Tag Archives: medical

News, Process

Controlling Critical Decontamination using Rotronic Probes

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casestudy

The Amira company, located in the Province of Brianza, Italy produces devices and machines for use in various sectors, including pharmaceuticals and research centres. The BioReset line of instruments has been developed, patented, and realised in the course of the last few years, and is marketed worldwide. These instruments are for bio-decontamination using hydrogen peroxide vapour, a technology that allows a wide range of bacteria, viruses, and moulds to be eradicated, even at low temperature, and without negative effects on the treated environment. The reason for this is that the corrosive effect of hydrogen peroxide is minimised in its gaseous state.

To ensure that the vapor does not re-condense, Amira integrate specific sensors in their solutions that allow temperature, humidity, and dew-point inside the treated rooms to be
monitored with extreme precision. These Rotronic sensors are resistant to the corrosive effects of hydrogen peroxide.

Reliability and precision
“We had no doubts whatsoever about the choice of components to be used in these areas,” says Angelo Delmiglio, founder and CEO of Amira, who has known and valued Rotronic solutions for over 25 years. “Rotronic products are renowned for their reliability. Thorough comparisons have shown that these products, even in specific cases, are optimally suited to provide the necessary precision and repeatability of the processes.”

From among the many solutions that Rotronic offers for decontamination with hydrogen peroxide, Amira decided in favor of the HygroClip2 (HC2) probe. Thanks to their housing made from corrosion resistant material (polycarbonate or chrome steel, depending on the model), these probes are especially suitable and, with their extreme precision and short response times, ideal for the pharmaceutical industry. International pharmaceutical companies rely on Amira solutions, and in all applications
of this kind, the Amira devices, thanks to part to the high quality of the components used in them, are 100% capable of meeting the customers’ expectations.

AMIRA s.r.l.


The company is highly regarded for the quality of its products, and is active in the global market, where, in addition to its products, it offers comprehensive after-sales service, including verification, calibration, and operator training. The complete BioReset bio-decontamination product line, developed by Amira, is sold all over the world.

For information on any of our products please visit our website here or contact us on 01293 571000.

 

Business Case, CO2, Humidity, News, Process, Sensors, TechNotes, Temperature, Training

What is the latest monitoring system from Rotronic? A practical answer and a technical answer.

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The Rotronic Monitoring System (RMS) has now been officially launched globally for 12 months and in use at some key clients for over two years.

RMS is a modern continuous monitoring system that embraces open architecture and interoperability as well as providing a compliant system for validated applications.

But how is this achieved and what exactly is RMS. There are two ways I find myself answering this…

  • The technical answer – for IT project managers, system integrators and cyber security managers.
  • The practical answer – for end users, project managers and smaller organisations.

What is RMS – The Practical Answer…

The practical answer is more visible via our online demonstration (request guest access here) and via the details on our RMS satellite website.

In short RMS provides a modern and complete monitoring system with a detailed web interface. The system provides users with ease of access to data, reliable and manageable alarms and extensive reporting. Importantly RMS can support existing hardware and interact with other software/hardware platforms.

RMS can be provided as a hosted cloud service or using a traditional licence whereby the client installs the system on their servers (local or cloud).

In summary RMS provides amongst other things…

  • Live interactive charts
  • Full reporting and automated/scheduled report generation
  • Complete event logging in line with GxP requirements
  • Full alarming with logic and time schedules
  • Email, phone, sms, relay and custom protocol alarm outputs
  • Auto back fill and retrospective alarms (ideal for transport logging)
  • Interactive layouts
  • Complete user rights management
  • Compliant to GxP designed around ease of validation

This slideshow requires JavaScript.

Core RMS hardware includes Ethernet, WiFi, industrial wireless and RS485 devices as well as full support for existing Rotronic devices, 3rd party analogue devices and 3rd party digital devices using any of the above interfaces. The below graphic outlines the wide range of options available.

06 RMS Graphic

Contact us for further information or visit our website

What is RMS – The Technical Answer…

Let’s now go a bit deeper. For many organisations once end-users approve of a system the challenge is getting the system approved and installed in line with wider corporate policies and security. So far we have found that in discussions with IT project managers and cyber security managers, RMS has met their requirements – usually much to the surprise of the end users who perhaps initially expect a protracted battle! Typically for larger more secure organisations software is required to be installed within their network rather than using the Rotronic Cloud service. Below we discuss the main elements of this type of RMS installation.

