Temperature Mapping in Pharmaceutical.pptx
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This presentation provides a comprehensive overview of Temperature Mapping, an essential process in ensuring compliance with GMP, GDP, and regulatory guidelines for storage and distribution of temperature-sensitive pharmaceutical products. It covers: Importance of temperature mapping in pharmaceutical facilities (e.g., warehouses, cold rooms, freezers, incubators) Guidelines from WHO, FDA, EU GMP, and ICH Sensor placement strategy and duration of study Interpretation of temperature mapping data Common deviations and corrective actions Real-world examples and best practices Relevance in qualification (DQ/IQ/OQ/PQ) and annual revalidation. Whether you're from Quality Assurance (QA), Validation, or Cold Chain Management, this resource offers valuable insights into maintaining the integrity of medicines throughout storage.
Temperature Mapping in Pharmaceutical.pptx
- 1. TEMPERATURE MAPPING Presenter: Manager QA Miss Shehar Bano Magns Pharmaceuticals
- 2. Temperature Mapping Temperature Mapping study is the process to identify the difference or changes in temperature (Where applicable) that occurs within a warehouse/walk in rooms & Chambers due to the influence of the system and/or Equipments and by the outside environment condition. TM identified Temperature distribution within the zone being mapped and it locates hot and cold spots.
- 3. Why we conduct Temperature Mapping Study? • Temperature mapping exercise is required by regulatory bodies for any space allocated for the storage and handling of products with a specified labeled storage temperature. i. Freezer Rooms ii. Cold Rooms iii. Temperature-controlled Storage Areas iv. Quarantine Areas v. Receiving and Loading Bays.
- 4. References WHO PIC/S HEALTH CANADA ISPE FDA TRS No. 961, 2011-Temperature mapping of storage areas PIC/S Guide to Good Distribution Practice for Medicinal Products PE 011- 1, June 2014 Health CanadaGUI-0069- de to Good n Practice mal Products June 2014Guidelines for Temperature Control of Drug Products during Storage and Transportation (2011) ISPE Good Practice Guide - Cold Chain Management (2011) ISPE Controlled Temperature Chamber Mapping (2012) 21 CFR 210 Manufacturing Processing or Holding of Drugs 21 CFR Part 211 CGMP for Finished products
- 5. Pre-Mapping Preparations Identification of area dimensions (L×W×H) HVAC system/Equipments which support the area should be qualified prior to temperature mapping study. Risk assessment (hot/cold spots, door proximity, vents) Preparation of area layout and grid plan Data logger selection and calibration
- 6. Placement of Data Loggers • Grid-based horizontal placement (e.g., every 5–10 meters) • Vertical placement at: • Floor level (~0.3 m from floor) • Mid-height (~2.4 m in a 4.8 m high room) • Top level (~0.3 m below ceiling) • Critical location monitoring: • Near doors/windows • HVAC vents • Center of room • Hard-to-reach areas
- 7. Ceiling Height ≤3.6m Ceiling Height >3.6m Low Floor level Medium 1.2m High 3m Bottom Middle Multiple 0.3m Top Middle Multiple Middle Multiple Ceiling Height 6m 1.8m 3.6m 5.4m
- 8. Stages of Temperature-mapping process : Four Stages • ➤ Prepare a mapping protocol • ➤ Carry out the mapping exercise • ➤ Prepare a mapping report • ➤Implement the recommendations
- 9. Methodology • Step 1- Select Electronic Data Logging monitor : Sufficient memory 3-point calibration completed and Valid (within the current year), and have an error of no more than - 0.5. Valid calibration certificates for each of the data loggers used in the study must be included in the mapping report. Step 2-Designate the mapping team: Identify and list the team members and Record their signatures Ensure that all team members received training needed to perform their assigned tasks.
- 10. • Step 3-survey the site: Conduct a site survey of the area(s) to be mapped. The following information is required for each thermally separate area being mapped: Length, width and height; Drawing of each area, showing elements, such as shelving or pallet racking that may have an effect on the even heating or cooling of the space and which may affect its temperature stability. The shelving or pallet racking will be used to place the EDLMs, so it is important to record these components accurately; The location of heating and cooling components, including air distribution outlets and/or ceiling fans;
- 11. Mapping Study Duration & Scenarios Typically, for warehouses and other ambient storage areas, it should be run for a minimum of seven consecutive days – including five working days and two weekend days. For temperature-controlled equipment which is not critically affected by diurnal or seasonal variations in ambient temperature (e.g. freezer rooms and cold rooms), the mapping study should be run for between 24 and 72 hours, or longer if justified. Special studies: • Power failure simulation • Door opening simulation • For new areas Empty vs. loaded condition mapping
- 12. Data Analysis & Acceptance Criteria • Evaluation of recorded temperature ranges • Compliance with labeled storage condition: • Example: 15–25°C or 2–8°C • Identification of excursions and justification • Graphical data review (heat maps, time graphs)
- 13. • Cold Spot • Lowest temperature(s) recorded in the space over the study period, but these lowest temperature(s) remain within the specified temperature range (e.g. cold spots identified between +15.0 °C and +17.5 °C in a room with a specified temperature range of +15.0 °C to +25.0 °C). • Hot Spot • Highest temperature(s) recorded in the area studied over the study period, but these highest temperature(s) remain within the specified temperature range (e.g. hot spots identified between +23.0 °C and +25.0 °C in a room with a specified temperature range of +15.0 °C to +25.0 °C).
- 14. Periodic requalification? • When there is no change or abrupt behavior Study conducted after every 03 years (20 days Margin) • For periodic Requalification study conducted on real time basis. If storage areas are affected by seasonal temperature variations, at least two temperature-mapping studies may be needed. one during the warmest season and one during the coldest season.Typically, two-season mapping is not necessary for cold rooms and freezer rooms. • When any significant change in system i.e. Performance of System change form its predetermined parameters, Modification in Area, Replacement of HVAC supporting system or Its parts
- 15. Post-Mapping Controls • Routine monitoring system setup (real-time or manual) • Alarm and deviation handling • Requalification frequency (typically every 3 years or on change)