Regulatory Storage of Medical Drugs

casestudyMedicines are sensitive products. Having them stored at temperatures too low or too high can affect their overall quality, potentially making them less effective and even causing adverse effects during use. This means that correct storage conditions are not only essential to ensure medicine quality, they are also required by law.

Why monitor environmental conditions?

Medicine control and EU GDP Guidelines suggest that suitable equipment and procedures should be in place to monitor the environment where medicinal products are stored. Environmental factors to be considered include temperature, light, humidity, and cleanliness. For example, many medicines should be stored between +15°C and +25°C to ensure their quality is maintained. Other temperature-sensitive drugs, such as insulin or some antibiotic liquids must be kept in refrigerators between +2°C and +8°C. If medicines are not stored at correct temperatures they muse be destroyed, resulting in large, unnecessary, financial losses.

How Rotronic can help?

Rotronic has over 50 years’ experience in environmental monitoring to GxP guidelines. With “RMS” Rotronic can provide a monitoring system that was developed based on GAMP5 recommendations, in collaboration with multiple experienced pharmaceutical users to comply with several industry regulations, including FDA CFR 21 Part 11 and EU Annex 11.

RMS is an advanced, modular monitoring system with all data available securely via any device, anywhere. It can provide users with exactly the data they need, in the format they require, with extensive reporting and configurable alarms.

One of the key features of RMS is that not only can it be used with Rotronic hardware, but it can also be used with existing hardware from other manufacturers, as well as interact with other software / hardware platforms. RMS can be provided as a hosted cloud service or using a traditional license whereby the client installs the system on their own servers (local or cloud).

In summary RMS provides….

  • Live and interactive charts for all monitored parameters
  • Full alarm and alerts, easily configured
  • All data available with automated scheduled report generation
  • Complete event logging and compliance with GxP requirements
  • Email, phone, SMS, relay and custom protocol alarm notifications
  • Automatic data back filling and retrospective alarms (ideal for transportation logging)
  • Interactive, user configurable on-screen layouts

Alarming / Reporting

The alarm function in RMS ensures users are alerted whenever conditions stray outside their set limits. For example, if a refrigerator is broken, causing its internal temperature to rise above limits, an alert is triggered, notifying users, via email, SMS, or phone call, to act before medicines are damaged. The warning function can also be used to warn users whenever environmental conditions get close their critical limits, giving time to react before the critical limit is reached. Depending on individual requirements, a detailed alarm report can be automatically generated and sent to selected users via email.

                                                            Rotronic products
RMS KITAutomated solution

The RMS Starter Kit for monitoring storage of medicines includes three wireless temperature loggers, a gateway (wireless receiver) and the corresponding software license. We have also included a service level agreement to help ensure a quick response to any questions that may arise.

Standalone solution

Data logger TL-1D or HL-1D Collage HL-1D.jpg
For a standalone solution, you can use our TL-1D temperature loggers or HL-1D humidity and temperature logger. These battery powered devices record environmental data which can be accessed by connecting the logger, via its USB port, to a PC running the free HW4-LITE software. These devices are not compatible with the RMS meaning data must be accessed manually. Once data has been downloaded, HW4 can be used to generate a detailed PDF report, which includes a graphical representation of the data, along with various statistics, and details of any period during which conditions where outside their alarm limits.

To find out more about our range of monitoring solutions, please contact us on 01293 571000 email: instruments@rotronic.co.uk or visit http://www.rotronic.com/rms

 

 

Rotronic ISO17025 Calibration

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Introduction

Rotronic instruments have a UKAS / ISO17025
accredited laboratory for the calibration of humidity, temperature and dew point instrumentation. We are proud to advise that we can offer some of the lowest measurement uncertainties of any commercial laboratory in northern Europe.

Why is Calibration important?

Calibration is the only way to prove instrument performance. By comparing an instrument against a known reference at several stable conditions we can asses what error exists. Over time we can assess the instruments drift and repeatability. Once errors are know they can be corrected for or adjusted out. ISO17025 calibration is performed with a laboratory that is regularly audited to ensure compliance to strict standards. All ISO17025 laboratories have defined measurement uncertainties and regularly perform inter-comparisons with other laboratories to ensure performance. Calibration is essential for compliance within many industries (FDA, GAMP, ISO 9001) and should be considered by anyone that wishes to make meaningful measurements. Instruments need not be calibrated over their    entire working range, only the range they are used at. For relative humidity it is best to calibrate at the working temperature or over a temperature range.

