The Rotronic Monitoring System is a modular system of hardware elements and web-based software. It provides maximum flexibility in installation and ensures readily available data. The data loggers record measurements from Rotronic and third-party sensors and transmit them to the secure database. It stores information and makes it available to users, regardless of whether they access the database via a PC, Mac, tablet or smartphone.
Pharmacy laws and control of therapeutic products require controlled storage of medicines. For example, insulin and some antibiotic syrups need to be stored in special refrigerators. For monitoring of such refrigerators, we offer a special RMS Pharmacy Starter Kit.
The development of legionella in drinking water lines can be prevented by avoiding stagnations, a temperature range of 25 °C to 55 °C and biofilms on the insides of the pipes. Advance warning of risks can be obtained by logging temperature and flow velocity at critical points in the distribution system and evaluating the data.
Climate and light are both factors that influence the preservation of museum exhibits and archive material as they cause damage by accelerating chemical and biological degradation processes. The RMS Museum Starter Kit is perfect for central monitoring of critical parameters.
The HCD-S is a completely digital probe designed for the Rotronic Monitoring System RMS. It measures humidity and temperature and calculates the dew/frost point.
The Rotronic CO2 probes are ideal for office rooms and applications where the quality of room air has a big effect. Together with other measurement parameters, these probes can be integrated in RMS perfectly.
The Rotronic differential pressure probes are ideal for clean rooms, operating theaters and applications where even minor differences in pressure can have a big effect. Thanks to our two different measurement methods (thermal mass flow measurement and diaphragm measurement), we offer the perfect solution for every requirement. Together with other measurement parameters, these probes can be integrated in RMS perfectly.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The T30 temperature sensors are resistance thermometers (Pt100 = positive measurement resistance), meaning that the resistance increases with increasing temperature. The sensors are compatible with the RMSLOG- T30-L, RMS-LOG-T30-868 and RMS-LOG-T30-915 data loggers.
The T30 temperature sensors are resistance thermometers (Pt100 = positive measurement resistance), meaning that the resistance increases with increasing temperature. The sensors are compatible with the RMSLOG- T30-L, RMS-LOG-T30-868 and RMS-LOG-T30-915 data loggers.
The T30 temperature sensors are resistance thermometers (Pt100 = positive measurement resistance), meaning that the resistance increases with increasing temperature. The sensors are compatible with the RMSLOG- T30-L, RMS-LOG-T30-868 and RMS-LOG-T30-915 data loggers.
The RMS-HCD-IC digital probe is characterized by its high performance. Very low current consumption, the highest accuracy, and measurement results within 90 ms (electronics) are its outstanding features. This is due to the new AirChip, which together with the new HYGROMER® HT-1 sensor forms a powerful combination.
The CCA-S-20X is an analog probe with NDIR technology for measurement of carbon dioxide (CO2) for incubators. Developed with a pyroelectric infrared detector with dual temperature compensation and an integrated semiconductor temperature sensor to maximize accuracy and minimize drift. The signal is converted to 4...20 mA by the converter with power supply (CCA-S-20X-SET).
Rotronic offer a range of analog probes to measure the following parameters: Carbon monoxide (CO), carbon dioxide (CO2), chlorine (Cl2), ethylene oxide (ETO), hydrogen (H2), hydrogen sulfide (H2S), hydrogen chloride (HCL), hydrogen cyanide (HCN), ammonia (NH3), methane (LEL), combustible gas (LEL), combustible gas cat bead (LEL), nitrogen dioxide (NO2), nitric oxide (N2O), oxygen (O2), sulphur dioxide (SO2) and volatile organic compounds (VOC). Within the sets, the signal from the sensor is converter to 4...20 mA by the converter with power supply.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The T10 temperature sensors are NTC (Negative Temperature Coefficient) thermistors, meaning that the resistance of the NTC decreases with increasing temperature. The T10 temperature sensors are compatible with the RMS-MLOG-T10-868/915 data loggers.
The data logger is the flexible component between the probe and the database in the ROTRONIC Monitoring System. It stores 44,000 pairs of measured values from the exchangeable HygroClip probe, and transmits them to the RMS database via LAN or wireless link. It guarantees absolute data protection, even if power supply and communications should temporarily break down.
