Temperature Mapping Report

Transcription

1 Document Status: Page: 1 of 13 Temperature Mapping Report Company Name & Site Warehouse Start Date: DD Month YYYY End Date: DD Month YYYY

2 Document Status: Page: 2 of 13 Table of Contents 1 Approvals Introduction Temperature Mapping Study Overview Data Logger Specification Temperature Only Data Logger Configuration Temperature Only Data Logger Certification Excursions: Excursions - Warehouse Non-Conformances Recommendations: Regulatory Recommendations MHRA EUROPEAN COMMISSION Attachments... 13

3 Document Status: Page: 3 of 13 1 Approvals Approval Biomap Ltd: Name Title Signature Date Approval (Company Name): Name Title Signature Date

4 Document Status: Page: 4 of 13 2 Introduction This mapping study documents how conditions change in the stated facility and includes analysis of the results. The study determines where hot & cold spots appear and indicates recommendations for continuous monitoring. In regards to the rationale used for the logger placement, there is no set formula for the density and position of the loggers used. Each mapping exercise requires a site survey to document the perceived risk areas and to ensure product storage areas are captured. Each environment is treated as having individual requirements and will vary based upon its configuration and layout so the resulting logger concentration may vary. Detailed floor plans are provided to illustrate how the loggers were placed during the mapping period. The study results are presented as an independent document, designed to support your internal Standard Operating Procedures (SOP s) and overall regulatory requirements. 3 Temperature Mapping Study Overview Project Code Company & Location Facility Type Warehouse Season Load State Data Logger Type Accuracy Approximate stock levels during the mapping term MP-IN-D-8-L ±0.3ºC from -10ºC to +70ºC (MP-IN-D-8-L) Number of Data Loggers Total Data Loggers Used: 76 Warehouse 74 internal, 2 External Logger Position Date Mapping Started Date Mapping Ended The attached floor plan indicates the exact position of each logger DD Month YYYY DD Month YYYY Required Temperature Range Warehouse: +15 C to +25 C

5 Document Status: Page: 5 of 13 Summary & Findings WAREHOUSE 1. Excursions Excursions were recorded in locations??. Further details can be seen in Section 7 Excursions. 2. General information The Warehouse was under normal use during the mapping exercise. The Warehouse was at approximately??% of capacity during the mapping exercise (detail provided by client). Recommendations Full details of the locations that have been recommended for continuous monitoring are included in Section 9 Recommendations and are also illustrated on the floor plans within this report.

6 Document Status: Page: 6 of 13 4 Data Logger Specification 4.1 Temperature Only Data Logger Type Escort iminiplus (MP-IN-D-8-L) Operating Environment -40ºC to +70ºC Sensor Measurement Range -40ºC to +70ºC Resolution 0.1 Calibrated Accuracy ±0.3ºC from -10ºC to +70ºC ±0.5ºC from -40ºC to -10ºC Memory Capacity Maximum 8048 Temperature data points Memory Type EEPROM Non Volatile IP Rating IP65 (With DB cap on) 5 Data Logger Configuration 5.1 Temperature Only Dataloggers were programmed with the following configurations: Location Warehouse Recording Interval 10 minutes Alarm Range +15 C to +25 C Start Up Delay 4 Hours Location External Monitors Recording Interval 10 minutes Alarm Range Disabled Start Up Delay 4 Hours

7 Document Status: Page: 7 of 13 6 Data Logger Certification The following data loggers were used for the mapping project and full calibration certification for each data logger is included within this report: Logger Number Serial Number Calibration Certificate Number Calibration Date Calibration Due Date

8 Document Status: Page: 8 of 13 Logger Number Serial Number Calibration Certificate Number Calibration Date Calibration Due Date

9 Document Status: Page: 9 of 13 7 Excursions: 7.1 Excursions - Warehouse Logger Serial Number Logger Location Type of Excursion Min/Max of Excursion Total time out of Specification 8 Non-Conformances NC No. Description Impact of NC N/A N/A N/A

