Temperature Mapping Helps You Maintain a Consistent & Safe Environment.
Temperature control in your facility is key to maintaining the integrity and safety of your pharmaceutical products. At Amicus, we perform a temperature mapping (also known as thermal mapping) study to identify temperature-related problems in your storage and production areas and develop protocols to meet FDA standards. We don’t just find problems; we provide and execute solutions so your facility is always inspection-ready.
Our team of experts works with you to develop protocols that fit your facility's specific needs. We assess and validate all temperature-controlled equipment, warehouses, product storage, incubators, sterilization processes, and more to meet all regulatory requirements. Partner with Amicus to meet FDA compliance and protect the quality of your products.
Providing Accurate Temperature Monitoring Systems & Services
Amicus offers services to find and fix temperature control problems in your facility. We develop and execute custom protocols for FDA compliance, with summary reports, temperature mapping services, and validation services for the following areas:
Warehouse & Product Storage
Incubators
Steam/Sterilize in Place (SIP)
Cycles
Autoclaves
Dry Heat Sterilization & Depyrogenation
Our temperature mapping services and systems are designed to help you comply with FDA standards and maintain the safety and integrity of your products in your facilities.
Custom Temperature Mapping Protocols We never use boilerplate templates for your operational needs. Instead, we perform various tests and assessments to develop custom protocols for your facilities and operations.
Calibrated Data Loggers & Data Collection Systems We utilize calibrated data loggers and data collection systems to map and validate any temperature-controlled units to record accurate temperature data. Slow response times can artificially buffer fluctuating data, which is why we take care to use high-quality and accurate equipment.
Thermal Mapping Validation Services Using precisely placed data loggers, we record the temperature range and humidity levels in your facility to verify that your storage facilities are holding the correct temperature to maintain the integrity of your sensitive products.
Environmental Monitoring Systems These systems allow you to track continuous temperature conditions, allowing you to receive data on early risks and environmental fluctuations.
The Temperature Validation Process
Initial Assessment
Protocol Development
Data Collection
Data Analysis
Reporting
Execution and Support
Frequently Asked Questions
Pharmaceutical products need to be stored at appropriate temperatures to maintain their quality and safety. FDA regulations require this to guarantee the integrity of the products throughout their lifecycle.
Temperature mapping is necessary for warehouses, product storage areas, incubators, stability chambers, refrigeration units, and any other environment where temperature control is critical.
The frequency will depend on your specific operations and regulatory compliance requirements. Generally, it should be done during different seasonal conditions and operational changes to maintain consistent compliance.
Yes, Amicus provides continuous support through the development and execution of protocols.
You will receive detailed summary reports that document the thermal mapping process, findings, and validation results. These reports are important for demonstrating compliance with regulatory authorities.
Achieve FDA Compliance with Confidence
Contact Amicus today to schedule a consultation, and we'll help you with temperature validation for your facility. We are here to help you meet compliance requirements and protect the integrity of your products.
