Vaisala Webinar GxP Sensor Placement Rules 2016

8/17/2019 Vaisala Webinar GxP Sensor Placement Rules 2016

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Modern Rulesfor an Old Practice:

Sensor Placement for GxP Temperature Mapping

Paul Daniel

Senior Regulatory Compliance Expert


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Page 2 / Sensor Placement for GxP Temperature Mapping – © Vaisala

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Practical Webinar Stuff


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I need to do a mapping study.

I need to review a mapping study.

Professional Development.

I had an hour to kill…

Why are you here?


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Warehouses

Coldrooms

Refrigerators

Freezers

Incubators

Stability Chambers

POLL 1: What kind of environments areyou interested in mapping?


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Pharmaceuticals

Medical Devices

Biologics

Nutriceuticals

Consulting Firm

Student

Other

POLL 2: What kind of company do youwork for?


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Yes

No

I’m not sure…

POLL 3: Is your organization a Vaisalacustomer?


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Vaisala team

Speaker:

Paul Daniel

Sr. Regulatory Compliance Expert

Chat operator:

Janice Livingston

Marketing Manager


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Vaisala in Brief

We serve customers in weather and controlledenvironment markets

80 years of experience in providing a comprehensiverange of innovative observation and measurement

products and services


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Vaisala - Life Science

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

Our Offering

Provides measurement instrumentation, continuous monitoring systems and

validation systems for regulated or highly controlled life science

environments.


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Health Canada

– GUI-0069 – Guidelines for Temperature Control of

Drug Products during Storage and Transportation

ISPE

–

Good Practice Guide: Cold Chain Management

Recent History


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PDA

– Technical Report 58 – Risk Management for

Temperature Controlled Distribution

CDSCO (India)

–

Guidelines on Good Distribution Practice for BiologicalProducts

Recent History


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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 Good Storage and Distribution

Practices for Drug Products

Recent History


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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.

Recent History


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Review Mapping Regulations.

Discuss 5 Rules for Sensor Placement.

Review Current Guidance on Sensor Placement.

Goals


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The regulations don’t tell us how to map, or even to map.

Regulatory Summary

1. Determine if environmental parameters affect product quality.

2. Do stability testing to determine appropriate storage specifications.3. Ensure that storage spaces are controlled to meet specifications.

Mapping and monitoring is industry GMP response to #3.

Therefore, regulations aren’t very helpful for sensor placement!

Regulations and Mapping


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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

Resources for Sensor Placement


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5 Rules

Map the Extremes.

Map in 3 Dimensions.

For Large Spaces, Map Storage Only.

Identify and Address Variables.

If it’s worth mapping, its worth monitoring.


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Rule 1: Map the Extremes.

Geometric Place sensors at each end of the storage area.

Conditions

Apply validation principle of worst cases.


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Parts of a Cube

Corner – 3 planes

Edge – 2 planes

Side – 1 plane

Space – 0 planes


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Parts of a Cube

Corner – 3 planes

Space – 0 planes

Rule 1: Map the Extremes


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Corollary 1A: If ≤ 2m3, use 9 + 1.

TOP

FRONT

SIDE


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9 spots = worst case?

Air Flow:

Corners have least air circulation.

Center has most air circulation.

Heat Exchange:

Corners have the most exposure (3 planes)

Center has the least exposure (0 planes)


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How many? Where? < 20m3

TOP

FRONT SIDE


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How many? Where? < 20m3TOP

FRONT

SIDE


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FRONT

SIDE


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FRONT

SIDE


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FRONT

SIDE


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Corollary 1B: If ≤ 20m3, use 15 +1.

TOP

FRONT

SIDE


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ISPE Good Practice Guide: Cold Chain Management (2011)

Guidance describes 9 +1 and 15 +1


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Rule 2: Map in 3 Dimensions.

3 planes.

Left to right.


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3 planes.

Top to bottom.


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3 planes.

Front to back.


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Corollary 2A: If ≥ 20m3, use Stacks of 3.

High

Middle

Low


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Stacks of 3, in 3 dimensions.


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Corollary 2A: If ≥ 20m3, use Stacks of 3.

High

Middle

Low


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Corollary 2B: Remove sensors if possible.

Remove “extra” sensors.

15 +1 diagram. With “Stacks of 3, in 3-D”,

it would have 27 sensors.


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“Completing a three-dimensional temperature profile shouldbe 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 Good Storage and Distribution

Practices for Drug Products (2013)

More published support....


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Rule 3: If ≥ 20m3, map storage only.

As the space gets larger, it is not necessary to map hallways

and access areas.

Map only the shelves and areas

where product is actually stored.

Requires controls to prevent

storage in wrong areas.

SOPs

Training

Signs


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“Completing a three-dimensional temperature profile shouldbe achieved by measuring points at not less than three

dimensional planes in each direction/axis—top-to-bottom,

left-to-right, front-to-back, where product will be present.”

