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.|
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.
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?
• Personnel training
What parameters to be monitored?
• Relative Humidity
• Differential pressure and Pressure
Wish to discuss a mapping project? Please contact us today!
Dr Jeremy Wingate