Category Archives: Business Case

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