Environmental Monitoring Solutions
Pharmaceutical Monitoring Systems
Cleanroom Management International offers complete 21 CFR part 11 compliant solutions for clean room and facility monitoring systems.
Systems with succinct, secure results
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. Monitoring of non-viable and viable particle counts, differential pressure, temperature, relative humidity and air flow, our systems deliver succinct, secure results.
GxP Compliant Computerized Systems
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.
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 (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.
Viable and non-viable environmental monitoring
The requirements for viable and non-viable environmental & process monitoring are described in section number 9 of GMP Annex-1. The number of sample locations and the physical quantities that must be monitored depend on a risk-based approach. 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 department can show that the production process is under control and complies to the requirements of GMP. The monitoring system will also help to better understand your critical processes.
Official Partner Pharmagraph® and JRI®
CMI is the official partner of Pharmagraph® with their enVigil Environmental Facility Monitoring System (FMS) software and high quality PLC-controllers like the MX6001 and MX5000 controller. CMI is also the official partner of JRI® (Jules Richard Instruments), with their new IOT monitoring solution MySirius which integrate most SPY sensors. 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.
GAMP 5 Validated Systems
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 ISPE GAMP 5 ‘A Risk-Based Approach to Compliant GxP Computerized Systems’.
Alarms and Alarm Requirements
The other next thing to consider are the possibilities to receive alarms from the system and the requirements needed to comply with the URS.
Must the alarms be visible and audible or is it sufficient to receive a text message or e-mail when an alarm is triggered?
Within what time frame must the alarm be acknowledged by a qualified user?
Do you possibly need alarm delays or do you want immediate alarms and alarm cascades to be configured?
The answers to these questions are important for us to select the best monitoring solution for our customers. We therefore have more than just one monitoring system to offer from different industry leading manufacturers.
Monitoring Applications and Features:
GxP Regulated industries
Isolators and RABS
21 CFR part 11 Compliance
Freeze dryer Monitoring
RHT Monitoring in Musea
Wired or Wireless Systems
We can offer Wireless Cloud Monitoring Systems or Wired systems with an on-premise server solution depending on the ease of installation within a building. Many different sensors can be integrated in these systems depending on the requirements of the system. Most common used sensors are temperature sensors for cold chain control, relative humidity sensors, differential pressure sensors and airborne particle counters.
Whether you are designing a new controlled environment, a new laboratory or upgrading your current sterile production area CMI offers many years of experience in designing systems for specialized applications in life science, biotech-, and industrial research/processing facilities. We take care of the complete process including documentation and qualification of the systems we supply. Our systems can be extended with smart integrated Microbial air sampling (iVAS) and TOC analysis if required.
Cleanroom & Isolator Monitoring Solutions
What our clients are saying
As CMO in the biopharmaceutical sector, Novasep Belgium pays special attention to the qualifications of production areas and equipment. For some 10 years now, CMI has been a partner we can rely on for the realisation of these operations.
Flexibility and professionalism are two of CMI’s assets.
It is always nice to work with the motivated CMI team! Everyone is very helpful, enthusiastic and they have a great sense of responsibility. They are always welcome!
CMI is a reliable and professional partner where quality and service are of paramount importance and with whom we will undoubtedly continue to work together.
I would like to thank you again in this way, I have been working here at Novartis (Alcon Couvreur NV) for 17 years. Quality and correctness are our top priorities. Nevertheless we always bring it to a succesfull conclusion, partly through your great support.