RMS has two core elements.

1. Webservice; This is software aspect of RMS. The webservice provides the interactive webpage to present data for end users and allow system configuration. The webservice also works in the background to interact with hardware and the database. Typically the webpage will be part of the local intranet with an address like rms.yourorganisation.com, optionally the webpage can also be made accessible from the internet outside your organisation (like our cloud service which is available at http://rms.rotronic.com/rms – request guest access to the demo system here). For the clients (end users) no special software or plugins are required just a standard web-browser.

More technically the RMS webservice is built around ASP.Net framework and runs under Windows IIS (internet information services). The webservice therefore requires a Windows Server (2008, 2012 or 2016). The RMS software can be run on a standard PC with IIS enabled but this is not usually advised except for specific applications.

A note on RMS hardware; All Rotronic hardware initiates communication with the webservice via port 80. For cloud applications this means only port 80 must be opened outbound to allow the devices to initiate outbound communications to the server. All gateways have standard IP configurations (DHCP or fixed).

2. SQL Database; The second part of the RMS is its database. All device, configuration, user and measured data is stored within a standard MS-SQL database. The database is accessed by the webservice to store and read data as required. An existing SQL server can be used if available otherwise SQL-Express is free to install.

More technically the RMS database requires Microsoft-SQL Express or higher, the database can be on the same server as the webservice or a separate machine.

As RMS is built around standard server based systems, there is full support for load balancing and failover, as such should a webserver or sql server fail a redundant/spare can take over. This is standard procedure for larger IT systems.

Some other technical points about RMS.

  • Supports LDAP (so you can use windows login and password)
  • No personal data stored outside SQL database (hardware only stores unique serial code, date, time and measured values – as such no private data passes between hardware and software).
  • Webpage data is binary coded and authentication uses AES128 encryption.
  • Key exchange uses diffie-hellman key alogrithm.
  • 3rd party data / device support is possible via RESTful API or direct interaction with SQL database.

An overview of the RMS communication can be seen here.

08 RMS Communication

For many projects clearly we go much deeper but hopefully this provides an overview. Our experience to date has shown that RMS is closely inline with what our clients expect in terms of operations and security. Further developments are always underway, lead by our customers and their requirements.

Please contact us if you wish to discuss a project or gather further information.

Dr Jeremy Wingate
Rotronic UK

Humidity, News, Water Activity

12 Slides explaining Water Activity; what it is and how to use it!

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Water activity is a useful parameter for many industries. Measuring water activity takes only a few minutes so can provide results quickly, ideal for critical control points.

However water activity is a qualitative measure therefore interpreting results can be complex. The following slides provide an overview to water activity and how to utilise Aw measurements.

For further information please do not hesitate to contact us or visit our webpage to download our latest AW White Paper!

Dr Jeremy Wingate
Rotronic UK

 

 

Humidity, News, Process, Water Activity

Five Applications where Water Activity is critical and why!

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Not clear on what water activity is? Check out our other posts on water activity here!

Water activity affects a wide range of products from pharmaceuticals to foods, here we take a brief look at five typical applications where water activity measurements are used.

Remember water activity affects biological, chemical and physical properties of products.

Application 1 – Food

Water activity is critical in food production, reducing water activity reduces the available moisture for spoilage organisms to utilise as such low Aw can limit or prevent growth and spoilage.

Aw is often used to screen raw ingredients or end products to confirm that they are within tolerance. Aw measurements only take a few minutes and can therefore provide immediate feedback. This can save time, money and prevent health risks or product spoilage.

Aw can be used as an excellent indicator of shelf life. Once a production process has been fine tuned to deliver products with suitable shelf-life, online aw measurements can confirm production consistency.

