{"id":1593,"date":"2020-09-14T07:15:35","date_gmt":"2020-09-14T07:15:35","guid":{"rendered":"https:\/\/cleanroom.questo.nl\/?page_id=1593"},"modified":"2021-03-26T10:39:44","modified_gmt":"2021-03-26T10:39:44","slug":"monitoring","status":"publish","type":"page","link":"https:\/\/www.cmitest.nl\/fr\/monitoring\/","title":{"rendered":"Monitoring"},"content":{"rendered":"
<\/div>
<\/div>

Monitoring<\/h1>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

Environmental Monitoring Solutions<\/h1>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

Pharmaceutical Monitoring Systems<\/h4>\n<\/div><\/div>
<\/div><\/div>
Cleanroom Management International offers complete 21 CFR part 11 compliant solutions for clean room and facility monitoring systems.<\/h5>\n<\/div><\/div>
\"\"<\/div><\/div><\/div><\/div><\/div><\/div>
Systems with succinct, secure results<\/h6>\n<\/div><\/div>
From supply of sensors, through to installation, system qualification, training and calibration, we work with you at every stage to ensure that systems are delivered on time and to specification.\u00a0Monitoring of non-viable and viable particle counts, differential pressure, temperature, relative humidity and air flow, our systems deliver succinct, secure results.<\/h5>\n<\/div><\/div><\/div><\/div><\/div><\/div>
GxP Compliant Computerized Systems<\/h6>\n<\/div><\/div>
Monitoring systems are widely used within the cleanroom regulated industries like the pharmaceutical industry, manufacturing of medical devices and semiconductor manufacturing. Monitoring systems designed for the pharmaceutical industry must comply with GMP Annex-1 for the manufacture of Sterile Medicinal Products.<\/strong><\/h5>\n
Depending on the application of our customers and their requirements we select the best monitoring solution together with you. Whether you need to fit a monitoring system into an existing building, a new building , an isolator or a filling line, the requirements will be different for every single system. To find the best possible monitoring solution together with our customers we always start with the URS<\/strong> (user requirement specification). If you need help writing your URS document our knowledgeable team from the Commissioning and Qualification department can assist you in every stap.<\/h5>\n<\/div><\/div><\/div><\/div><\/div><\/div>
Viable and non-viable environmental monitoring<\/h6>\n<\/div><\/div>
The requirements for viable and non-viable environmental & process monitoring are described in section number 9 of GMP Annex-1<\/span>. The number of sample locations and the physical quantities that must be monitored depend on a risk-based approach.\u00a0 In many cases the pressure hierarchy must be monitored as well next to the viable and non-viable counts. If the product would also be temperature sensitive or the stability would be impacted by the relative humidity these parameters must also be monitored. It is important that the Quality Control<\/strong> department can show that the production process is under control<\/strong> and complies to the requirements of GMP. The monitoring system will also help to better understand your critical processes.<\/h5>\n<\/div><\/div><\/div><\/div><\/div><\/div>
Official Partner Pharmagraph\u00ae<\/sup> and JRI\u00ae<\/sup><\/h6>\n<\/div><\/div>
CMI is the official partner of Pharmagraph\u00ae<\/sup> with their enVigil E<\/span>nvironmental F<\/span>acility M<\/span>onitoring S<\/span>ystem (FMS) software and high quality PLC-controllers like the MX6001 and MX5000 controller. CMI is also the official partner of JRI\u00ae<\/sup> (Jules Richard Instruments), with their new IOT monitoring solution MySirius <\/strong>which integrate most SPY sensors<\/strong>. Both systems can be fully validated to the ISPE GAMP 5 Guidelines. For less demanding monitoring requirements we offer datalogging systems with local logging or cloud based logging via WiFi, for these products we refer to datalogging webpage<\/strong><\/a>.<\/h5>\n<\/div><\/div><\/div><\/div><\/div><\/div>
\"\"<\/div>
Envigil FMS version 5<\/div><\/div><\/div>
GAMP 5 Validated Systems<\/h6>\n<\/div><\/div>
Once the system has been documented and installed it must be qualified depending on the requirements as described in the URS. The qualification process consists of validation documentation and the on-site qualification of the system. We have the ability to fully validate your system according to the\u00a0ISPE GAMP 5 \u2018A Risk-Based Approach to Compliant GxP Computerized Systems\u2019<\/strong>.<\/h5>\n<\/div><\/div><\/div><\/div><\/div><\/div>
\"\"<\/a>
Alarm Display Envigil FMS<\/div>
AN1440<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div><\/div>
\"\"<\/div>
Alarm Beacon Stack<\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Alarms and Alarm Requirements<\/h6>\n<\/div><\/div>
The other next thing to consider are the possibilities to receive alarms from the system and the requirements needed to comply with the URS.<\/h5>\n