Environmental Monitoring System
PORPHYRA Provides mapping service, measurement instrumentations (Loggers), continuous monitoring and validation systems complying with 21CFR Part11 or HACCP or MHRA and logger’s calibration for regulated or highly controlled life environments.
Mapping is the process of determining the temperature and humidity gradients within a controlled space. It is a critical process when the product is regulated by government agencies such as the US Food & Drug Administration (FDA) or the European Medicines Agency (EMA) or when the product is under generic good practice (GXP) regulations.
A mapping exercise involves a four-stage process, as follows:
- Prepare a mapping protocol.
- Carry out the mapping exercise.
- Prepare a mapping report.
- Implement the recommendations by carrying out the remedial and other actions identified in the mapping report. A follow-up mapping exercise may then be needed to verify the effectiveness of the remedial actions.
We make mapping based on the 4 fundamental Rules:
- Map the Extremes.
- Map in 3 Dimensions.
- For Large Spaces, Map Storage Only. (It is not necessary to map hallways and access areas).
- Identify and Address Variables.(Volume, Temperature ,Height, Exterior Walls, Construction ,materials, Doors and Windows, Lighting, Gradients, HVAC Vents and Returns, Air Circulation, Control Sensors, Energy Sources, Racks and Shelving, Traffic Patterns, Human Factors
Regulated drugs must meet strict storage conditions including environmental conditions such as humidity and temperature levels. Mapping serves as a baseline for proving compliance within the warehouse storage space and fewer failed audits later.
In addition to regulatory compliance, mapping serves to help ensure products do not spoil or otherwise degrade during storage.
Warehouses are notorious for having warm or cold spots that are outside of the regular control specification. A proper mapping study serves to locate these spots and either modify or avoid the problem area.
It is important for regulators or approvers to understand the philosophy employed for the mapping. A documented strategy will decrease questions from any regulators reviewing your mapping study. The strategy document also helps them understand the data that is produced by the mapping process.
Cold room & Walk-in Freezer
The cold rooms for storage of medicines are normally between 2°C and 8°C. This is a very critical range for most of the medicines. Few hours above 2°C or few hours below 8°C will damage the stored medicines. The walk-in freezer for medicines is normally between -18°C and -22°C. However, there are different requirements up to -40°C.
Countries should not accept a cold room or freezer room from an installer until it has been fully mapped as part of the commissioning procedure.
Cold room mapping is also valuable for existing cold rooms after a major repair.
Ensuring that all areas of a cold room are maintaining optimal temperatures for vaccine storage is critical to
prevent exposure of vaccines to temperatures outside the recommended range.
Installation and Implementation
Using Porphyra‘s installation and implementation service is the quickest and most reliable way to get the job done. By following our four-point plan, our experts will get your system up and running, test the devices to ensure they are working as intended, and stick around to answer any questions. Need help implementing? We’ll work with you to determine and configure best practices based on our experience with your industry.
Easy just got easier. Let us give you your time back by installing our HANWELL loggers.
We’ll take the time to connect your devices to the system and manage any alarms that you request.