Classic methods to control Aw in food are listed below.Slide14

Application 2 – Paper

Water activity or %equilibrium relative humidity in paper may not be your first thought, but the impact of poor or changing ERH in paper can be very costly. Changes in ERH can cause paper to curl or lead to increased static both of which can cause paper jams. For an industrial printing company this can lead to costly downtime. ERH also affects the binding of inks, drying times and ultimately spoilage by moulds and fungi.Slide15

 

Application 3 – Pharmaceutical Products

Drug production and storage is one of the most highly regulated manufacturing sectors. All stages of drug production, storage and delivery rely on critical control of many factors including water activity. Most drugs must be stored in stable conditions hence the advanced moisture impermeable packaging used. Aw readings as well as humidity monitoring and control are utilised to ensure free water is maintained within tolerance.

Slide16

 

Application 4 – Seed preservation and storage

Seeds present an interesting challenge, if Aw is too low the seeds quickly become non viable, where as too high and they may germinate or suffer spoilage through mould or fungal growth. One of the most critical seed preservation projects is the Millennium Seed Bank project. More details about how Rotronic AW meters were used is avaialble on the Kew Gardens websiteSlide17

 

Application 5 – Soaps and powders

Finally we come to good old washing powder, even with powders and liquids now packed into clever tablets and pods Aw remains critical. The materials must be stored in a way that ensures safe delivery to the customer but can be released once in contact with water in your washing machine. The science of behind the latest washing powders and liquids relies heavily on the measurement and conrtol of water activity and %ERH!Slide18

 

Hopefully this brief in site into how water activity affects so many day to day products has been useful. For more information visit our website or contact us to discuss!

Dr Jeremy Wingate
Rotronic UK

Business Case, Calibration, Humidity, News, Temperature

At the Forefront of Health Care

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casestudy

Original Article from www.rotronic.com

Rotronic has released launched our next generation server based Environmental Monitoring System (RMS), but here we take a look at our traditional system that is still fully supported and widely used in the pharmaceutical industry and beyond. 

The German pharmaceutical manufacturer Dr. R. Pfleger Hygrolog NTGmbH requires specialist cleanroom environments for many areas of production and development. It is vital for the company to monitor and verify pressure conditions as well as humidity and temperature  data in its cleanrooms. To meet this need,the company uses validated Rotronic data loggers from the Hygrolog HL-NT series.

Together with  the Rotronic validated HW4 monitoring software, these data loggers deliver important information on the environments that have an influence on the production of pharmaceutical products.

The Rotronic monitoring system has stood the test of time in the market over many years and undergone continuous development. The HW4 software forms the heart of the system. It visualises and saves all data, configurations and user events and also triggers alarms. Its audit trail logs all data and activities in compliance with FDA21 CFR Part 11 and GAMP5. Rotronic calibrated, qualified and validated Dr. R. Pfleger GmbH’s monitoring system according to GMP requirements.

Overall control and regulation
The management system forms the basis for operation, monitoring and control of the technical facilities as well as for data and message management. Apart from the technical installations, the validated clean room monitoring system is implemented
directly in FIS (OPC interface).

HygroLog HL-NT data logger – The central acquisition unit is a HygroLog-HL-NT data logger. It provides digital inputs for HygroClip humidity and temperature probes as well as Pt100 and 4…20 mA devices.

Dr Pfleger1The data logger is also equipped with a memory card which not only stores the measurement of data but also all the events in the instrument itself.

HC2-S sensors
The digital HygroClip2 climate probes provide class leading precision and long-term stability. All calibration and adjustment data is stored internally. Their standard accuracy ex works is ±0.8 %rh and ±0.1 K, for more demanding tasks, sensors with an accuracy of ±0.5 %rh can be supplied.

Sophisticated Software  – The HW4 software saves the measurement data, alarms and events in a protected binary format. Any manipulations are detected and the data record is then marked as corrupt. Instruments are organised in groups and shown in the room layout. Colour changes make alarms and disturbances easy to recognise.

Evaluation and archiving
A data file is created for every measuring point. Mean Kinetic Temperature values are calculated from this raw data. The evaluation also contains alarm times and deviations and is presented in the form of a table with statistical values. Thanks to the high level of integration of the hardware in HW4, virtually all Rotronic instruments can be implemented in the existing monitoring system.

Customer benefits
The monitoring system implemented by Rotronic offers a consistent solution, since all main and secondary installations and the monitoring system itself are integrated in the FIS management system, they can be monitored and controlled via a central software platform.

