GxP Temperature Mapping & Humidity Mapping
Let ELPRO's 30+ years of experience support your efficient and compliant pharmaceutical operations.
Let ELPRO's 30+ years of experience support your efficient and compliant pharmaceutical operations.
Let ELPRO's 30+ years of experience support your efficient and compliant pharmaceutical operations.
Temperature mapping and/or humidity mapping your pharmaceutical equipment and facilities are a global regulatory requirement. ELPRO can help you prove they are functioning properly, so you can get on with your daily business. We can help you temperature map and humidity map all your life science environments, with full GxP compliant documentation.
Large pharmaceutical storage and distribution facilities are an animal of their own. Extensive transport box, container, or fleet mappings can mean a lot of effort. ELPRO offers you an all-in-one mapping service or onsite GxP technicians to support you each step of the way. We save you time and effort - also on data loggers and resources.
ELPRO uses an efficient method for remote mapping that does not incur expenses in the form of travel costs. Based on your floor plan, container layout or network plan, we design the mapping layout individually for you and prepare the data loggers. Your own team can then place and start the data loggers on site. At the end, ELPRO prepares the GxP-compliant mapping report for you.
Mapping can be done for temperature and relative humidity and is performed with data loggers that have a production calibration certificate as standard or are calibrated to ISO 17025 if required.
Ideal for small standalone equipment ≤2m3 (70ft3) such as refrigerators, climate cabinets, incubators, etc.
Ideal for large standalone equipment between 2m3 to 20m3 (70ft3 to 700ft3) and small walk in rooms 18m x 18m (60ft x 60ft)
Ideal for upright four chamber ultra-low temperature freezers in GxP storage areas
1. Download Mapping Report Mapping report with step-by-step instructions, download and read the editing instructions
2. Perform Mapping
Start sensors and place in refrigerator, room or ultra-low temperature freezer
3. Request Evaluation
Read out the data loggers, scan the partially completed mapping report and send to GxP ELPRO
4. Finalize Mapping Report
Evaluate the mapping report and finalize the GxP compliant report
Simple Implementation
Order kit, place mapping data loggers
and create the report
Step-by-Step Guide
The report provides valuable information on GxP compliance and guides you through the process
GxP Compliance
Mapping loggers are GAMP 5 validated,
mapping is WHO and ISPE compliant
Evaluation from GxP Specialist
The results of the mappings are evaluated
by GxP specialists
Flexibility
A separate kit for each room / equipment
and temperature range
Peace of Mind
Have a clear conscience
before the next audit
With 30+ years of experience in the highly regulated pharmaceutical industry, our experiences are include complying with regulations in most major country markets. We put some of our best knowledge and examples together for you to get started.
Learn from the extensive examples of mapping different environments. ‘How to’ videos cover many topics including how and when to calibrate temperature sensors, processes for equipment qualification and active/passive container qualification.
ELPRO uses state of the art temperature and humidity data loggers and central databases to support your seasonal temperature mappings and/or humidity mappings, equipment validation, and larger qualification projects.
elproCLOUD is an out-of-the-box, self-service, continuous monitoring solution for your network of equipment or small facilities. It’s the easiest move to get continuous visibility and point-by-point environmental data. Learn more about the wireless sensors and elproCLOUD.
ELPRO’s GxP consulting and teams of validation engineers can advise you the best risk-averse qualification strategy for your storage or in-transit environments. We help you create strategies for network qualification, transport qualification, and/or qualification of your warehouse.
Complete the form below to tell us a little more about upcoming projects, and we’ll have one of our GxP services professionals contact you to set up a project scoping call and gather all the details. We look forward to speaking with you soon.
we prove it.
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