Evaluating Uncertainty 

Improving quality is the key to mitigating risks and reducing costs. However, measurement uncertainty is a parameter that is often overlooked. It is an important aspect of measurement that affects quality, costs, decisions and risks. Measurement uncertainty is a calculation that defines the range in which the “true value” is expected to lie. Measurement uncertainty is calculated by tabulating the known sources of error in terms of probability distribution. The final result is typically displayed as a value at 95% confidence. Uncertainly is a far better term to use vs accuracy, uncertainly includes details of the specific instrument and how it is used. The need for increased accuracy is not as important as the need for quality measurements and knowledge of measurement uncertainty

Calibration SerPicture1vices – Our comprehensive range of industry leading calibration services include:

  • Calibration of relative humidity measuring instruments using unsaturated salt solutions at 5,10,11,20,35,50,60,65,75,80 & 95%rh.
  • Calibration of dew point measuring instruments over the range -60°C dewpoint to 95°C dew point.
  • Calibration of relative humidity measuring instruments by comparison with a chilled mirror hygrometer and platinum resistances thermometers in the range 0°C to 95°C; 2%rh to 98%rh.
  • Temperature calibration of probes in air -60°C
    to 150°C
  • Temperature calibration of probes in liquid
    -70°C to 200°C

We meet the needs of our customers who cover a wide range of industries and sectors some which include Agrochemical, HVAC, Food,  Medical, Meteorological, Pharmaceutical.

Calibration Solutions from Rotronic

Rotronic offer the most complete range of humidity calibration equipment available on the market today from cost effective to high end solutions to meet all requirements and applications. Rotronic ISO 17025 Calibration labs are situated in UK, Switzerland, Germany and USA.

For information on any of our products and services please visit our website www.rotronic.co.uk

 

 

Simple connectivity with the Rotronic Monitoring System (RMS)

Introduction:

Reducing costs and improving quality are key drivers for any business. RMS applications typically target these aspects of our customers operations and a recent project with here in the UK was no exception.

Following an initial enquiry it was clear that a custom selection of RMS hardware and setup would be required, however this was no reason not to proceed with a bespoke solution.

Customer Process:

The project was based around a wider roll out of a new technology in the manufacturing process of our customer. The process required the use of special epoxy adhesives that themselves require very strict ambient and surface temperature conditions. Outside these conditions the bonding process would not be adequate. As such monitoring was critical to ensure and prove conditions were being met during production.

Some Chemistry:

Epoxy resins a reactive pre-polymers, they have the potential to react and cross link. It is this cross linking that when triggered turns a stable liquid into a thermo-setting polymer. The set polymer typically has extremely high thermal and chemical resistance. Epoxy resins are commonly used as adhesives and coatings in many industries such as carbon fibre and ship building.

What are the monitoring requirements

Ambient conditions and surface temperatures are critical for the client procedure.  The production area was therefore independently controlled by a specific HVAC system. Previous manual checks lacked quantitative detail and were costly to implement

The Solution – RMS Continuous Monitoring

RMS provided the perfect solution. Using an RMS-LOG-868 high accuracy humidity and temperature loggers combined with an economical RMS-MLOG mini-loggers all measurements could be made in real time. A custom magnetic surface temperature probe was utilised so the customer could accurately measure the surface temperature as per their quality requirements. Live ambient dew point was calculated via RMS and then this value was compared with surface temperature using a simple arithmetic calculation. Thus a live trace of surface temperature vs dew point temperature was provided giving a clear indication whether there would be a risk of surface condensation. Parameters were configured with warning and alarm limits linked to emails, SMS and telephone alerts as well as clear visual displays via tablets and PCs.

As such the customer could be confident that should conditions not be favourable they would know, in addition for QA a full record of all conditions was easily available with automated reporting and full audit trail.

API Example5
Live data direct to your PC, Tablet or Mobile device.

Simplifying Connectivity

Cconnectivity was an issue on such a large site. No network access was available at all. A 4G solution resolved these and provided data direct connectivity at all times through out the site.

Fully mobile kit was created requiring only a mains power supply for operation. Wireless loggers could then be moved and placed as required always in range of the 4G communications kit.

Even if connectivity or power was lost for any reason, all the wireless loggers would continue logging on their 3 year batteries and maintain a 1 month record that automatically synchronised back to the RMS software once 4G connection was restored.

The entire system was setup and configured exactly as required from the Rotronic office, including device pairing and software configuration allowing the client to log on from their offices and make comments and changes. A subsequent visit to site met with no technical issues or surprises. This also kept service costs to a minimum for an initial proof of concept project.