Dr. R. Pfleger GmbH

  •  Medium-sized pharmaceutical company located in the city of Bamberg,
  • The company is entirely owned by the Doktor Robert Pfleger-Foundation
  • The company now markets over 30 medicinal products
  • Primary focus on urological, gynaecological, and dermatological indication

For more information on any of our products please visit the Rotronic website.

Calibration, Humidity, News, Sensors

Importance of Monitoring and Controlling Temperature and Humidity in Hospitals

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Control of Temperature and Humidity in Hospitals

Temperature and relative humidity affects the airborne survival of viruses, bacteria and fungi. Thus environmental control in hospitals  is important because of infectious disease transmission from the aerosol or airborne infection.

Environmental exposure is a common hazard for all such organisms (whether viruses, bacteria or fungi) during this journey between hosts. Factors such as temperature, humidity (both relative and absolute), sunlight (ultraviolet light) exposure and even atmospheric pollutants can all act to inactivate free-floating, airborne infectious organisms.

hosp

Maintaining hospital premises at a certain temperature and a certain relative humidity (%rh), likely to reduce the airborne survival and therefore transmission of influenza virus. Temperature and RH settings in different parts of a hospital differ slightly between summer and winter.  In summer, the recommended room temperatures range from 23°C-27°C in the ER (emergency room), including in-patient and out-patient areas, as well as X-ray and treatment rooms and offices. The corresponding recommended RH is fairly constant throughout the hospital, between 50- 60%rh. In winter, the recommended temperatures are generally slightly lower, ranging from 20°C in some in-patient and out-patient areas, as well as offices, up to 24°C -26°C in in-patient and out-patient areas.

 

The recommendations for the newborn baby and the hydrotherapy treatment rooms are higher at 27°C –28°C. Again, the corresponding recommended range of RH is fairly constant, but slightly lower than for summer, ranging from 40%rh -50%rh, but up to 55%rh–60%rh for more critical areas, such as operating theatres and recovery, the intensive care unit and childbirth/delivery suites.

Temperature is one of the most important factors affecting virus survival, as it can affect the state of viral proteins and the virus genome. Virus survival decreases progressively at 20.5°C –24°C then < 30°C temperatures. This relationship with temperature held throughout humidity range of 23%rh- 81%rh.

Facts & figures:
RH (expressed in percentage) describes the amount of water vapor held in the air at a specific temperature at any time, relative to the maximum amount of water vapor that air at that temperature could possibly hold.

At higher temperatures, air can hold more water vapor, and the relationship is roughly exponential—air at high temperatures can hold much more water vapor than air at lower temperatures.

virus

Why do we need to measure relative humidity?

Virus: The survival of viruses and other infectious agents depends partially on levels of RH. At a temperature of 21°C, influenza survival is lowest at a mid-range 40%rh–60%rh. It is also important to note that temperature and RH will always interact to affect the survival of airborne viruses in aerosols.

At High temperatures < 30°C and at high RH <  50%rh may reduce the survival of airborne influenza virus.

Bacteria : For bacteria, the effect of carbon monoxide (CO), enhanced the death rate at less than 25%rh, but protects the bacteria at higher RH ~ 90%rh.

Temperatures above about 24°C appear to universally decrease airborne bacterial survival.

Fungi: Ventilation systems controlling Temperature and Humidity have a significant effect on indoor levels of airborne fungi, with air-handling units reducing, but natural ventilation and fan-coil units increasing the indoor concentrations of airborne fungi.

Dehumidification as well as HEPA filtration can be used to improve indoor air quality.

Different airborne infectious agents (i.e. viruses, bacteria and fungi) will have differing conditions under which they may be optimally suppressed; it will need to be decided which airborne pathogen poses the most risk to patients and staff alike in hospitals.

Thus, in reducing infectious disease transmission specific environmental control of temperature and humidity is vital for hospitals and healthcare premises.

Rotronic can offering a complete system for hospital measurement applications: a proven system that enables healthcare facilities to control and monitor their conditions and remain in conformance with internal or regulatory guidelines.

With the combination of both analogue outputs, controlling the air-conditioning, and digital outputs, linked up to the Rotronic HW4 monitoring software, end users have a clear overview of conditions.

Dr. Jeremy Wingate
Rotronic UK