USP 36 Chapter Good Storage and Distribution

Practices for Drug Products (2013)

More published support....


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Rule 1 – Map the Extremes Corollary 1A – If ≤ 2m3, use 9+1.

Corollary 1B – If ≤ 20m3, use 15+1

Rule Summary (so far…)


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Rule 1 – Map the Extremes Corollary 1A – If ≤ 2m3, use 9+1.


Rule 2 - Map in 3 Dimensions Corollary 2A – If ≤ 20m3, use Stacks of 3

Corollary 2B – Remove Sensors if Possible

Rule 3 - If ≥ 20m3, map storage only.

Rule Summary (so far…)


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“…additional points may be needed depending on airflow

sources/characteristics, shelving (storage locations), external

temperature sources, and previous experience with similar

units and their thermal behavior.”

– ISPE Good Practice Guide: Cold Chain Management (2011)

It’s just guidance. It’s a place to start.


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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

Outside temperature variability

Weekly workflow variation

Equipment movement Storage patterns of product

Equipment capabilities

SOPs.

More from USP 36 Chapter ...


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Rule 4: Identify Variables

VolumeTemperature ∆

Height

Exterior Walls

Construction Materials

Doors and Windows

Lighting

Gradients

HVAC Vents and Returns Air Circulation

Control Sensors

Energy Sources

Racks and Shelving

Traffic Patterns

Human Factors


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Volume


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Temperature ∆


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Height


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Construction Materials


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Lighting


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Gradients


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HVAC Vents and Returns

C


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Air Circulation

C l S


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Control Sensors

E S


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Energy Sources

R k Sh l d P d t


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Racks, Shelves, and Product

T ffi P tt


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Traffic Patterns

H F t


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Human Factors

R l 4 Id tif V i bl


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Rule 4: Identify Variables

Place sensors nearrepresentative variables!

Adjust ideal “grid” to intersect

variables.


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TOP

FRONT (South Wall)

SIDE


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TOP

FRONT (South Wall)

SIDE


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TOP

FRONT (South Wall)

SIDE


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TOP

FRONT (South Wall)

SIDE


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TOP

FRONT (South Wall)

SIDE

Distance Between Points


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T e m p e r a

t u r e

Distance (X)




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T e m p e r a

t u r e

Distance (X)




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T e m p e r a

t u r e

Distance (1/2X)




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T e m p e r a

t u r e

Distance (1/2X)



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T e m p e r a

t u r e

Distance (1/8X)



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TOP

FRONT (North Wall)

SIDE

Rule 5: If it is worth mapping


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Rule 5: If it is worth mapping…It is worth monitoring.

Find the hot and cold spots and monitor them.

Select the right monitoring solution.

Qualify the monitoring system.

Monitoring


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“Temperature monitoring… documents the temperatures

during the qualification and operation. It allows conclusions onwhether the product is stored and shipped within the approved

temperature range. Therefore, an appropriate temperature

monitoring strategy should be selected and qualified.”

PDA Technical Report No. 58: Risk Management for

Temperature Controlled Distribution (2012)

Monitoring....

Rule Summary


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Rule 1 – Map the Extremes

Corollary 1A – If ≤ 2m3, use 9+1.


Rule 2 - Map in 3 Dimensions

Corollary 2A – If ≤ 20m3, use Stacks of 3

Corollary 2B – Remove Sensors if Possible

Rule 3 - If ≥ 20m3, map storage only.

Rule 4 – Identify Variables

Rule 5 – If it is worth Mapping, it is worth Monitoring

Rule Summary

What about product temperature?


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Its always best to measure air temperature. Worst case scenario provides best challenge.

“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.”

-ISPE Good Practice Guide:

Cold Chain Management (2011)

What about product temperature?

What about mapping humidity?


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The same concepts apply, but concerned with sources of moisture.

Use the same number of sensors unless you have an expert who

understands humidity theory.

“Where relative humidity is a critical factor, then humidity sensors could be

located in the same locations – or fewer locations used with the impact of thetemperature considered for other locations – as absolute

humidity will be very similar throughout the space.”

-ISPE Good Practice Guide:

Cold Chain Management (2011)

What about mapping humidity?

POLL 4:


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Yes, I’m interested in… Loggers

Yes, I’m interested in… Validation Mapping Kit

Yes, I’m interested in… Mapping Services

Yes, I’m interested in… Continuous Monitoring System

Yes, I’m interested in… Process Instrumentation

Yes, I’m interested in… Handheld devices

Yes, I’m interested in… Other

No, thanks.

POLL 4:Do you want Vaisala to contact you?

Summary


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Reviewed Mapping Regulations.

Explored 5 Rules for Sensor Placement for Mapping Storage Areas.

Reviewed Mapping Guidance.

Summary

Thanks for Attending!


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Paul Daniel

Senior Regulatory Compliance Expert

Vaisala, Inc.

Email: [email protected]

Thanks for Attending!

Documents

Vaisala Webinar GxP Sensor Placement Rules 2016