RMS - Info Graphic - 4G

4G connectivity reducing need for on-site infrastructure and IT issues.

This is just one example of an RMS implementation. With a range of cloud and on premises software along with wireless and wired devices if you have a monitoring application we are confident we can find a solution to meet your needs and budget.

To find out more about our range of monitoring solutions and instruments contact us or visit http://www.rotronic.com/rms

 

Dr Jeremy Wingate
Rotronic

 

Real Time Monitoring for the Medical Cannabis Industry

Since being legalised in the UK in 2018, cannabis-derived medicinal products can now be prescribed for a variety of health issues. The term medicinal cannabis refers to the use of the whole, unprocessed cannabis plant or its basic extracts.

How Medical cannabis might be a useful medicine

There are two main parts of the cannabis plant that are of medical interest, they are THC and CBD. THC can increase appetite and reduce nausea, it may also decrease pain, inflammation and swelling; CBD is the oil that may be useful in reducing pain and inflammation and controlling epileptic seizures and possibly some mental illnesses.

How monitoring can help?

Maintaining ideal environmental conditions that support cannabis plant cultivation with good growth and development is not easy to achieve. Glasshouse humidity, temperature, lighting and COlevels are all crucial for the prevention of plant diseases and the promotion of healthy and strong plant growth. Rotronic provide a validated real-time continuous environmental monitoring system that measures all parameters with live alarms using our Rotronic Monitoring system (RMS).

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RMS is an advanced, modular monitoring system with all data available securely via any device, anywhere. RMS provides users with exactly the data they need and in the format they require with extensive reporting and configurable alarms. 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 license whereby the client installs the system on their servers (local or cloud).

In summary RMS provides….

  • Live and interactive charts for all monitored parameters
  • Full alarming and alerts, easily configured
  • All data available with automated scheduled report generation
  • Complete event logging and compliance with GxP requirements
  • Email, phone, SMS, relay and custom protocol alarm notifications
  • Automatic data back filling and retrospective alarms (ideal for transportation logging)
  • Interactive, user configurable on-screen layouts

Rotronic has a micro website for RMS – please visit HERE, a technical brochure is available. Call us to discuss your application on 01293 571000.

Get a Free RMS Demonstration Account HERE

Water Activity

Water activity is the measurement of the available or ‘free’ moisture in a product that can support microbiological growth including yeasts, mildew and bacteria. This affects its stability, quality and shelf life. Most cannabis is dried and cured to a final water activity level of 0.30 – 0.60 Aw. Humidity and water activity influence the quality of the cannabis seeds and dried cannabis products.

The wide range of water activity analysers manufactured and developed by Rotronic are easy to use, convenient and provide fast measurements on-site to confirm product quality.

For full technical information on our Rotronic water activity analysers please click HERE. A comprehensive brochure is available. Call us to discuss your application on 01293 571000.

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Rotronic Precise and Reliable Measurement for Weather Stations

casestudy

LSI-Lasten is an Italian company that develops, manufactures and markets a wide range of advanced environmental monitoring systems.  The company was established in 1972 and then began the production of electric thermometers. Later, other parameter devices were added to the product range including relative humidity and air speed utilising the hot-wire method. LSI-Lasten has relied upon the vast sensor technology knowledge of Rotronic over the years and benefits from the use of the outdoor OEM HC2-CP03 cable mount probe in all its sophisticated weather stations. These comprise many different sensors for various parameters, the signals from which are all integrated using data standardisation software. Rotronic meteorological probes measure temperature and relative humidity precisely and reliably. Rotronic offers a wide variety of tailor-made measurement devices which are developed to meet specific customer requirements, for LSI-Lasten the need was for a specified cable length, power supply and outputs with everything designed to fit in a single housing for the installation.

The highest weather station in the world on Mount Everest

By selecting Rotronic sensors, LSI-Lastem was able to ensure not only precise measurement, but also a high level of performance. Mr. Federico Pasquini, chief operating officer at LSI-Lastem, explains:

“The Rotronic probes have completely fulfilled our expectations, because they overcome certain limitations on the measurement of relative humidity in higher regions, even in difficult situations, and this is hard to achieve with other solutions.”

LSI-Lastem specialises in the development and installation of measurement solutions for extreme environments. The company implemented the highest weather station in the world, located on the southern peak of Mount Everest at the amazing height of 8,000 metres. This station includes three Rotronic sensors, demonstrating how the highly developed, reliable technologies by two partners can fully complement each other.

