Vaisala Webinar GxP Sensor Placement Rules 2016

Modern Rulesfor an Old Practice: Sensor Placement for GxP Temperature Mapping Paul Daniel Senior Regulatory Compliance Expert Practical Webinar Stuff  Challenges with your audio connection?  Try calling toll-free: 866-740-1260  Other technical challenges?  Try logging in to webinar again.  Participate by:  Answering poll questions.  Ask questions using “Chat” function.  You will receive a link to the presentation in email. Page 2 / Sensor Placement for GxP Temperature Mapping – © Vaisala Why are you here?  I need to do a mapping study.  I need to review a mapping study.  Professional Development.  I had an hour to kill… Page 3 / Sensor Placement for GxP Temperature Mapping – © Vaisala POLL 1: What kind of environments are you interested in mapping?  Warehouses  Coldrooms  Refrigerators  Freezers  Incubators  Stability Chambers Page 4 / Sensor Placement for GxP Temperature Mapping – © Vaisala POLL 2: What kind of company do you work for?  Pharmaceuticals  Medical Devices  Biologics  Nutriceuticals  Consulting Firm  Student  Other Page 5 / Sensor Placement for GxP Temperature Mapping – © Vaisala . POLL 3: Is your organization a Vaisala customer?  Yes  No  I’m not sure… Page 6 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Vaisala team Speaker: Paul Daniel Sr. Regulatory Compliance Expert Chat operator: Janice Livingston Marketing Manager Page 7 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Vaisala in Brief  We serve customers in weather and controlled environment markets  80 years of experience in providing a comprehensive range of innovative observation and measurement products and services Page 8 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Life Science Our Offering Provides measurement instrumentation.Vaisala . Our Goal is to help customers • Reduce their risk of lost or adulterated product • Reduce their risk of failing to meet GxP regulations and/or guidelines Page 9 / Sensor Placement for GxP Temperature Mapping – © Vaisala . continuous monitoring systems and validation systems for regulated or highly controlled life science environments. Page 10 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Recent History  Health Canada – GUI-0069 – Guidelines for Temperature Control of Drug Products during Storage and Transportation  ISPE – Good Practice Guide: Cold Chain Management Page 11 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Recent History  PDA – Technical Report 58 – Risk Management for Temperature Controlled Distribution  CDSCO (India) – Guidelines on Good Distribution Practice for Biological Products Page 12 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Recent History  CFDA (China) – Good Supply Practices for Pharmaceutical Products  EMA (Europe) – (2013/C 68/01) Good Distribution Practice of Medicinal Products for Human Use  USP 36 – Chapter <1079> Good Storage and Distribution Practices for Drug Products Page 13 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Page 14 / Sensor Placement for GxP Temperature Mapping – © Vaisala .Recent History  EMA (Europe) – Ref Ares(2014)968163 – 28/03/2014 Good Distribution Practice of Medicinal Products for Human Use – Questions and Answers – Version 1  PIC/S – PIC/S Guide to Good Distribution Practice for Medicinal Products – Note: Nothing new. Identical to EU GDP. Goals  Review Mapping Regulations. Page 15 / Sensor Placement for GxP Temperature Mapping – © Vaisala .  Review Current Guidance on Sensor Placement.  Discuss 5 Rules for Sensor Placement. Regulations and Mapping  The regulations don’t tell us how to map. Ensure that storage spaces are controlled to meet specifications. regulations aren’t very helpful for sensor placement! Page 16 / Sensor Placement for GxP Temperature Mapping – © Vaisala .  Regulatory Summary 1. Determine if environmental parameters affect product quality. 3.  Mapping and monitoring is industry GMP response to #3. 2. or even to map. Do stability testing to determine appropriate storage specifications.  Therefore. Resources for Sensor Placement  Tradition and Precedence  What has been done at your facility before?  