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Temperature Mapping Equipment, Procedures and Compliance Kevin Loomis Sr Validation Engineer Panasonic Healthcare Corporation of NA

Temperature Mapping 101 Equipment and facilities are temperature mapped to verify that they have the ability to meet specified performance characteristics. Specifications are established using URS, DS, FS, regulatory compliance criteria and established specifications for the products of the application.

Planning Step 1 – Determine Critical Mapping Points Step 2 – Determine Sample Rate Step 3 – Establish Data Logger Criteria Step 4 – Place Loggers at Pre Determined Points Step 5 – Capture, Retrieve and Evaluate Logged Data Step 6 – Document Processes (and Repeat?)

Regulatory References and Guides for Temperature Mapping 21 CFR Part 210 cGMPs for Manufacturing, Processing or Holding of Drugs

ICH Q10 Pharmaceutical Quality System (2009)

USP Chapter 1079 Monitoring Devices – Good Storage and Shipping Practices (under revision 2011)

21 CFR Part 211 cGMPs for Finished Pharmaceuticals

ISPE Good Practice Guide – Cold Chain Management (2011)

PDA Technical Report No. 52 – Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain (2011)

ISPE Controlled Temperature Chamber Mapping (2012) 21 CFR Part 820 cGMPs for Medical Devices 21 CFR Part 820.150 Storage

PIC/S GMP Guide Part I: Basic Requirements for Medicinal Program Sections 3.19 and 4.9

PIC/S GMP Guide Part II: Basic Requirements for Active Pharmaceutical Ingredients Sections 7.42 and 10.1

Many guides tell you why to map, but don’t tell you how to map! Reference ISPE doc above & IEC 60068-3-11 for methodology.

Temperature Mapping - Basic Equipment Sensors & Systems PRTDs, Thermocouples or Thermisters connected to a recording device. (NIST/ISO17025 Calibrated)

Software for Data, Graphs and Analysis (21 CFR Part 11 Compliant)

Differences in Equipment • • • •

Wired and Wireless Loggers and Live Sensors Software

Equipment Advantages and Disadvantages • Wireless “loggers” are easy to set up, but can’t be monitored live. • Wireless “transmitters” can be monitored live, but signal loss is a concern. • Wired systems are robust, but often create gaps in chamber seals. Limited to sensor wire length. • Integrated software may be easy to use, but may not be regulatory compliant.

Sensors Sensor types should be acceptable for the accuracy and range of the device/system being mapped. TC

Standard Range

Standard Tolerance

Application

J

>0 to 750C

2.2C or 0.75%

OK for refrigerators, unacceptable for incubators and not rated for freezers.

K

>0 to 1250C -200 to 0C

2.2C or 0.75% 2.2C or 2.0%

OK for refrigerators and freezers, unacceptable for incubators.

T

>0 to 350C -200 to 0C

1.0C or 0.75% 1.0C or 1.5%

Good for incubators, refrigerators, and freezers.

Note: A calibrated mapping system will have increased accuracy to that of standard.

Sensor Placement Placement should follow risk based approach using design considerations and expected use. Location considerations follow the same methodology regardless of chamber size.

Refrigerators, Freezers and Cold Rooms • Use forced air flow through evaporator and ducting to remove heat. • Proper air flow is essential to uniformity and temperature control.

Cold Wall Units • Remove heat using evaporator coils encased in the chamber walls. • Not subject to air flow issues. • Uniformity determined by efficiency of refrigerant.

Incubators and Ovens • Heating elements, and fans work together to control temperature and achieve uniformity. • Like refrigerators, proper air flow is essential.

Autoclaves • Mapping should capture temperature and pressure. • Software may assist in determining lethality.

Warehouses, Stability and Dry Storage Chambers • Temperature and Humidity data should be captured. • Proper air flow is essential.

Uniformity Testing • Temperature mapping data helps determine areas in the chamber that may not meet specification.

Dynamic Testing • Open Door testing gives chamber characteristics during normal use. • Power Failure testing gives chamber characteristics during failure and recovery conditions.

Loaded versus Empty Chambers • Empty chambers typically give “Worst Case” performance characteristics. • Loaded chambers typically produce better data as the mass aids in buffering temperature fluctuations.