Temperature, Humidity, and Pressure Mapping
Businesses operating within industries that are regulated by the FDA or those that require Installation Qualification Operation Qualification (IQOQ) or Performance Qualification (PQ) must meet the required storage conditions as specified by these regulating bodies.
Therefore, temperature, humidity, and pressure mapping become an essential factor in achieving compliance.
What is Temperature and Humidity Mapping?
Mapping refers to the process of recording the temperature and humidity levels in a 3-dimensional space.
To create the visual plan or map of the enclosure, technicians place multiple temporary recording devices known as dataloggers throughout the area. These dataloggers allow the user to see the temperature and humidity for each chosen location within the room.
We tend to believe that temperatures and humidity levels in autoclaves, controlled environment rooms, freezers, refrigerators, incubators, and environmental chambers are uniform throughout the space. However, temperature, humidity, and pressure readings can vary significantly from one location to another.
Why is Temperature and Humidity Mapping Important?
In recent years the FDA has increased its sanction regulations for companies who cannot provide sufficient proof of their production controls. As a result, the number of 483s and warning letters issued by the FDA is on the rise.
By becoming aware of the regulations and reasoning behind 483 distribution, other manufacturing companies, including those in the pharmaceutical industry, can become better prepared against making the same mistakes.
Temperature mapping is necessary to identify critical environmental aspects such as temperature and humidity to maintain adequate processes during the manufacturing and storing of environmentally sensitive products.
Who Requires Temperature Mapping?
Temperature equilibrium verification is mandatory for all organizations and individuals involved in any aspect of the storage and distribution of all drug products. The check applies to all environmental processes, delivery, and storage equipment.
The list of organizations that must comply with existing storage and distribution practices includes but is not limited to, the following:
- Manufacturers of drug products for human and veterinary use
- Packaging operations by the manufacturer or a designated contractor
- Repackaging operations
- Laboratory operations at the manufacturer’s or the contractor’s site
- Physician and veterinary offices
- Pharmacies including but not limited to retail, compounding, specialty, mail order, hospital, and nursing home pharmacies
- Importers and exporters of Record
- Wholesale distributors; distribution companies involved in automobile, rail, sea, and air services
- Third-party logistics providers, freight forwarders, and consolidators
- Healthcare professional dispensing or administering the drug product to the end-user
- Mail distributors, including the U.S. Postal Service (USPS) and other shipping services, such as expedited shipping services
- Border Customs storage areas
What Needs to Be Mapped?
- Refrigerators / Freezers
- Stability Chambers
- Freeze dryers
- Hot rooms
- Cold rooms
- Delivery vans
- Transport Chambers
It’s important to note that the monitoring devices used to track temperatures need to be part of any calibration and preventive maintenance program to ensure all environmental monitoring devices remain calibrated for their range of operation.
Our Temperature, Humidity, and Pressure Mapping Capabilities
At Allometrics, we pride ourselves on the quality of our work, and our ability to adapt our services to our client’s specific requirements.
Our temperature, humidity, and pressure mapping capabilities are as follows:
Temperature: -80 – 140 C / 0.5 accuracy
Humidity: 0-90% / accuracy 3-5%
Pressure: 0-5bar / .03 bar accuracy
Our data loggers have the capability to log data as often as once every 0.5 sec to once every hour. We have the capability to perform the minimum 24 hour test for chambers and the seven days suggested for rooms and warehouses.
Additional Benefits of Allometrics Temperature and Humidity Mapping
Our mapping services offer many benefits, including:
- Verification of environmental conditions to ensure the stability of the environment and capture any temperature variances
- We can map a variety of enclosures including autoclaves, controlled environment rooms, freezers, refrigerators, incubators, environmental chambers
- Our mapping meets FDA, IQOQ, and or PQ requirements
- Our temperature, humidity, and pressure mapping service is available for multiple industries, including pharmaceutical manufacturers and distributors, laboratories, crime labs, Department of Health and Human Services, and viable sampling plate manufacturers
- Our mapping service is intrinsically safe
- Customized reporting available
Call today us to schedule your temperature, humidity, and pressure mapping.
Allometrics is the top-rated ISO 17025 accredited laboratory
We specialize in repair, calibration, certification & Temperature, Humidity, and Pressure Mapping request your Free Quote today!