RF Enabled Temperature Monitors (May 2009)

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2 RF Enabled Temperature Monitoring (Transportation Cold Chain Mgt) Transportation & Transfer of Biologics April 28 th, 2009 RFID Live Dave Ulrich QA Director GPO Distribution

3 Agenda Background on RF RF and RF-enabled temperature monitoring devices RF Biologic Study (FDA CPG) Why do the pilot and what were the goals RF hardware and supporting infrastructure Implementation issues and challenges Time Out of Refrigeration (TOR) and Mexico goal details General pilot protocol RF-Pilot Results Conclusion 3

4 Definition of Radio Frequency 4 Radio frequency (RF) is a term that refers to alternating current (AC) having characteristics such that, if the current is input to an antenna, an electromagnetic (EM) field is generated suitable for wireless communications at a frequency of about 3Hz to 300GHz RF Range 4

5 Active-Tag use on Airplanes TempTale RF-enabled (RF) temperature monitoring devices operate within a mesh networking environment and interact only with Sensitech s ColdStream Infrastructure components; RF operates within the 915 or 868 MHz ISM band (Industrial, Scientific and Medical) for optimal transmission in high water-content product situations While RF is a Class 4 Active Tag - it is not a beaconing tag; A RF monitor will never transmit until it has detected that it is within the immediacy of an active ColdStream infrastructure, i.e. an operational RF Gateway and/or Repeater; TempTale RF-enabled temperature monitoring devices are compliant with Federal Aviation Administration (FAA) requirements for electronic devices. Lithium Ion batteries used in these active tags are exempt from FAA regulations limiting their transport 5

6 Is RF Safe vs. a Biologic (proteins, enzymes, hormones, etc) 6 FDA CPG does not support utilizing RF on biologics and proteins So far there has been no specific studies done to assure anyone that the use of RF technologies is safe to use on biologic products Executed a study with a vendor of RF antenna and reader technology RF Bio Study Objective Demonstrate that active bio-pharmaceutical ingredients would not be affected by exposure to energy in the RF (radio frequency) range. Two (2) syringe lots filled with a immunoglobulin were utilized to conduct the test All antibodies are proteins - but not all proteins are antibodies. 6 6

7 Expected Results 7 of 19 Theory is that RF is not ionizing, therefore there should be no effect on the biologic Active Site 1 nm wide Radio frequency wave length for this study was 32.9 cm and the wave length of the monoclonal antibody is 1 nm. The energy for the RF wave length cannot resonate within the active region of the monoclonal antibody. There should be no non-heat effect on the antibody. Antibody Antibody (IgG, IgM, etc) Immunoglobulin 7

8 Definition of Radio Frequency 8 Radio frequency (RF) is a term that refers to alternating current (AC) having characteristics such that, if the current is input to an antenna, an electromagnetic (EM) field is generated suitable for wireless communications at a frequency of about 3Hz to 300GHz RF Range 8

9 Test Materials 9 Divided product into three (3) sets of syringes A) Samples remained at mfg ing site B) Samples sent to RF vendor, but not exposed to RF C) Samples sent to RF vendor, exposed to RF Syringes were sent to RF Vendor via overnight delivery. Total of 18 syringes were delivered, nine (9) for sample group B, nine (9) for group C Each group contained 3 syringes from each of the product lots Packaging ensured maintenance of the required 2 C - 8 C for preservation. The TempTale (temperature monitor data logger) which accompanied the product indicated no out of range alarm condition. Prior to the formal exposure process, product was stored under recommended conditions, off-site to ensure that no extraneous RF exposure occurred. The TempTale accompanied the 18 syringes in both transit and storage. 9 9

10 RF Energy Study Conclusions 10 of 19 Purity & Stability analysis showed no significant affect of RF exposure on the protein (the biologic) There was no "non-heat" effect Purity of the drug product from all 3 conditions were equivalent as assessed by purity assays The only effect observed during the RF dosing and testing was a insignificant heat input to the product This minor temp increase caused no measurable effect as observed during the stability testing RF poses no ionizing radiation effect 10

11 Why do this Shipping Pilot? 1. Elimination of manual manipulation of temp recording devices 2. Minimize human action of data collection 3. Leverage remote capture of temp data/alarms 4. Allow for early intervention based upon timely accurate temps/ alarms 5. Troubleshoot shipping lanes 6. Observe effects of different pack-outs easier 7. Confirm manufacturing TOR is acceptable 11

12 Pilot Goals 1. To automate the manufacturing TOR data collection using a RF enabled temperature monitor device; 2. To assist 1) multiple manufacturing sites and 2) supply chains to collate TOR data, with a focus on Mexico 3. Use this info for commercial supply chain temperature data management (for typical supply chain temperature excursions). Limited to 100 RF TempTales (approximately 20 shipments) Note pilot worked this commercial lane is now RF 12

13 Pilot Set up and Data Review Three Lanes: Mfg ing Process Bulk PFS Europe to US Commercial Product from Europe to Mexico 13

14 RF Features / Typical RF Download RF Features Full TempTale temperature recording and alarming Location tracking 300 feet (line of site) read range Inexpensive reader infrastructure Automatic alarm notification by Network uses data encryption 14