The RMS-LOG-T30 is a data logger with two integrated analog-to-digital converters, to which two PT100 sensors can be connected for high-precision temperature measurement. The measuring accuracy of the data logger with PT100 can be improved by a 1- or 2-point adjustment. The data logger stores 44,000 pairs of measured values and sends them to the RMS database via LAN or wireless interface.
The RMS-LOG-T30 is a data logger with two integrated analog-to-digital converters, to which two PT100 sensors can be connected for high-precision temperature measurement. The measuring accuracy of the data logger with PT100 can be improved by a 1- or 2-point adjustment. The data logger stores 44,000 pairs of measured values and sends them to the RMS database via LAN or wireless interface.
The data logger is the flexible component between the probe and the database in the ROTRONIC Monitoring System. It stores 44,000 pairs of measured values from the exchangeable HygroClip probe, and transmits them to the RMS database via LAN or wireless link. It guarantees absolute data protection, even if power supply and communications should temporarily break down.
The wireless mini data logger is the low-cost data logger in the ROTRONIC monitoring system. Its small housing and wireless interface make it a really flexible data logger. The mini logger is available in various sensor variants: temperature sensor (NTC), external temperature sensor (NTC) & light, voltage measurement, current measurement, or digital switch contact. With this versatility, it can monitor refrigerators and incubators, as well as door contacts and OEM analog devices.
The wireless mini data logger is the low-cost data logger in the ROTRONIC monitoring system. Its small housing and wireless interface make it a really flexible data logger. The mini logger is available in various sensor variants: temperature sensor (NTC), external temperature sensor (NTC) & light, voltage measurement, current measurement, or digital switch contact. With this versatility, it can monitor refrigerators and incubators, as well as door contacts and OEM analog devices.
The wireless mini data logger is the low-cost data logger in the ROTRONIC monitoring system. Its small housing and wireless interface make it a really flexible data logger. The mini logger is available in various sensor variants: temperature sensor (NTC), external temperature sensor (NTC) & light, voltage measurement, current measurement, or digital switch contact. With this versatility, it can monitor refrigerators and incubators, as well as door contacts and OEM analog devices.
The wireless mini data logger is the low-cost data logger in the ROTRONIC monitoring system. Its small housing and wireless interface make it a really flexible data logger. The mini logger is available in various sensor variants: temperature sensor (NTC), external temperature sensor (NTC) & light, voltage measurement, current measurement, or digital switch contact. With this versatility, it can monitor refrigerators and incubators, as well as door contacts and OEM analog devices.
The wireless mini data logger is the low-cost data logger in the ROTRONIC monitoring system. Its small housing and wireless interface make it a really flexible data logger. The mini logger is available in various sensor variants: temperature sensor (NTC), external temperature sensor (NTC) & light, voltage measurement, current measurement, or digital switch contact. With this versatility, it can monitor refrigerators and incubators, as well as door contacts and OEM analog devices.
The wireless mini data logger is the low-cost data logger in the ROTRONIC monitoring system. Its small housing and wireless interface make it a really flexible data logger. The mini logger is available in various sensor variants: temperature sensor (NTC), external temperature sensor (NTC) & light, voltage measurement, current measurement, or digital switch contact. With this versatility, it can monitor refrigerators and incubators, as well as door contacts and OEM analog devices.
The wireless mini data logger is the low-cost data logger in the ROTRONIC monitoring system. Its small housing and wireless interface make it a really flexible data logger. The mini logger is available in various sensor variants: temperature sensor (NTC), external temperature sensor (NTC) & light, voltage measurement, current measurement, or digital switch contact. With this versatility, it can monitor refrigerators and incubators, as well as door contacts and OEM analog devices.
Miniature rh and temperature probe with digital or analog outputs. Designed for environmental control applications.
rotronic/humidity PC62 & PC62V – Reliable digital relative humidity and temperature probeHighly accurate measurements in precision manufacturing applications.
rotronic/humidity PC33 & PC52 – Stable measurements with analog outputCost-effective probes designed for HVAC and controlled environment applications.