Equipment  What equipment do you already have?  Science  What makes sense based on scientific principles?  Guidance Page 17 / Sensor Placement for GxP Temperature Mapping – © Vaisala . For Large Spaces.5 Rules Map the Extremes. Map in 3 Dimensions. Identify and Address Variables. Page 18 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Map Storage Only. its worth monitoring. If it’s worth mapping.  Geometric  Place sensors at each end of the storage area. Page 19 / Sensor Placement for GxP Temperature Mapping – © Vaisala .  Conditions  Apply validation principle of worst cases.Rule 1: Map the Extremes. Parts of a Cube Corner – 3 planes Edge – 2 planes Side – 1 plane Space – 0 planes Page 20 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Parts of a Cube Corner – 3 planes Rule 1: Map the Extremes Space – 0 planes Page 21 / Sensor Placement for GxP Temperature Mapping – © Vaisala . use 9 + 1. TOP SIDE FRONT Page 22 / Sensor Placement for GxP Temperature Mapping – © Vaisala .Corollary 1A: If ≤ 2m3.  Center has most air circulation.  Heat Exchange:  Corners have the most exposure (3 planes)  Center has the least exposure (0 planes) Page 23 / Sensor Placement for GxP Temperature Mapping – © Vaisala .9 spots = worst case?  Air Flow:  Corners have least air circulation. How many? Where? < 20m3 TOP FRONT SIDE Page 24 / Sensor Placement for GxP Temperature Mapping – © Vaisala How many? Where? < 20m3 TOP SIDE FRONT Page 25 / Sensor Placement for GxP Temperature Mapping – © Vaisala How many? Where? < 20m3 TOP SIDE FRONT Page 26 / Sensor Placement for GxP Temperature Mapping – © Vaisala How many? Where? < 20m3 TOP SIDE FRONT Page 27 / Sensor Placement for GxP Temperature Mapping – © Vaisala TOP How many? Where? < 20m3 SIDE FRONT Page 28 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Corollary 1B: If ≤ 20m3. TOP SIDE FRONT Page 29 / Sensor Placement for GxP Temperature Mapping – © Vaisala . use 15 +1. Guidance describes 9 +1 and 15 +1  ISPE Good Practice Guide: Cold Chain Management (2011) Page 30 / Sensor Placement for GxP Temperature Mapping – © Vaisala . 3 planes. Page 31 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Left to right.Rule 2: Map in 3 Dimensions. Rule 2: Map in 3 Dimensions. Top to bottom. Page 32 / Sensor Placement for GxP Temperature Mapping – © Vaisala . 3 planes. 3 planes. Front to back.Rule 2: Map in 3 Dimensions. Page 33 / Sensor Placement for GxP Temperature Mapping – © Vaisala . use Stacks of 3.Corollary 2A: If ≥ 20m3. High Middle Low Page 34 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Stacks of 3. in 3 dimensions. Page 35 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Stacks of 3. Page 36 / Sensor Placement for GxP Temperature Mapping – © Vaisala . in 3 dimensions. in 3 dimensions. Page 37 / Sensor Placement for GxP Temperature Mapping – © Vaisala .Stacks of 3. in 3 dimensions. Page 38 / Sensor Placement for GxP Temperature Mapping – © Vaisala .Stacks of 3. Page 39 / Sensor Placement for GxP Temperature Mapping – © Vaisala . in 3 dimensions.Stacks of 3. Corollary 2A: If ≥ 20m3. High Middle Low Page 40 / Sensor Placement for GxP Temperature Mapping – © Vaisala . use Stacks of 3. it would have 27 sensors.  With “Stacks of 3. in 3-D”. Page 41 / Sensor Placement for GxP Temperature Mapping – © Vaisala .  Remove “extra” sensors.  15 +1 diagram.Corollary 2B: Remove sensors if possible. Stacks of 3. in 3 dimensions. Page 42 / Sensor Placement for GxP Temperature Mapping – © Vaisala . in 3 dimensions.Stacks of 3. Page 43 / Sensor Placement for GxP Temperature Mapping – © Vaisala . “Completing a three-dimensional temperature profile should be achieved by measuring points at not less than three dimensional planes in each direction/axis—top-to-bottom. left-to-right. front-to-back…” USP 36 Chapter <1079> Good Storage and Distribution Practices for Drug Products (2013) Page 44 / Sensor Placement for GxP Temperature Mapping – © Vaisala ...More published support..  Map only the shelves and areas where product is actually stored.  As the space gets larger.  