Category Archives: News

Steriline depends on the reliability of Rotronic Measurement Devices

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Steriline, a expanding company in Lake Como Italy has been manufacturing automatic equipment for the pharmaceutical sector for more than 25 years.

Steriline products combine simple basic principles including reliability and precision to delivery world class products and services. So it’s no wonder that the company enjoys an excellent reputation with the world’s leading pharmaceutical companies.

Steriline are focused on the development and production of highly technological and distinct solutions – isolators, for example are used for processes such as quality control and sterility testing, and wherever precise monitoring and control of various environmental conditions, including temperature and humidity, are fundamentally important.

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Steriline Products are used for Aseptic Processing

To ensure precision when measuring humidity and temperature in the isolators, Rotronic instruments are used. Steriline work with Rotronic as equally well known Swiss specialists in high-technology measurement solutions that guarantee the highest quality. Steriline ensure all phases of their production, which take place in the company’s own, strictly controlled manufacturing locations, are subject to comprehensive monitoring processes. This is also true during the manufacture Rotronic humidity measurement transducers such as our HygroFlex5, combined with HC2-S probes, that Steriline uses. The HF5 measures relative humidity and temperature and calculates all psychometric parameters required by HVAC, industrial and pharmaceutical applications.

And it’s not only precision that speaks for Rotronic – Steriline staff have praised the Rotronic customer service too, any necessary maintenance work is carried out quickly and with no red tape, ensuring uninterrupted process continuity.

Reliability to the highest level, in both products and services, make Rotronic instruments the ideal components for manufacturers of machinery for the pharmaceutical industry. We aim to ensure complete conformity to the strict quality requirements of this sector. That’s why Steriline and others depend on  Rotronic for measuring instruments and the technological expertise provided.

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HF5 measures relative humidity and temperature and calculates all psychometric parameters in the fields of HVAC, industry and pharmaceuticals.

For information on any of our products please contact us or visit our website www.rotronic.com

Service & Support at Rotronic UK

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At Rotronic we can offer a wide range of humidity and temperature measurement products, and our dedicated staff are on hand to support with any calibration, technical or sales queries, our products are supported by a network of subsidiaries and distributors worldwide.

What we can we offer?

ISO17025

We are recogonised globally for our ISO 17025 calibration lab, calibration is the only way in which you can confirm an instruments performance. Many regulatory bodies now require instruments to be regularly calibrated to specific standards.

Here at Rotronic UK we provide a range of calibration services from our dedicated on site laboratory including UKAS accredited (ISO17025) calibrations and calibrations that are traceable to national standards. We also provide custom factory calibration and testing for OEM devices.

System Validation

Our products and software are designed to meet the requirements of GAMP5 and FDA 21 CFR Part 11. Validation provides clear documented evidence that specific monitoring systems meet these requirements, that are demanded by a growing number regulatory organisations.

What you can expect from our validation service

  • Creation of user requirment specifications (URS)
  • Preparation of validation plan
  • Development of validation risk assessment and SOPs
  • IQ,OQ,PQ testing, documentation and reporting
  • Final validation reports

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Temperature & Humidity mapping 

We can also offer a simple and effective mapping service to meet you needs, with our range of measurement products and calibration services we can effectively match these requirements from precision UKAS accredited calibration chamber mapping to full scale warehouse mapping

For details on any of our services or products we offer contact us at instruments@rotronic.co.uk or call 01293 571000.

Logging Solutions from Rotronic

In this post we take a look at the important questions you should ask when looking for data loggers.

Since our founding over 50 years ago, data logging has always been a key requirement for our customers and as technology and regulations have evolved so have our products and solutions. We now offer a wide range of devices but it can get confusing knowing which approach to take.

Logger Solutions_sm

When choosing a logging solution consider the following areas…

  1. Parameters – What environmental conditions do you need to measure eg Humidity and Temperature
  2. Accuracy/Calibration – How accurate do you need the results and do you require calibration.
  3. Environmental Conditions – Both the logger operating conditions and monitoring conditions.
  4. Access to Data & Reporting – Live data, manual download etc, software and reporting tools
  5. Local Display – Live values, max/min and local alarming
  6. Power Requirements – Mains, battery or PoE (power over ethernet)
  7. Memory – How long can the device log and is data stable if power is lost
  8. Cost – What it often boils down to, but always consider the cost of not changing what you are doing

Lets look in a bit more detail…

Parameters – Fairly self-explanatory but consider things like calculated parameters (dew point) , it might be better to use two separate devices rather than one. Rotronic offer Humidity, Temperature, CO2, Differential Pressure and Barometric pressure probes, but also many of our loggers accept analogue input signals so you can utilise existing or 3rd party instrumentation.

Accuracy & Calibration – Accuracy specifications can be mis-leading, if you care about your measurements we would always advice pre-delivery calibration. Also consider that often bulky loggers can be slower and more costly to calibrate vs devices with external probes. When considering humidity measurements drift is also a key factor.