The Gateway is the interface between the wireless data logger and the server rms. The Gateway can manage up to 60 data loggers simultaneously, collecting all wireless-logger measurement data, and passing them on to the server rms. When several Gateways are used in the same network, they are configured redundantly. If one Gateway should fail, the measurement values are automatically sent to the server rms via another Gateway.
The RMS Converter allows you to integrate existing devices and networks into the RMS. The RMS Converter acts as an interface, gathering the data of the devices and sending them to the RMS server rms. This way, existing ROTRONIC products with a digital interface can be integrated into the world of the RMS in just a few, easy steps. With a USB dongle, the Converter can be enhanced to a gateway, and can connect to data loggers by wireless link. In addition, external digital OEM devices can be integrated, if desired.
The 8 input, analogue to digital converter was designed to implement all analogue outputs into the digital world of RMS. The 8 inputs offer the flexibility of using a current system with one of the newest and most flexible monitoring systems on the market today.
The 8 input, analogue to digital converter was designed to implement all analogue outputs into the digital world of RMS. The 8 inputs offer the flexibility of using a current system with one of the newest and most flexible monitoring systems on the market today.
The 4-input analogue to digital converter was developed to implement all temperature sensors in the digital world of RMS. The 4 inputs offer the flexibility of using a modern system with one of the newest and most flexible monitoring systems on the market today.
The RMS-ADC-L-R is a data logger with two integrated analog-to-digital converters to which two sensors can be connected for high-precision analog measurement. The data logger stores 44,000 pairs of measured values and sends them to the RMS database via LAN.
FDA CFR 21 Part 11: Electroni records: Electronic Signatures
FDA: Food and Drug Administration.
CFR: Code of Federal Regulations.
ERES: Electronic Records and Electronic Signatures.
The title 21 of the Code of Federal Regulations, established by the Food and Drug Administration in 1997 (latest review in April 2018) regulates on electronic records and electronic signatures (ERES). Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records and handwritten signatures.
EU Annex 11: Computerised systems within GMP-regulated activities
EU: European Union
GMP: Good Manufacturing Practice
GLP: Good Laboratory Practice
GCP: Good Clinical Practice
What was to become the Annex 11 was released in 1991 and updated in January 2011. The Annex 11 can be found with the EudraLex (the rules governing Medicinal products in the European Union) volume 4 (good manufacturing practice). The guidelines state that where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process. The Annex 11 is also a requirement for GLP and GCP in Europe, unifying the requirements for the management of electronic records and electronic signatures in regulated companies.
FDA CFR 21 Part 11 & EU Annex 11 Requirements:
Both the FDA CFR 21 Part 11 and the EU Annex 11 share the mutual goal of safe, validated computer systems for drug manufacturing (GMP). Whereas the Part 11 is a regulation, the Annex 11 is only a guideline to comply with GMP principles within the EU. The FDA CFR 21 Part 11 has an international reach whereas the EU Annex 11 is focused on Europe.
Here are some of the industry standards when it comes to complying with the two titles:
Download the RMS-WP-Vxxx-EN to find out how Rotronic comply to the FDA requirements and the EU guidelines. (Gated content)
European Union good distribution practice:
GDP: Good Distribution Practice
The EU GDP are the guidelines on the principles of good distribution practice of active substances for medicinal products for human use.
The Rotronic Monitoring System is a range of hardware devices and a FDA CFR 21 Part 11 and EU Annex 11 compliant software (link to hardware and software) that help end users comply with the above mentioned requirements.
EURopean union good manufacturing practice:
GMP: Good Manufacturing Practice
The EU GMP lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.
The Rotronic Monitoring System is a range of hardware devices and a FDA CFR 21 Part 11 and EU Annex 11 compliant software (link to hardware and software) that help end users comply with the above mentioned requirements.
World health organisation annex 5
WHO: World Health Organisation
The WHO Annex 5 lays down guidelines for the distribution of pharmaceutical products. Depending on the national and regional legislation on pharmaceuticals, the guidelines may apply equally to products for human and for veterinary use.
