VALIDATION SERVICES

Warehouse Temperature Mapping

Is Your Warehouse To Hot? To Cold? Are you Not Sure?

Purple Diamond can assist with cGMP and Pharmaceutical Requirements. 

Temperature Mapping and Validation for warehouses and storage areas are vital for meeting requirements of USP 1079 and cGMPs standards in pharmaceutical/biotech industries. Assuring that environmentally sensitive items are stored in a properly maintained and consistent temperature is crucial.

Thermal temperature mapping is conducted to verify thermal conditions throughout a storage facility. A wide range of goods; food, beverage, pharmaceutical and more are considered temperature sensitive. According to World Health Organization, Technical Report Series No. 961, 2011, it is a requirement for standard, cold and freezer storage.

Purple Diamond Validation Services can perform custom mapping to fit customer needs. Both the mean kinetic temperature (MKT) along with the statistical calculations will be calculated per each parameter (per assigned protocol). Calculated MKT shows the effects of average temperature variations both high and low on stores products. Also note that single high or low readings will have a larger effect on the MKT than the statistical average.

 

Simplified Validation Plan

1. Select Proper Data Logger

2. Survey Site (Warehouse)

3. Establish Acceptance Criteria

4. Determine Logger Locations

5. Map Site

6. Evaluate Recorded Data

7. Present Findings

Chamber Mapping Qualification

Have you Qualified Your Chambers per 21 CFR part 211?

The Engineers at Purple Diamond perform periodic mapping of your chamber conditions and confirm that they are consistent with Good Chamber Practices (GCP). With the use of data loggers, we monitor the long-term temperature capabilities of your chamber. While the monitoring is similar for that of warehouse mapping, chambers can change their temperature capabilities to match custom needs.

Environmental Stability Chambers will produce a consistent temperature that can be tested with the use of data loggers. Long term monitoring will allow us to see if your chamber temperature and relative humidity remains consistent.

Ramping Chambers, also known as cycling chambers, can move from an extreme cold to an extreme heat throughout the storage process. These chambers are able to ramp through a multitude of temperatures set at a specific predetermined time to stimulate actual situations.

Mapping Services available for temperature, relative humidity (RH), vacuum and pressure compliance.

Cold Chain Validation

Is Your Product Reaching Its Destination Safely and Without Temperature Excursions?

Cold chain validation will ensure that your packaged products’ temperature will maintain its temperature-range for the duration of shipment throughout its supply chain.  Each product is treated uniquely due to its specific temperature needs. The variables of when (season in which its being shipped), where (environmental climate along distribution route), and how it is being shipped (transportation method) are the factors we validate to. At Purple Diamond, our expert Engineers can validate the temperature quality of your products packaging. 

See Full List of Purple Diamond Testing Capabilities 

 

Equipment Validation

Purple Diamond equipment compliance can validate and document the quality of your equipment through independent procedures tailored to you. Validation assures that your equipment is meeting specific requirements of its intents and purposes. Our Engineers qualify equipment based on its reliable performance, operations along with its installation. Typical validations are performed on new or modified equipment to ensure it’s in working correctly before its used.

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