HC2-CP03 Meteorological probe

HC2_S3C_AgroWeissRotronic developed the OEM temperature and humidity cable mount probe for meteorological and outdoor applications. The probe is fitted with a fast response sensor, advanced filter technology that significantly improves protection of the humidity sensor against the formation of biofilm, and an increased power supply range suitable for battery operated systems.

For information on any of our products please contact us  on 01293 571000 or email instruments@rotronic.co.uk.

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Air Humidity and Temperature Under Control

The Laténium in Neuchâtel is the largest archaeological museum in Switzerland, with more than half a million artefacts. The most common problem for the museum in storing the ancient relics, is the variation in air humidity and temperature. There is no air conditioning system in the building, the museum uses temperature and humidity measurement probes to monitor the environment. The Laténium Museum has two laboratories, one where wooden artefacts are dated and which provides highly specialised services, and a laboratory for conservation and restoration work. Rotronic probes are used due to their high precision and advanced functions, they control the environments in glass display cabinets, exhibition rooms and storage areas. The museum houses 524,450 objects dating from the Neanderthal era through to the renaissance. Around 70 Rotronic temperature and humidity probes are installed.

Preserving the Artefacts

1510316889_keller_rke-RK5_5880Finding an archaeological object is of course of great importance. It is first removed from its surroundings and then kept under suitable conditions. During this time, it is expected that the object will start to destruct, the climate plays a huge part in this.  If artefacts are not stored under the right conditions, their condition can deteriorate very quickly; air relative humidity of about 50 % is ideal.

Continuous monitoring system

Thanks to the Rotronic Monitoring system (RMS) the Laténium Museum has a complete overview of the probe installation locations with optimal environmental control. RMS provides a complete, flexible and yet easy to use continuous environmental monitoring solution instead of multiple fragmented and complex systems working in isolation. The RMS software stores all recorded measurements securely in a system that the user can access at any time, data can be retrieved in any form and integrated into third party systems, automated reports are easily generated and sent autonomously to key personnel. The heart of the system is server-based web software with a secure SQL database. It records all data and events generating a range of alerts or warnings when the museum’s defined criteria are breached. The RMS data loggers transmit the measured values to the software via wireless or LAN communication.

The Benefits of Using Rotronic Precision Temperature and Humidity Probes

Organic materials are sensitive to the climate, they will deteriorate following any variations. Artefacts are stabilised at a relative air humidity of 50 %. As the museum is not air conditioned, the curators decided to install climatic controls in every glass cabinet that housed archaeological objects to ensure they were kept at a constant humidity level. Each cabinet has a cartridge fitted containing buffer material. Using the Rotronic RMS software, the museum can control the cabinets from a computer screen. It can provide detailed charts for a year, a week, a day or an hour to suit the application being monitored. These charts allow the curator to track seasonal or weekly fluctuations in humidity and temperature and will identify any anomalies.

The Laténium Museum opted for the Rotronic system because it can achieve high precision in humidity measurement of ± 0.8 %rh while other manufacturers could only offer ±2 %rh.

Scientific projects at the Laténium

The Laténium Laboratory for Conservation and Restoration is involved in various scientific projects in fundamental research as well as applied research (including the development of marketable products). This work is conducted in partnership with the scientific institutes of various colleges and universities in Switzerland as well as other organisations.

Rotronic Monitoring System integration. Pulling data into your systems

Data Integration is Key

Data integration is one of the primary requirements for many of our customers. I have previously discussed how RMS easily supports the integration of external data, but this posts takes a look at how RMS allows you the export data.

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Of course RMS provides excellent graphing, statics and reporting as part of its core functionality, however here we are discussing the tools that will more likely be used for Machine to Machine (M2M) integration.

m2m

Machine to Machine (M2M) integration is absolutely key as data is increasingly being used for different purposes through businesses. So whilst RMS provides a highly secure and configurable platform for monitoring and alarming there are many weird and wonderful functions that it cannot provide. In this case we need to pull the data out and use it elsewhere.

Getting Data out of RMS

RMS is an SQL based system so we could of course query the SQL directly however there are many limitations with this approach especially security. Also via our RMS cloud platform absolutely no direct SQL access is available to end users.

Instead RMS supports a RESTful API, we’ll use a simple example to go through the basic steps.

RMS GET API

As before I’ll use some Python scripts in this example but if you prefer, POSTMAN is a great tool for testing these types of APIs.

Let’s breakdown the steps.

  1. Request API token using your username and password
  2. Use Token to request specific data
  3. Use data as required

Step 1 – Request a Token.