SOPs  Training  Signs Page 45 / Sensor Placement for GxP Temperature Mapping – © Vaisala . map storage only.  Requires controls to prevent storage in wrong areas.Rule 3: If ≥ 20m3. it is not necessary to map hallways and access areas. More published support. left-to-right. “Completing a three-dimensional temperature profile should be achieved by measuring points at not less than three dimensional planes in each direction/axis—top-to-bottom... where product will be present.” USP 36 Chapter <1079> Good Storage and Distribution Practices for Drug Products (2013) Page 46 / Sensor Placement for GxP Temperature Mapping – © Vaisala .. front-to-back. use 9+1. use 15+1 Page 47 / Sensor Placement for GxP Temperature Mapping – © Vaisala .Rule Summary (so far…)  Rule 1 – Map the Extremes  Corollary 1A – If ≤ 2m3.  Corollary 1B – If ≤ 20m3. Rule Summary (so far…)  Rule 1 – Map the Extremes  Corollary 1A – If ≤ 2m3.Map in 3 Dimensions  Corollary 2A – If ≤ 20m3. use 15+1  Rule 2 . use Stacks of 3  Corollary 2B – Remove Sensors if Possible Page 48 / Sensor Placement for GxP Temperature Mapping – © Vaisala . use 9+1.  Corollary 1B – If ≤ 20m3. use Stacks of 3  Corollary 2B – Remove Sensors if Possible  Rule 3 .Map in 3 Dimensions  Corollary 2A – If ≤ 20m3. use 9+1. use 15+1  Rule 2 .If ≥ 20m3.  Corollary 1B – If ≤ 20m3.Rule Summary (so far…)  Rule 1 – Map the Extremes  Corollary 1A – If ≤ 2m3. Page 49 / Sensor Placement for GxP Temperature Mapping – © Vaisala . map storage only. ” – ISPE Good Practice Guide: Cold Chain Management (2011) Page 50 / Sensor Placement for GxP Temperature Mapping – © Vaisala . shelving (storage locations). It’s a place to start. external temperature sources.It’s just guidance.  “…additional points may be needed depending on airflow sources/characteristics. and previous experience with similar units and their thermal behavior. .More from USP 36 Chapter <1079>.  The following factors should be considered during temperature mapping of storage locations:  Size of the space  HVAC Locations  Sun-facing walls  Low ceilings or roofs  Geography  Airflow Page 51 / Sensor Placement for GxP Temperature Mapping – © Vaisala  Outside temperature variability  Weekly workflow variation  Equipment movement  Storage patterns of product  Equipment capabilities  SOPs... Rule 4: Identify Variables Volume Temperature ∆ Height Exterior Walls Construction Materials Doors and Windows Lighting Gradients Page 52 / Sensor Placement for GxP Temperature Mapping – © Vaisala HVAC Vents and Returns Air Circulation Control Sensors Energy Sources Racks and Shelving Traffic Patterns Human Factors . Volume Page 53 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Temperature ∆ Page 54 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Height Page 55 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Exterior Walls Page 56 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Construction Materials Page 57 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Doors and Windows Page 58 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Lighting Page 59 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Gradients Page 60 / Sensor Placement for GxP Temperature Mapping – © Vaisala . HVAC Vents and Returns Page 61 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Air Circulation Page 62 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Control Sensors Page 63 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Energy Sources Page 64 / Sensor Placement for GxP Temperature Mapping – © Vaisala . and Product Page 65 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Shelves.Racks. Traffic Patterns Page 66 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Human Factors Page 67 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Page 68 / Sensor Placement for GxP Temperature Mapping – © Vaisala .Rule 4: Identify Variables  Place sensors near representative variables!  