps users achieve a high level of security by saving data in binary. Additionally, it supports electronic recording standards through batch and login functions
Mr. Nomura: "When we were using paper, sometimes we would not notice chart paper outages, and data would never get recorded. With the DX200P, we don't have to worry about paper running out, and we can be certain that we're acquiring the data. Really, being able to save data electronically on the PC is a huge improvement in efficiency over recording to paper. Another convenient point is that we no longer have to replace, store, and otherwise manage stocks of paper and ink ribbons. It's also very helpful that we can connect to the corporate network and perform the monitoring from a PC. And the networking function is a big advantage because in the pharmaceutical manufacturing environment, you have to change clothes every time you go into the lab." Using the networking functions of the DX200P main unit and the included DAQSIGNIN software program, it is easy to monitor data or change settings remotely. Also, with the optional remote control, you can control the system remotely from outside the clean room.
Mr. Nomura: "When an abnormality occurs, alarm information can be sent via e-mail allowing the person in charge to take care of the situation immediately."
Also, the YS80 series single loop controller is used even in boilers for control of steam pressure and flow.
Mercian Corp. is also using the UT550 Digital Indicating Controller for temperature control in its pharmaceutical manufacturing processes.
Customer Introduction
MERCIAN CORPORATION
http://www.mercian.co.jp/e/index.html
Mr. Nomura
Facilities Management Section,
Yatsushiro Factory
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