For perishable products / goods such as finished products, ingredients, medical supplies and pharmaceuticals, it is essential that the temperature and relative humidity of warehouses in which they are stored are attentively controlled. USP Good Storage and Shipping Practices, among other regulatory requirements, such as GMP and FDA, offer guidelines for the safe storage of such materials. Variations in humidity and temperature may have disastrous consequences if they cause things such as medicines to become ineffective or alter the quality of sensitive products.
Weil Group offers effective evaluation and validation of a warehouse's HVAC system to determine the design's suitability for the storage of materials with these requirements. The results are evaluated for approval of the space's intended use, and are also analyzed to document the warm and cold locations of each area for the effective placement of monitoring sensors to ensure continued compliance.
Storage Warehouse Mapping Process
- Up to 300 NIST traceable Wireless Data Loggers available for high resolution Temperature and Humidity Monitoring throughout a Warehouse's HVAC system
- Loggers have a real time display with Temperature and Humidity Readings
- Loggers can also be locally monitored using a smart device with a Bluetooth connection
- Larger Warehouses can be mapped in zones to maintain desired logger density per aisle
- Warehouses as large as 5 acres can be accommodated
Weil Group is offering full service and SELF-SERVICE temperature mapping options to meet your project's cost and delivery requirements.
The full-service option is our standard service delivery, where Weil Group prepares the documents and equipment, and performs onsite execution of the warehouse mapping.
The self-service option offers cost savings by the client supplying the personnel to place preconfigured data loggers at the start of the study, and then read, take down, and return the loggers to Weil Group after the mapping study. Weil Group will supply the instructions, and additional support as necessary to read the loggers after the study concludes. Weil Group provides analysis of the raw data and supplies digital copies of the graphs, summary, and raw data for the study. The client is responsible for documenting logger placement and data results in the protocol.
Warm and Cold Storage Temperature Mapping Validation Services
At Weil Group, we know accurate and consistent autoclave and cold storage temperature performance is critical to meeting regulatory standards and internal goals for excellence. Even the smallest deviation in temperature consistency can have a significant impact on your end results. That's why our highly qualified validation technicians come fully prepared with the latest tools and temperature mapping calibration capabilities to perform temperature mapping validations with industry-leading expertise. Establishing a regular maintenance and calibration schedule with Weil Group for all of your temperature-dependent equipment ensures that you're getting the best return on your investment and that your equipment is performing to the manufacturer’s specifications.
Temperature Mapping Services for Industrial Regulatory Compliance
Weil Group delivers optimized validation by custom designing a protocol for each client to ensure the organization complies with the necessary FDA, EMA, ICH, GMP, ASTM, GLP, or Code of Federal Regulations standards. Each custom protocol is reviewed and approved before our technicians arrive on-site, allowing for an efficient, consistent process that includes:
- 24-hour loaded, empty, or as-is mapping
- Open-door and power-failure recovery studies
- Calibration of pressure gauges and temperature probes
- Conduct loop calibrations with in-line recorders, building monitoring systems, and digital display
- Use NIST traceable wireless or standard data acquisition systems in all our studies
- Biological Indicators to prove biological kill with 106 spore population (Autoclave Validation)