Category Archives: Business Case

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.

Enjoy the Perfect Pasta

casestudy

JOWA AG Pasta has been the largest manufacturer of pasta products in Switzerland since it was founded in 1931. It is important for the company that its production operations run smoothly and meet strict quality standards.

Original Article from www.rotronic.com

Precision temperature and humidity probes from Rotronic are used to measure the climates in the factory’s six production lines, which predominantly manufacture dried pasta for the retailers such as Migros (Switzerland’s largest retailer). As a testament to the quality of Rotronic probes some units are over 15 years old and are still performing as required having only undergone routine calibration and adjustment to ensure that they provide consistently accurate accurate data.

JOWA AG manufactures 18,000 tonnes of pasta per year and is thus the largest pasta producer in Switzerland!

The pasta market is highly competitive and food legislation strict. It is therefore all the more important that the pasta is produced in the finest quality without production stoppages and rejects. The drying process plays a key role in the production of dried pasta and is therefore accorded top priority at JOWA. In order to control the climates optimally, temperature and humidity probes from Rotronic are used in the production lines. To preserve the food for a long shelf life and prevent mould and negative microbiological processes, the pasta is dried to a very specific level. Over drying wastes time, energy and produces a poorer quality product, under drying reduces shelf life and risks spoilage. Humidity and temperatures therefore need to be monitored closely during production. Legislation in Switzerland states that pasta products may not contain more than 13 percent water.

High Demands on Probe Accuracy

JOWA has been manufacturing pasta at its site in Buchs AG since 1963. The requirements of food standards, law and customers are rising continuously.

pasta
Spaghetti Production!

Oliver Höfler, head of the JOWA AG sites Pasta Buchs & Mühle Wildegg, comments:

Every single production step needs to be traceable in ever more detail, down to each single packet of spaghetti. The temperature and humidity of each production step must be recorded exactly.”

 

If unwanted temperature and humidity variations were to occur in the pasta, this could lead to quality defects such as crumbling. The pasta would then dry irregularly and break during cooking. For this reason a sample is taken of every product from the first three and last three pallets for quality assessment. The heads of the different departments evaluate the products daily according to various specified properties such as taste and appearance.

Oliver Höfler explains: “If we have to recall products from various stores, this means an enormous financial loss of several ten thousand francs and also a severe blow to the image of our products. A dissatisfied customer – that is something we cannot afford. For this reason it is essential that we are able to rely on the measuring accuracy of the Rotronic probes to 100 percent.”

In addition to this, samples need to be taken for analysis from ongoing production every four hours. “ We greatly appreciated the open and transparent collaboration with Rotronic.” Oliver Höfler, JOWA AG, Switzerland Migros dried pasta perfectly monitored. Rotronic I200 sensor, providing reliable service for more than 15 years.

Project Workflow: Good and Long-Term Planning

Planning calibration time is the key to success with humidity instruments. JOWA AG in Buchs stops production twice a year, two weeks in winter and two weeks in summer, in order to check all equipment and machinery and so maintain the high quality standards. Andreas Zülle, head of production, ensured that the 50 probes (both the I200 transmitters dating back to at least the year 2000 and the newer HygroFlex5 generation) were disconnected right at the start of the last inspection so that Marko Schulze, Rotronic’s qualification technician on site, could begin calibrating the measuring devices. All probes were also catalogued. Marko Schulze: “JOWA’s planning was ideal, I was able to check all probes and either get them back into shape or replace them, and then we still had enough time to test the newly adjusted probes.”

Product Focus – Rotronic HygroFlex5

hf_stahl_wand_front67_1

The HygroFlex5 series of transmitters connect to our entire range of HygroClip probes and offers analogue and digital outputs for any application.

HC2-S probe provides superb precision and state-of-the-art functionality, taking humidity and temperature measurement to a whole new level of accuracy < 0.8 %rh and < 0.1 K at 23 °C.

Also available with ATEX / Intrinsically safe certification.

 

Smooth implementation of the inspection and calibration procedure was important to Andreas Zülle: “After the calibration, our process specialists were able to start up the production lines again without problem.” Oliver Höfler adds: “We greatly appreciated the open and transparent collaboration with Rotronic, found Marko Schulze to be an extremely competent partner and are sure we will be able to carry out calibration of our instruments even more efficiently next time. They have now been catalogued in detail. On top of that, we can also check the probes during operation with the Hygropalm from Rotronic.” Both sides benefit from good planning and a good working relationship.