For security reasons you cannot simply send a request and get whatever data you desire. First you must request a token from RMS. The token is linked to a user account and will only allow the data that is visible by that user to be accessed. When requesting a token you can also specify how long it is valid for. The maximum length is 30 days.

import json
import requests

url = ‘https://rms.rotronic.com/RMS/API/RequestToken.ashx’
headers = {‘Content-Type’ : ‘Application/json’, ‘Expect’ : ‘100-continue’, ‘Connnection’ : ‘Close’, ‘Host’ : ‘rms.rotronic.com’}

UsrID = “1”
User= “Jeremy”
PW = “########”
Exp = “30”

get_payload = {‘UserId’:UsrID,’Username’:User,’Password’:PW,’RequestType’:’ DataHistory’,’ExpirationDays’: Exp}
api_get = requests.post(url, headers=headers, data =json.dumps (get_payload))
token = json.loads(api_get.content)
token = token.get(‘Token’)

The above request with suitable credentials will return something along these lines.

{‘UserId’: 1, ‘RequestType’: ‘DataHistory’, ‘Token’: ‘jUsTaNeXaMpLe_HRwOi8vd3d3LnczLm9yZy8yMDAxLzA0L3htbGRzaWctbW9yZSNobWFjLXNoYTI1NiIsInR5cCI6IkpXVCJ9.eyJVc2VySWQiOjM5MzEsIlJlcXVlc3RUeXBlIjoiRGF0YUhpc3RvcnkiLCJFeHBpcmF0aW9uIjoiMjAxOS0wNC0wM1QxNToyMzoyMC44MTgwODM4WiJ9.rtHHKvrE-7jnMNHUGazso_jUsTaNeXaMpLe’, ‘Status’: ‘OK’}

The API token being the jumble of text above. With the token in hand we can proceed with requesting our data.

Step 2 – Request Data

To request data we need the measuring point ID for the data we need which can be obtained from the RMS interface (every measured parameter has a unique ID within RMS that will not change and cannot be reused). We also define the From and To ranges as well as the number of values we wish to obtain (Count).

import json
import requests

url = ‘https://rms.rotronic.com/RMS/API/DataHistory.ashx’
headers = {‘Content-Type’ : ‘Application/json’, ‘Expect’ : ‘100-continue’, ‘Connnection’ : ‘Close’, ‘Host’ : ‘rms.rotronic.com’}

MPTID = “20”
From = “2019-03-04T08:00:00”
To = “2019-03-04T09:00:00”
Count = “10”
Token = “token from step 1”

post_payload = {‘ID’: MPTID,’From’: From,’To’:To,’Count’:Count,’Order’:’Asc’,’Token’: Token}
api_get = requests.post(url, headers=headers, data =json.dumps (post_payload))
data = json.loads(api_get.content)
print (data)

The above request with suitable details will return something along these lines.

{‘Status’: ‘OK’, ‘ID’: 20, ‘Name’: ‘Humidity-18071604′, ‘Parameter’: ‘Humidity‘, ‘Unit’: ‘%rh‘, ‘Data’: [{‘Time’: ‘2019-03-04T08:00:14+01:00′, ‘Value’: ‘29.45%rh‘}, {‘Time’: ‘2019-03-04T08:05:14+01:00’, ‘Value’: ‘29.80%rh’}, {‘Time’: ‘2019-03-04T08:10:14+01:00’, ‘Value’: ‘29.61%rh’}, {‘Time’: ‘2019-03-04T08:15:14+01:00’, ‘Value’: ‘29.29%rh’}, {‘Time’: ‘2019-03-04T08:20:14+01:00’, ‘Value’: ‘29.80%rh’}]}

Step 3 – Use the data

So we have our data in JSON format from here it’s an easy step to chopping out the specific values and handing them over to some other code, machine or simply displaying them for yourself.

The flexibility of RMS is an important requirement for our customers especially those with existing systems. Using RMS as the central platform ensures precision measurements, secure and reliable data collection and easy access to data. Using our  APIs then allows this data to be utilised in wider business operations.

integration examples

Customer examples using the API include

  • Live temperature data included in packaging labels
  • Automated calibration certificate generation using reference values from RMS
  • Visualisation of RMS data on 3rd party software for building efficiency displays

Conclusion

This article focuses on our RESTful API however we have many other options for integration of data including relay output modules, analogue output modules, direct SQL connection. In addition our RMS-Integrator hardware offers direct communication with devices via MODBUS, SNMP and MySQL.

So the message is simple; if you have requirements RMS can usually deliver what you need. Please contact us and we will be happy to discuss your project be it large or small.

Dr Jeremy Wingate
Rotronic UK