The Rotronic Monitoring System is a range of hardware devices and a FDA CFR 21 Part 11 and EU Annex 11 compliant software (link to hardware and software) that help end users comply with the above mentioned requirements.
united states pharmacopeia standards
USP: United states Pharmacopeia
The United States Pharmacopeia (USP) establishes written and physical standards for medicines, food ingredients, dietary supplement products and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity as well as strength, quality, purity and consistency.
The Rotronic Monitoring System is a range of hardware devices and a FDA CFR 21 Part 11 and EU Annex 11 compliant software (link to hardware and software) that help end users comply with the above mentioned requirements.
usp797: Pharmaceutical Compounding - Sterile Preparations
USP: United States Pharmacopeia
The USP797 describes the minimum standards to be followed when preparing compounded sterile human and animal drugs based on current scientific information and best practices for sterile compounding. Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging or otherwise altering a drug or bulk drug substance to create a sterile medication.
The Rotronic Monitoring System is a range of hardware devices and a FDA CFR 21 Part 11 and EU Annex 11 compliant software (link to hardware and software) that help end users comply with the above mentioned requirements.
International Organisation for standardization
ISO: International Organisation for Standardization
The ISO is an independent, non-governmental international organisation with a membership of 164 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. International Standards give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade.
ISO14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
ISO: International Organisation for Standardization
ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644‑7. Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes.
The Rotronic Monitoring System is a range of hardware devices and a FDA CFR 21 Part 11 and EU Annex 11 compliant software (link to hardware and software) that help end users comply with the above mentioned requirements.
IATA: International Air Transport Association
TCR: Temperature Control Regulations
WHO: World Health Organisation
CEIV: Center of Excellence for Independent Validators
The International Air Transport Association (IATA) is the trade association for the world’s airlines, representing some 290 airlines or 82% of total air traffic. The Temperature Control Regulations (2016) is a guide targeted at the stakeholders (shipper, freight forwarder, airline…) involved in the transport and handling of pharmaceutical products to safely meet the requirements. The TCR provides the requirements and standards for the transportation and handling of time and temperature sensitive healthcare products, including pharmaceutical product information based upon the WHO guidelines.
Due to the lack of compliance, standardisation, accountability and transparency across the air transport supply chain, the IATA have created a Center of Excellence for Independent Validators (CEIV) in pharmaceutical logistics with the aim of helping the industry to improve the transport and handling of these products to meet the requirements of shippers and manufacturers:
CEIV Pharma ensure that facilities, equipment, operations and staff comply with all applicable standards, regulations and guidelines expected from pharmaceutical manufacturers.
The Rotronic Monitoring System is a range of hardware devices and a FDA CFR 21 Part 11 and EU Annex 11 compliant software (link to hardware and software) that help end users comply with the above mentioned requirements.
HACCP: Hazard Analysis and Critical Control Point
The United States Food and Drug Administration (FDA) states that hazard analysis and critical control points (HACCP) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:
The Rotronic Monitoring System will measure and help monitor all CCPs and the required scientifically based critical limits (temperature, time, relative humidity, water activity...) defined after the hazard analysis. All events are registered within RMS and documents can be stored within the system, based upon the internal systems used, RMS can also offer a solution for Principle 7; Establish record-keeping and documentation procedures.
The Rotronic Monitoring System (RMS) is a GAMP©5 category 4 software combined with category 1 hardware helping users monitor their GxP compliant applications, looking into the critical quality attributes and monitoring critical process parameters, helping focus on patient safety, product quality and data integrity and compliant to EudraLex Annex 11 and FDA 21 CFR Part 11.
The Rotronic Monitoring System is designed for GxP applications and as of such, Rotronic offer the corresponding services:
The Rotronic Monitoring System (RMS) is a hardware and software solution adjustable to your requirements for a continuous monitoring system. The complete system conforms to GAMP5, Rotronic is well aware that our support is crucial to your project, so we offer a complete solution. From the user requirement specifications to the IQ/OP/PQ with our detailed documentation finishing off with tailor made training for your employees.
Furthermore the RMS software is delivered as a GAMP software category 4 system, but based upon your URS can also be upgraded to a category 5 system. For the validation of a category 5 software, more time and effort is required, but Rotronic will guide you along the way. Our main goal is to fully understand your requirements and deliver the best continuous monitoring system for you and your company.