Some Interesting Facts about Jowa

  • JOWA Pasta has been producing dried pasta for more than 50 years
  • The durum wheat semolina needed for production comes from a mill in Wildegg that also belongs to JOWA.
  • A team of 46, working three shifts a day, ensure daily that high-quality raw materials are transformed into products at an optimum price-performance ratio .JOWA.jpg
  • JOWA employs a workforce of around 3,200 people and, with more than 140 apprentices and trainees, is the biggest training company in the Swiss bakery industry.
  • JOWA AG is the leading Swiss bakery and supplies its customers from the retail trade, convenience stores and food service sector daily with a wide range of products and individual service concepts.
  • Jowa produce buns, cream slices to pasta, ham croissants and braided bread, some even gluten-free – the bakery assortment goes far beyond the classical bakery range.
  • The service concepts are tailored specifically to the requirements of customers and extend from logistics and marketing to in-store production.
  • The tasty JOWA breads and pastries are very popular.
  • JOWA breads are served fresh on the table daily in every third Swiss household.

 

BETTER AIR MEANS BETTER PERFORMANCE – Customer Application Case Study. Belimo

casestudy

We all know the situation; a meeting where your performance drops sharply. In most cases, this is a direct result of the poor quality of the air in the room.

Original Article from www.rotronic.com

Uncomfortable situations like this need not arise. CO2 displays by Rotronic make it easy to measure air quality, and the results can be used to initiate the appropriate measures. In an enclosed room, some 25 to 35 cubic metres of fresh air per person per hour are needed, given normal activities. This ensures that the carbon dioxide (CO2 ) content remains below 1,000ppm (ppm = parts per million [value of the proportion of carbon dioxide in the air]), and that the volatile substances exuded by humans are extracted to a sufficient degree. By comparison, the CO2 concentration in outdoor air is around 400ppm. The CO2 concentration is a good indication of the quality of the air in a room. The consumption of air rises particularly quickly in meetings, with many people in small rooms. By the time we notice this productivity has already declined. A CO2 sensor is the answer here. Alfred Freitag, Sales Manager for Switzerland at Belimo Automation AG, points out that a meeting should be interrupted when the CO2 concentration reaches 1,200 ppm and the room should be ventilated. The CO2 content in the air then drops rapidly, and productivity increases again.

The right to good air

Every person has a right to healthy indoor air (WHO). In the case of workplaces, the labour laws require that air quality and room climate must not represent a health hazard for employees. In the private sector, there are no regulations, and the owner is responsible. However, the Swiss Cantonal building regulations require energy-efficient buildings. This requirement can be met only when the buildings are airtight. Consequently, free exchange of air is no longer possible. Martin Bänninger, director of the SVLW (Swiss association for air and water hygiene), has this to say: “Most Cantonal building laws, or municipal building regulations, state the principle that a building must not endanger life or health of the building‘s users.” Furthermore, buildings must be erected according to the rules of the building trade, as laid down in the standards, directives and bulletins (SIA, SWKI).

Careful planning of ventilation systems

Today, however, an adequate supply of fresh air cannot be taken for granted. In densely built-up housing areas, normal ventilation through the windows is of limited value. A good room climate cannot be achieved by regular airing in all buildings – climate-regulating systems are a necessity. Building owners and ventilation planners should therefore conform to the specifications in the SWKI Directives – “Hygiene requirements for room air systems and devices” – starting with the positioning of the air intake, through the controls of the ventilation and heating systems to the instruction of the occupiers. In the case of more complex systems, the responsibilities for surveillance and maintenance must also be clearly defined. “The maintenance of the system should have high priority,” Alfred Freitag emphasises. To keep the ventilation systems functioning reliably, and to keep them hygienic, they must be carefully planned, constructed, regulated and maintained. Rotronic CO2 displays can then be used to monitor these ventilation systems, the data being read out via USB stick when necessary. Asked why Belimo decided in favour of the Rotronic CO2 displays, Alfred Freitag says, “We were very competently advised by Rotronic CEO Michael Taraba. He took care of our needs personally. In addition, the visualisation of the measured data was very important to us. They are simple and clear to read on the Rotronic display. Hitherto, Rotronic has proved a very reliable partner.” In addition, the Rotronic display permits global assessment of the air. It measures CO2 , humidity and temperature. This allows suitable countermeasures to be taken.

