ELPRO Introduces GxP Compliant Self-Service Temperature Mapping Kits
25 Feb 2021
The new temperature mapping kits meet a pressing need of COVID vaccine distribution, as pharma and logistics companies expand vaccine storage which must be qualified by temperature mapping in order to comply with current regulations.
ELPRO, the Swiss-based global leader in the manufacture of innovative environmental monitoring technology has introduced three new GxP-compliant remote temperature mapping kits. The new products provide fast, self-service mapping and assessment reports for global pharmaceutical manufacturers and pharma logistics providers.
ELPRO temperature mapping kits are easily implemented for GxP compliant qualification of rooms and equipment for storing temperature-sensitive products, including COVID-19 vaccines. Each mapping kit includes preconfigured data loggers, labeling, systematic instructions, fully compliant post-mapping analytical reports, and remote documentation from ELPRO GxP specialists.
Unlike conventional methods that require expert mapping teams to visit on-site, ELPRO temperature mapping kit protocols are done remotely, eliminating expensive travel costs. They also ensure that projects can continue in a safe, contactless procedure for employees during COVID-19 international travel restrictions.
The three ELPRO remote temperature mapping kits can be used to map rooms and equipment in the following applications:
- Small standalone equipment ≤2m3 (20ft3); Range: -35 °C to +70 °C
- Large standalone equipment between 2m3 – 20m3 (20ft3 – 700ft3); Range: -35 °C to +70 °C, and Small walk-in rooms 18m x 18m (60ft x 60ft); Range: -35 °C to +70 °C
- Upright four-chamber ultra-low freezers; Range: -95 °C to -35 °C
“Our new temperature mapping kits meet a pressing need of COVID vaccine distribution, as pharma and logistics companies struggle to find new vaccine storage which must be qualified by temperature mapping in order to comply with current regulations. ELPRO remote temperature mapping kits provide the perfect solution,” says ELPRO Product Manager Patrick Herburger-Rauter.
“In addition to large pharma and logistics companies, there is also an urgent need for vaccination centers, hospitals, and pharmacies to qualify and map their equipment and storage rooms,” he noted.
The kits cover a broad range of applications – from standalone equipment such as refrigerators, freezers and ultra-low temperature freezers to small walk-in rooms. No previous knowledge or experience is required – users simply follow the systematic instructions. After mapping is completed, a fully compliant analytical report is provided (via elproVIEWER) by ELPRO GxP specialists who generate the analytical report needed for documentation during audits.
- Preconfigured ELPRO LIBERO data loggers / Eliminates configuration hassle and programming errors by customers.
- Temperature Mapping Documentation/Analytical Assessment (elproVIEWER) / Combined protocol and summary report provides complete guidance to ensure data loggers are placed and labeled correctly for an accurate, compliant summary of the room and/or equipment mapping.
- Production calibration certificates for each mapping LIBERO data logger downloaded at Compliance.ELPRO.com. Certificates are available 24/7/365 and easily downloaded from ELPRO’s secure online database.
- Maximum flexibility with one suitable kit for each room or device.
For more information about ELPRO Remote Temperature Mapping Kits, visit Temperature Mapping & Humidity Mapping - GxP compliant | ELPRO. For application questions or ordering information, email firstname.lastname@example.org.