Environmental Conditions – Consider both those you need to measure and where the logger will be placed. Many loggers have cable probes that can tolerate adverse conditions where the logger itself cannot. Also be wary of battery life, it is typically only stated for use at ambient conditions.

Access to Data / Reporting – Simple loggers typically require manual downloading of data. For large installations or where regular reporting is required this can quickly become a laborious task. Alternatively look for devices with a permanent connection to the monitoring software. Our latest RMS software provides live alarms, automated reports and users can access live data through a simple web browser, often saving time and money in the long run. Simple reporting is also key so that data can securely be shared. In compliant applications you may also require the ability for users to validate report authenticity.

Local Display – Useful for many applications but as data becomes always available can a mobile device act as the display for you data logger. For large spaces consider the ability to build dashboards in your software so that users can see data whilst operating.

Power Requirements – Devices with non user replaceable batteries lead to downtime and additional costs. Where possible mains or PoE connections ensure battery life is not an issue. Our latest wireless devices ensure >3 year battery life even when logging and transmitting data every minute.

Memory – Should be secure in the event of battery or power failure and sufficient to last either between download events or as a back up in case monitoring software / network connections fail.

Cost – Best to be realistic with your budgets, consider the time costs for not acting and down forget on going service costs such as validation and calibration.

As you can see from the simple overview above it is virtually impossible to have one logger for every application. At Rotronic we have a diverse range of solutions and even these do not cover all eventualities.

If you have monitoring requirements please do contact us to discuss further.

Dr Jeremy Wingate
Rotronic UK

Thermal Mapping – A vital process for all critical environments

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Rausch AG in Kreuzlingen, Switzerland, has researched and used herbs and their extracts to manufacture high quality, innovative and near-natural products for hair and body care since 1890. Rausch is planning to install a monitoring system from Rotronic to ensure that raw ingredients and end products are stored correctly under ideal environmental conditions.

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Rausch AG decided to evaluate and replace the instruments for measurement of temperature and air humidity in its high-bay stores and production rooms more than a
year ago. Due to a great concept proposal, they opted for Rotronic for this project.

To improve the quality of data, a real-time online monitoring system on the LAN is to be installed. The system can provides SMS or email  alarms notifications when temperature and/or humidity variations move outside the defined tolerance range. During the evaluation phase Rotronic recommended Thermal Mapping be undertaken to characterise the critical areas before installing loggers.

Thermal mapping involves the collection of environmental data in monitoring areas before a logging project is actually started in order to find out where the loggers should be installed and where the critical points are located.

Essences and products in the right place                rausch-ag-die-heizung-blubbert-und-leise-rieseln-die-schuppen-huflattich-und-weidenrinde-die-sanfte- (2)
There is, however, another benefit to mapping. Dr Philippe Ch. Auderst, Technical Director at Rausch explains that the essences of dry and fresh herbs have always been of the highest quality and that their correct storage is therefore vital. José Trujillo, Head of Quality Management,
adds: “The mapping will also tell us if we store our raw and end products in the right place.” Some essences need to mature in containers for months before they are ready for use in production.

Installation of the new measurement system
In the first phase Rotronic installed data loggers from the HygroLog HL-NT series in the high-bay stores. Optimum storage is a must. Air humidity should range between 40 and 60 percent and temperature from 16 °C to 24 °C. In a further installation phase the satellite site in Bottig-hofen was equipped with new probes and a LAN-based measurement system.

When and how is mapping used?
Mapping is performed when installing complex measurement systems or where law dictates. Mapping is primarily used in the pharmaceutical and food industries and in any premises where correct climate is critical. To obtain accurate measurement data, it is vital to evaluate the premises and position the loggers correctly. Mapping can also be used for existing measurement systems to check that the loggers are always installed at the right measuring points.

Rausch Facts:

RAUSCH guarantees the highest possible percentage of natural raw materials from nature to ensure that you and your hair stay healthy and beautiful. This is what we stand for – Family Baumann, the third generation. RAUSCH_LOGO

  • RAUSCH uses only tensides (surfactants) which are produced using renewable raw materials and which are ideal for cleansing and treating both hair and scalp.
  • Quillaja bark extract (Quillaia saponaria extract) has a high level of saponins, oxalic acid, quillaic acid, bitter substances and starches. A natural washing-active substance obtained using RAUSCH’s own extraction and maceration methods.
  • High quality, mild tenside (Sodium Laureth Sulfate) manufactured on the basis of Mass Balance* palm kernel oil (Elaeis guineensis L.) and coconut oil (Cocos nucifera L.) with a high level of saturated fatty acids such as lauric acid (44%) and myristic acid (17%) and palmitic acid (8%). Gentle, anionic washing-active substance.
  • Coco glucoside (Lauryl Glucoside) manufactured on the basis of corn starch (Zea sativa L.) and coconut oil (Cocos nucifera L.). Mild, non-ionic washing-active substance.

For more information on the HygroLog HL-NT series or for any other product information please contact us or visit our webiste Rotronic.

 

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

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

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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

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

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

 

 

Five Applications where Water Activity is critical and why!

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