10 Document Status: Page: 10 of 13 9 Recommendations: The locations for the positions of Continuous Monitoring Probes (CMPs) are based on the findings of this ENTER SEASON mapping. All locations that recorded excursions (Hot or Cold spots) would usually be recommended by default, however in cases with a high number of excursions it may not be feasible to monitor all of these locations. In this case the extremes in each area/zone have been recommended to provide overall coverage and installation of a temperature control system may also need to be considered. In addition, if no excursions have been recorded, the highest and lowest temperatures are also considered in each area/zone. At the time of the mapping, there were an approximate total of?? x CMPs in place. The following locations are recommendations only and aimed at providing consistent coverage of the facility for the purpose of ongoing monitoring. The excursion locations or locations closest to breaching the target range from each season are listed: Facility WAREHOUSE WAREHOUSE WAREHOUSE WAREHOUSE WAREHOUSE Logger Location Logger Number Comment

11 Document Status: Page: 11 of Regulatory Recommendations 10.1 MHRA Temperature Mapping 17. With rare exception, all warehouses and refrigerators should be temperature mapped prior to use to ascertain the temperature distribution within the area used for handling medicines. The mapping exercise should be repeated where conditions significantly vary, such as with seasonal variation, alteration in storage layout and changes in supply of supplemental heating or cooling. Exceptions to the requirement to temperature map include where multiple monitoring devices spread thorough a storage area provide continuous and thorough monitoring. Mapping may also not be required where temperature storage areas are deemed too small to warrant mapping e.g. of a size to store 2 or 3 totes, in which case temperature monitoring without mapping is adequate. 18. A mapping exercise should consist of a description of the mapping method, including equipment used, placement of probes, responsibilities, types of information to be recorded and method and responsibility for analysing the data. The mapping method is commonly presented as a protocol and should be approved before any data is collected. All persons involved in the exercise should have an appropriate level of experience or training. The mapping exercise should represent conditions of normal use, and in addition to normal storage areas temperature measurement points should include high and low locations, storage areas near heat sources such as skylights and near radiators, cold areas such as returned stock areas near loading lobbies, and within enclosed areas such as controlled drug stores and cupboards. 19. Mapping data should be traceable to the individual equipment taking the record and be traceable to temperature recorder calibration status. Interpretation of results should include any deviations from the original method. If the outcome of the mapping exercise is accepted a summary report including any recommendations for action should be approved. Such recommendations may include the most suitable placement of temperature monitoring devices for routine temperature measurement, reassigning an acceptable warehouse temperature range or the identification of hot spots and cold spots not fit for storage. 20. The same principles apply to mapping of refrigerators and cold rooms as for temperate warehouses. Temperature data should be collected from areas likely to present areas of risk of temperature extremes such as near condensers or doors as well as throughout the general storage area in normal use. Where a new piece of equipment is being mapped the conditions should be representative of use, including buffering to mimic stock holding and opening of the door. Where manual defrosting is carried out this should be included in the data collection period. Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Orange Guide) Chapter 9 UK Guidance on Wholesale Distribution Practice Control and Monitoring of Storage and Transportation Temperatures

12 Document Status: Page: 12 of EUROPEAN COMMISSION Temperature and environment control An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions. Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. The mapping exercise should be repeated according to the results of a risk assessment exercise of whenever significant modifications are made to the facility or the temperature controlling equipment. For small premises of a few square meters which are at room temperature, an assessment of potential risks (e.g. heaters) should be conducted and temperature monitors placed accordingly. Official Journal of the European Union Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human Use (2013/C 68/01)

13 Document Status: Page: 13 of Attachments The following documents are attached to this report: Attachments Description 1. Floor Plans/Schematic s Floor plans/schematics of facility or asset mapped showing exact logger locations 2. Data Summary Report A table showing Min, Max, Average, SD & Recorded Range for each location 3. Graphs Graphs showing logger readings for multiple locations 4. Calibration Certificates Full 3pt Calibration Certificates provided for each Data Logger utilised in the study 5. CD Mapping Data A CD containing the mapping data including source logger files and mapping reports