Product Snap Shot – CO2 Displayco2-panel_front133

The wall-mounted or bench-top CO2 display is
an inexpensive display unit that simultaneously measures and records CO2 , humidity and temperature. Equipped with the field-tested and proven ROTRONIC HYGROMER® IN-1 humidity sensor, this instrument offers unbeatable value for money. The instrument can be configured directly with buttons, and stored data can be exported to a USB stick for analysis with the free Rotronic software package SW21.

Mapping Services from Rotronic

Ensuring product quality while in transit or storage is an important part of the GxP guidelines. To comply with the legal regulations all storage and transport facilities must be thermally mapped to ensure products are not being affected by extreme temperatures. Rotronic specialises in these services and offers efficient and tailored solutions.

What are the typical temperature mapping Applications?Wherever temperature-sensitive products are produced, stored or transported, mapping is indispensable to show that product quality requirements and standards are being met. mapping-process

What do we offer?
Rotronic will discuss with you the details of your mapping project, including timescales, budgets, regulatory requirements to ensure we deliver the optimal schedule. We offer a transparent service structure ensuring you get only what you need. This segmented service has been very well received by our customers. We can even present and detail all GxP compliant data directly to your auditors taking all the stress out of your audits.

mapping

How will you benefit?
• Modular service structure
– Transport qualifications / validation
– Temperature mapping study
– Stress tests – and findings
– GDP training for dealing with drugs
– Servicing and maintenance of the entire system
• Competent supervision by experienced and qualified engineers
• Best accuracy test equipment and competence as renowned logger manufacturer

What do you get?
• Accurate climate data of measured environments (Warehouses, Room, Lorries, etc …)
• FDA and GxP-compliant mapping reports (Basis for audits)
• Detailed data analysis (Provides information on critical areas)
• Ongoing monitoring and alarming on request

What other GxP-Services does Rotronic offer?
• Validation
• Calibration
• Engineering
• Personnel training

What parameters to be monitored?
• Temperature
• Relative Humidity
• CO2
• Differential pressure and Pressure

mapping-options
Rotronic offers device ranges for all applications

Wish to discuss a mapping project? Please contact us today!
Dr Jeremy Wingate

Pharmacy Business Case – MEDICINES NEED WATCHING – CLOSELY!

Business Case BannerColleagues from our Swiss based HQ just outside Zurich have shared with us a great example of an increasingly important application based around the monitoring of medicines in typical high street pharmacies. Pharmacies may look like they simply store medicines on normal shelves but most drugs require strictly controlled and monitored conditions to ensure they reach us in perfect condition! Read on to discover more…

Medicines are sensitive products. Moisture or excessively high or low storage temperatures, can impair their quality. Incorrectly stored medicines lose their efficacy, leading to significant health risks. Correct storage is therefore vital, offering as it does the guarantee that medicines remain safe and efficacious and retain their high quality right up to their expiry date.

Meeting GDP/GMP requirements in pharmacies

The storage of medicines is legally regulated by GDP (Good Distribution Practice) Standard 9.2 and is inspected by the responsible authorities on site.

Insulins and other liquid antibiotics for instance must be stored in medicine refrigerators at a temperature between 2 °C and 8 °C. A temperature range of 15 °C to 25 °C applies to the vast majority of other medicines.It is compulsory to document the storage conditions of all medicines.

To help fulfil the legal requirements, Rotronic has launched the new HL-1D data logger – a convenient, precise, reliable logger that is virtually tailor-made for a medicinal environment.

Rosengarten Rotpunkt pharmacy

The HL-1D data logger has undergone exhaustive testing
under real-life conditions in the Rotpunkt Rosengarten
pharmacy. With its simple handling and remarkable price-performance ratio, the logger offers great potential for any pharmacy.

The Rosengarten Rotpunkt pharmacy is deeply rooted in the community of Bassersdorf, Switzerland and has been at its present location since 1985.

In 2011, Mr. Ivan Mihajlovic took over the directorship and today runs the pharmacy with a total of 10 employees.

Mr Ivan Mihajlovic
Mr Ivan Mihajlovic

“The quick evaluation of the data and the understandable visualization of the measurement values in a PDF report meet all QMS requirements and document the data long-term.”

HL-1D ideal for Pharmacies

Complete measurement chain

Rotronic offers complete solutions for the entire measurement chain. Even if you are already using other data loggers successfully, we have a range of innovative calibration solutions.

HL-1D for pharmacy

If you require more information or wish to discuss any monitoring, control or calibration applications you may have please do not hesitate to contact us.

Dr. Jeremy Wingate
Rotronic UK