Adjust ideal “grid” to intersect variables. SIDE TOP FRONT (South Wall) Page 69 / Sensor Placement for GxP Temperature Mapping – © Vaisala . SIDE TOP FRONT (South Wall) Page 70 / Sensor Placement for GxP Temperature Mapping – © Vaisala . SIDE TOP FRONT (South Wall) Page 71 / Sensor Placement for GxP Temperature Mapping – © Vaisala . SIDE TOP FRONT (South Wall) Page 72 / Sensor Placement for GxP Temperature Mapping – © Vaisala . SIDE TOP FRONT (South Wall) Page 73 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Temperature Distance Between Points Distance (X) Page 74 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Temperature Distance Between Points Distance (X) Page 75 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Temperature Distance Between Points Distance (1/2X) Page 76 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Temperature Distance Between Points Distance (1/2X) Page 77 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Temperature Distance Between Points Distance (1/4X) Page 78 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Temperature Distance Between Points Distance (1/8X) Page 79 / Sensor Placement for GxP Temperature Mapping – © Vaisala . Temperature Distance Between Points Distance (1/16X) Page 80 / Sensor Placement for GxP Temperature Mapping – © Vaisala . SIDE TOP FRONT (North Wall) Page 81 / Sensor Placement for GxP Temperature Mapping – © Vaisala .  Qualify the monitoring system.  Select the right monitoring solution.Rule 5: If it is worth mapping… It is worth monitoring.  Find the hot and cold spots and monitor them. Page 82 / Sensor Placement for GxP Temperature Mapping – © Vaisala . .” PDA Technical Report No.Monitoring. an appropriate temperature monitoring strategy should be selected and qualified... It allows conclusions on whether the product is stored and shipped within the approved temperature range. “Temperature monitoring… documents the temperatures during the qualification and operation. Therefore. 58: Risk Management for Temperature Controlled Distribution (2012) Page 83 / Sensor Placement for GxP Temperature Mapping – © Vaisala .  Rule 4 – Identify Variables  Rule 5 – If it is worth Mapping. use 15+1  Rule 2 . use Stacks of 3  Corollary 2B – Remove Sensors if Possible  Rule 3 . it is worth Monitoring Page 84 / Sensor Placement for GxP Temperature Mapping – © Vaisala .Map in 3 Dimensions  Corollary 2A – If ≤ 20m3. map storage only.Rule Summary  Rule 1 – Map the Extremes  Corollary 1A – If ≤ 2m3.If ≥ 20m3.  Corollary 1B – If ≤ 20m3. use 9+1. ” -ISPE Good Practice Guide: Cold Chain Management (2011) Page 85 / Sensor Placement for GxP Temperature Mapping – © Vaisala .  Worst case scenario provides best challenge.What about product temperature?  Its always best to measure air temperature. “It is normal practice to use air temperature as the reference source for the stored [product]…” and is ‘the worst case representation of the stored product temperatures. “Where relative humidity is a critical factor.What about mapping humidity?  The same concepts apply.  Use the same number of sensors unless you have an expert who understands humidity theory.” -ISPE Good Practice Guide: Cold Chain Management (2011) Page 86 / Sensor Placement for GxP Temperature Mapping – © Vaisala . but concerned with sources of moisture. then humidity sensors could be located in the same locations – or fewer locations used with the impact of the temperature considered for other locations – as absolute humidity will be very similar throughout the space. I’m interested in… Mapping Services  Yes. I’m interested in… Handheld devices  Yes. Page 87 / Sensor Placement for GxP Temperature Mapping – © Vaisala . I’m interested in… Process Instrumentation  Yes. I’m interested in… Other  No. I’m interested in… Loggers  Yes. I’m interested in… Validation Mapping Kit  Yes.POLL 4: Do you want Vaisala to contact you?  Yes. I’m interested in… Continuous Monitoring System  Yes. thanks.  Explored 5 Rules for Sensor Placement for Mapping Storage Areas. Page 88 / Sensor Placement for GxP Temperature Mapping – © Vaisala .Summary  Reviewed Mapping Regulations.  Reviewed Mapping Guidance. com Page 89 / Sensor Placement for GxP Temperature Mapping – © Vaisala .daniel@vaisala. Email: paul. Inc.Thanks for Attending! Paul Daniel Senior Regulatory Compliance Expert Vaisala.