Cybersecurity issues in the pharmaceutical industry
Interoperability and threats The industry is modernizing by adopting more efficient and accurate sensors. This modernization is also accompanied by increasingly connected and interoperable systems, leading to better integration of these systems into business processes and, at the same time, to gains in efficiency and better cost management. But this interconnection with IT information systems, […]
Critical Environmental Monitoring: Focus on Particle Counting
Clean rooms The clean rooms, delimited spaces within which the dust classes, temperature, hygrometry and pressures are known and controlled, allow operators to move and handle products sensitive to contamination. Clean rooms are used in areas sensitive to environmental contamination such as biotechnologies, for the preparation of sterile pharmaceutical products or in hospitals, for operating […]
Evolution of the environmental monitoring system in a BpX context
When choosing the installation of an environmental monitoring system (EMS), the analysis often focuses on budgetary aspects, regulatory compliance, data security, alarm notification and editable reports. But another important aspect often set aside concerns scalability and flexibility. Although monitoring requirements may be limited initially, changes in the specifications or in the monitored activity may require […]
IVTracer – Climatic chamber monitoring
Climatic chambers, cryogenic equipment, ovens, freezers, refrigerators, used in a pharmaceutical environment require precise monitoring of temperature conditions. The temperature probes generally used allow to follow with a good accuracy the temperatures ranging from -200 ° C. to + 100 ° C. The most widely used technology today is the combination of a Platinum Resistance Thermometer […]
Monitoring Of A Water Purified Distribution Loop
Water is the most used utility in the pharmaceutical industry and mainly when preparing the vast majority of drugs. Different grades of water based on chemical and microbiological purity are required depending on the type of manufacture. There are 3 different water qualities in the pharmaceutical industry: Purified Water (PW), which is intended for the preparation […]
FMS Cleanroom Monitoring – GMP Compliant
Cleanrooms are classified with different critical parameters. The most important is the number of particles per cubic meter/air volume unity. ISO 14644-11 is the standard used and expressed in cubic meters which were formerly standard US FED STD 209. IVTracer is the perfect solution for monitoring and tracking every parameter in a wide range of critical […]
Is BMS (Building Management System) an appropriate response to the requirements of GMP monitoring ?
During our missions, we are often exchanging with our industrial clients on the appropriateness of using a BMS to set up a monitoring system meeting the GMP requirements 21 CFR Part 11. It is not enough to measure ! Beyond measure, many questions must be asked. It is particularly necessary to guarantee: Secure storage of […]
Automated measurements in controlled area (GMP)
The IVTracer software integrates measurements of air or water quality, temperature, pressure, hygrometry The solution is designed and developed entirely by NetCeler and can be installed on existing sensors or PLCs. Simple to use, this complete solution is quick and efficient to use. IVTracer is the solution for monitoring and tracing all critical parameters in […]
IVTracer – The solution for GMP Environmental Monitoring
To see the video Created in 2000, IVTracer is the monitoring solution for monitoring and tracing all critical parameters in the most extreme environments. Environmental monitoring in the pharmaceutical industry is one of NetCeler’s areas of expertise, with its product IVTracer. IVTracer is built according to a specific architecture to ensure the security of the […]
GMP – Monitoring of particle counters
A particle counter makes it possible to count the number of particles in a given volume and to classify them according to their size. There are several types of airborne particle counters: so-called “fixed” or “on-line” counters, whose role is to carry out reliable and accurate continuous monitoring of particles at a given location (e.g. […]
Environmental monitoring in clean rooms
The clean rooms, delimited spaces within which the dust classes, temperature, hygrometry and pressures are known and controlled, allow operators to evolve and handle products sensitive to contamination. Clean rooms are used in areas sensitive to environmental contamination such as biotechnologies, for the preparation of sterile pharmaceutical products or in hospitals, for operating theatres. Cleanrooms […]