Tag Archives: Pressure

At the Forefront of Health Care

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.

Measuring in clean rooms – Hands on with the Rotronic CRP5

For many years Rotronic products have been widely used in the monitoring and control of clean rooms, however more often than not our products are found out of sight quietly performing their measurement tasks away from areas with strict requirements for cleanliness demanded by modern clean rooms.

In the past few months Rotronic have launched two new clean room panels that are as the name suggests designed specifically for use within clean room environments.

Our flagship product in the field is the CRP5 which we will take a look at first.

crp-5_pfad
CRP5 – Clean room From Rotronic

The CRP5 is a comprehensive clean room panel designed specifically for the requirements of modern clean rooms. Once installed the unit provides virtually no areas for dust to collect and the industrial glass front is extremely resistant to chemicals. With a fully configurable colour screen it is a stylish looking device!

CRP1a
Unpacking the CRP5, the glass front, colour display and stainless steel fittings make the CRP5 elegant, easy to clean and functional

Internally the CRP5 delivers some serious capability, providing potentially a solution for all your clean room measurement and monitoring requirements. Including;

  • Differential Pressure via internal diaphragm sensor (measurement via rear ports and front ports for flexible instalation and calibration).
  • Interchangeable humidity and temperature sensor.
  • Two fully configurable analogue inputs (for particle counters, lux meters etc)
  • Two configurable switch inputs (for pressure or door switches etc)
  • 6 configurable relays (for alarm triggers)
  • Digital connectivity via RS485 and Ethernet (Modbus or direct connection to Rotronic HW4 software)

A unique feature of the CRP5 is the optional flush mount humidity probe. The probe is locked into place through the use of magnets and can easily be removed for cleaning or calibration. An optional rear mount connection is available for Rotronic HC2 humidity and temperature probes should you wish to monitor ducts or spaces remote to the CRP5 itself.

CRP2
The unique removable Humidity and Temperature probe for ease of cleaning and calibration

The configurable colour display shows alarm conditions which can be acknowledged via the front panel. Alarms can be used to trigger relays associated with audible and larger visitual alarms. Interaction with the CRP5 is via four optical buttons –  their use is completely unaffected if operators are wearing protective gloves or not (unlike capacitive interfaces).

CRP3
Optical buttons can be used easily even when wearing gloves!

As an FDA and Gamp5 compliant device the CRP5 is a safe choice for regulated industries. The instrument can be used with 3rd party systems via its analogue outputs or industry standard Modbus TCP / RTU communication. Alternatively the CRP5 can be connected to the Rotronic HW4 software package to provide a one stop solution for monitoring, control and alarming. Pharmaceutical validation services as well as ISO 17025 (UKAS) calibrations are available from Rotronic if required.

To get some more detailed information about our clean room solutions give us a call or visit our website… Rotronic Website and CRP5 Datasheet

Next time we will look at the Rotronic CRP1 a dedicated temperature and humidity clean room panel for  applications with slightly simpler requirements but still demanding a clean installation  and high accuracy measurements!

crp1_side
The CRP1 – Humidity and Temperature measurements in clean rooms.

Dr Jeremy Wingate
Rotronic UK

Monitoring Transportation

Rotronic has recently released a cold chain logger which can be used to ensure items are kept at the correct temperature during transportation.

tl-cc1_0094Rotronic cold chain logger

Transportation in general

One key aspect of today´s wealth in the modern world is specialization. So towns, regions or even whole countries focus on a few things they are really good at. This can be based on various factors; for example resources offered by the land, climatic conditions or specific knowledge that has been developed over a long period and has been passed on from generation to generation. As an example, Cuba provides brilliant conditions for the Corojo and Cirollo plants, better known as tobacco. Although smoking is quite popular among Cubans, their production of tobacco exceeds the local demand by far. On the other hand they lack other resources and goods. At that point trading, and therefore the importance of transportation, comes into play. In the case of the tobacco the transportation is not a simple task, since it requires a constant high humidity level to maintain the high quality expected from a Cuban cigar.

Tobacco-Fields-in-VinalesTobacco plants in Cuba

Like tobacco there are many products where special requirements for shipping have to be put in to consideration, in order to maintain freshness, internal integrity, colour quality or whatever other properties that could be affected by an inappropriate transportation.

Facts & figures:

A major step in the transportation industry was the international standardisation of shipping containers in 1955. This means that one container can be put directly from a vessel to a truck and transported all around the globe.

Today 28´000´000 ISO containers (20 feet) are permanently on the move, transporting goods from point to point keeping our economy running.

Every year 10´000 shipping containers fall over board.

0.16 Euro cents is the cost of transporting a bottle of Chilean whine to Europe.

Why the need to monitor transportation?

Various factors can have a negative impact on a product during transportation. Below are the most common parameters to be monitored to ensure product quality:

Temperature

Controlling temperature is the key in transporting fresh foods, where the rate of decomposition is reduced significantly by maintaining lower temperatures. It is also important as proof of an uninterrupted cool chain for frozen products or to ensure the effectiveness of medication.

truck_insidesthe back of a temperature controlled lorry.

Humidity

Monitoring humidity ensures that the growth of micro organisms in food and medications remains below critical levels. Controlling humidity also helps to maintain structural integrity of paper and cardboard or to avoid corrosion of metals during a long transatlantic journey in a shipping container.

Pressure

Apart of being able to reconstruct when and how long a parcel`s flight was, pressure is also en essential parameter for products that have to be transported in a vacuum or pressured chamber. This method could for example be used when transporting biological samples or hazardous chemicals.

Shock

To guarantee that expensive machinery, glass, works of art and other delicate products weren’t damaged during transportation, monitoring of the G-force in all three axis is the solution.

Rotronic-HygroLog-Log-HC2-P1-Universal-Humidity-and-Temperature-Data-Logger-Humidity-and-Temperature-Measurement---Large-21391770915

 

The Rotronic LOG-HC2 can log light, temperature, humidity, pressure, and shock.

Light

Light is a good parameter to determine if or at what time a container or package was opened. Also to ensure protection of light sensitive products such as vegetable oils, chemical substances or photo paper.

Philip Robinson                                                                                                       Rotronic UK