The Vaisala continuous monitoring system for warehouses and distribution centers ensures gap-free records for compliance with Good Manufacturing Practice in the United States, Canada, the European Union, Japan, Australia, and China. With increasing globalization of pharmaceuticals and biotechnology, these products now ship to more widely distributed locations than ever before. Parallel to this trend is an increased regulatory focus on storage and distribution for drugs, biologicals and medical devices.
The Vaisala continuous monitoring system reduces the risk of non-compliance with regulatory requirements for monitoring temperature, relative humidity, and other critical parameters in temperature controlled and refrigerated warehouses. The 24/7 alarming reduces the risk of lost product due out-of-tolerance conditions and reporting is designed for compliance with 21 CFR Part 11. The system comprises viewLinc software with Vaisala’s high-accuracy data loggers and sensors. With easy connectivity to your existing network, the monitoring system easily scales up to 1000+ monitored locations.
Vaisala loggers have on-board memory and power, making them immune to power outages and easy to place where electrical outlets are not feasible. For high- traffic warehouse environments and hard-to-reach shelving, we offer a wireless sensor that is easy to place. This also ensures that sensing devices can be placed so that they are not subjected to environmental extremes that might affect their performance (USP 1079).
What our customers say
"For mapping our 350,000 square foot warehouse, the system reduced the set-up time by 80%."
-Stephanie Cowan, Pharmaplan Valicor
Good Storage and Shipping Practices for Warehouses
The USP’s Temperature Monitoring section under “Environmental Management System” dictates that “a suitable number of temperature recording devices should be utilized to record temperatures and to provide temperature area maps. Thereafter, the units should be monitored in one or more locations, as determined by the results of the mapping study.” Temperatures must be tracked and recorded and an alarm system must be in place for storage areas to ensure that any malfunction of the temperature control system does not result in product being affected by out-of-specification conditions. The General Notices also recommend annual validation/mapping of storage areas in order to maintain an accurate profile of conditions.
In parallel to the guidelines in the USP, 21 CFR Part 211, Current Good Manufacturing practice for Finished Pharmaceuticals, Section 211.142 describes written procedures for drug products. Procedures must include:
(b) Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.
In addition, manufacturers and
distributors need to
perform validation/mapping studies of areas used to store and process
warehouse products. Creating an accurate profile of storage conditions
through a consistent validation program will establish that the
environment is safe for the products it will hold and demonstrate
compliance with GxP regulations. A comprehensive environmental
validation program increases confidence product quality and ensures
compliance during inspections. Sensors in Vaisala’s continuous
monitoring system can be combined with Vaisala’s validation software to
perform accurate environmental profiles. Truly wireless loggers, rather
that thermocouple systems traditionally used in mapping applications,
make the process simple and efficient. Study results are generated in
secure, tamper-proof documents that aid in compliance with 21 CFR Part
Temperature & Humidity Monitoring in Storage Environments & Warehouses
The newest version of the system software viewLinc is available in English, German, French, Chinese, Swedish and Japanese and can be used with a wide range of Vaisala sensors. viewLinc integrates easily with your facility’s existing network, eliminating the cost of installing and maintaining a dedicated network for temperature monitoring alone. Sensing devices connect via Ethernet, PoE, WiFi or a combination of all connectivity options.