15 Results RF-Pilot Automatic alarm notification by . 15

16 RF Pilot Hardware The following hardware is used for shipments of: 1. Unfinished product from Germany to U.S. 2. Finished product from Germany to Mexico 3. Mfg ing TOR 1 Signpost at Germany TPM (Marks beginning of temp recording between manufacturing and transport to Amsterdam airport) 1 Signpost at Amsterdam airport (Marks beginning of transport leg to U.S. or Mexico) 1 Gateway at Abbott Final Packaging Facility (Marks recording of packaging TOR) 1 Repeater at Abbott bulk receiving area (Marks receiving of unfinished product from Netherlands) 1 Signpost at Abbott Distribution Center (Marks beginning of transport to Mexico) 1 Gateway at Mexico 3PL Distribution Center (Marks receiving of finished product from either Amsterdam or Abbott DC) 1 Signpost at Mexico Airport Customs area (Marks entry into the country) 2 Control PCs connected to Gateways at Mexico DC and Abbott Packaging 16

17 1. Implementation Issues and Challenges Installation at TPM TPM made it challenging to install the RF equipment; A site survey was completed with a spectrum analyzer; ColdStream training was completed in local language; The substitution of TempTale4 for the RFTT posed no issues with packaging and distribution seamless transition. Testing of Read Rates using multiple Packaging Configurations Tested multiple monitor placement protocols on multiple shipments from TPM to Abbott; Three pack outs across three box sizes (small, medium, and large) each with two monitors 100% Read Rate. 17

18 2. Implementation Issues and Challenges (cont.) Affiliate s IT Department Established strict computer requirements hindered installation of Gateway control PC and ColdStream software Regional Operations within Abbott Challenging communication across different groups within Abbott including: Germany, Netherlands, Mexico and US; Third parties involved eg. TPM, warehouses, freight forwarders, customs and airports; 18

19 3. Implementation Issues and Challenges (cont.) Third Party Warehouse Facility Installation of computer went smoothly but computer (laptop) was removed by Third Party representative; Finding right frequency because of location close to airport; At delivery of RFTT-monitors in warehouse all monitors were automatically activated due to system settings; Obtaining RF Downloads To collect reads on inbound receipt to warehouse facility in Mexico needed to allow packages to remain in immediacy of reader infrastructure for a minimum of 15 min assuming 40 or less monitors received simultaneously; 19

20 4. Implementation Issues and Challenges (cont.) Certification of RF equipment by Mexican government already had approval in Europe Charge for provisional certification monitors, gateways, repeaters, signposts; Requirements to install a Signpost in Mexico Customs and Ministry of Health staging areas Restricted or no access to facilities; Not able to install equipment in advance of project start date. 20

21 Focus on Mexico Goal Allow better and quicker visibility to data Supply chain temperature excursions are a reality Few seen in manufacturing shipping and control Many seen in distribution to international facilities Assist with the customs import issues at our affiliate Release Process Product release by MOH can take up to 3 weeks. Without RF there is no access to temp data With RFTT we now have access to the monitor data without opening the containers in order to make timely decisions on temp excursions 21

22 Europe Mexico Shipment Route (Segments Recorded) Amsterdam Schiphol Airport (AMS) Air Shipment Amsterdam, Schiphol Airport Mexico City (Transit 1) Mexican Customs Ground Shipment Customs Abbott Mexico (Transit 2) Abbott Mexico 22

23 Trip Segmentation and Summary Statistics Transit 1: Schiphol Airport Mexico City Transit 2: Customs Abbott Facility Schiphol Airport Customs: Mexico City Abbott Facility: Mexico City 23

24 Internal Shipment Multi Graph 24

25 External Shipment Multi Graph 25

26 Observations With the exception of 2 spikes in the data internal monitors stayed relatively stable within the shipping lane Shipments at Schiphol Airport and in the Facility in Mexico see the largest amount of variability in trip length Mexican Customs has a very consistent time limit with the exception of two spikes 26

27 TPM Abbott Lake County Manufacturing TPM Shipment Route (Segments Recorded) Ground Shipment: TPM Amsterdam, Schiphol Airport (Transit 1) Amsterdam Schiphol Airport (AMS) Air Shipment: Amsterdam, Schiphol Airport Chicago, O Hare Airport (Transit 2) Chicago, O Hare Ground Shipment: Chicago O Hare Manufacturing (Transit 3) Abbott Lake County Manufacturing 27

28 Trip Segmentation and Summary Statistics Transit 1: TPM- Sciphol Airport Transit 2: Sciphol O Hare Transit 3: O Hare Abbott LC Manuf TPM Sciphol Airport O Hare Airport Abbott LC Manuf 28

29 Internal Shipment Multi Graph 29

30 External Shipment Multi Graph 30

31 Observations With the acceptation of Chicago, O Hare, all internal segments experienced temperatures below 2.0 C Transit 3 (O Hare Abbott AP-16) and Abbot AP-16 were the internal segments that experienced a maximum temperature above 8.0 C. Those excursions happened at the beginning and end of the trip. Monitors that were labeled external experienced very stable temperatures throughout the trips 31

32 Conclusion The Pilot was a Success Mexico It worked! - Mexico received 8 shipments with RF monitors first results look good - Mexico wants to proceed with RF monitoring from pilot to routine use - Effective Corrective Action capability now with early availability of temperature monitoring results General - Infrastructures are ready - RF-monitors generated reliable, timely data - Pilot partner, Sensitech, was a team player and provided valuable resources throughout the entire pilot to help ensure its success 32

33 RF Enabled Temperature rfidjournalevents.com/presentations Monitors (May 2009) 33