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Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Speaker: Peter Lockett, Co-Founder & Global Engineering COO TP3 Global Helping the healthcare supply chain sector protect temperature sensitive freight
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Agenda 1. EU GDP 2. Some Basics 3. Understanding Thermal Performance
of Thermal Covers 4. Managing Risk 5. Training, Knowledge & Support 6. PDA Paper – Update 7. Q&A
2
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
1. EU GDP
3
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
EU GDP requirements in relation to thermal covers • Chapter 9. Transportation - 9.1. Principle
– It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport
– Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. A risk-based approach should be utilised when planning transportation.
4
Source: Commission guideline 2013/C 343/01 - http://ec.europa.eu/health/human-use/good_distribution_practice/index_en.htm
1. Help regards understanding thermal cover performance
2. Help regards
managing risk
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
2. Initial Basics
5
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
• Temperature control verses temperature protection – Control: when passive and active containers are used to keep
product between temperature for a certain duration • E.g. Envirotainer or Temperature Controlled Packaging keeping
product between 2-8°C (36-46°F) for 72hrs. – Protection: when passive equipment is used to act as a
barrier between the temperature threat and the product. This doesn’t stop temperature movement, it simply slows it down enough to enable operations
• E.g. Thermal covers being used over pallets of controlled room temperature product to be kept between 2-40°C (36-104°F)
6
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Cost of Protective Equipment
Per
form
ance
– T
empe
ratu
re D
evia
tion
e.g. ~$30 e.g. ~$3000 e.g. ~$300
Nar
row
Dev
iatio
n W
ide
Dev
iatio
n
Active Containers
€1000 p/day?
€200-€1000? Qualified Packaging
€100 - €500? Thermal Blankets
€30 - €100?
Thermal Covers
Thermal Protection Equipment Hierarchy
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Some initial basics… • Terminology
8
Shroud Wrap
Quilt Blanket
Jacket
Hat
Cap
Cover Usually single / limited use
Highly reflective Lower cost
Blanket Usually multi use
Higher levels of insulation Higher cost
Quilt Usually multi use
Higher levels of insulation Cross stitched design
Higher cost
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
3. Understanding Thermal Performance
9
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
10
Price Performance
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Performance Expectations
11
Ambient Active Container Passive TCP EPS Only Thermal Cover
25
35
15
5 0 -5
-15
45
Tem
pera
ture
(Cen
tigra
de)
Ambient Thermal Cover
e.g. 4hrs airport ramp
EPS Only
Passive TCP
Active Container
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Factors Affecting Performance 1. External
– Ambient temperature – Direct sunlight / shade – Temperature
differential – Ground heat – Wind chill
2. Internal – Product type & mass – Volume – Packaging – Conditioning – Type of protection – Integrity of protection
12
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Factors Affecting Performance - Mass
13
0
5
10
15
20
25
30
35
40
45
50
0 20
40
60
80
100
120
140
160
180
200
220
240
260
280
300 0
5
10
15
20
25
30
35
40
45
50
0 20
40
60
80
100
120
140
160
180
200
220
240
260
280
300
Empty Mass Full Mass
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Affecting Performance – Load Size
14
0
10
20
30
40
50
60
1 12
23
34
45
56
67
78
89
100
111
122
133
144
155
166
177
188
199
210
221
232
243
254
Ambient Direct Sunlight 020
PH300 Large, Top & Base, Under Cover 014
PH300 Small, Top & Base, Under Cover 018 Te
mpe
ratu
re
(Cen
tigra
de)
Time (Minutes)
38 minutes (doubled protection)
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Testing / Qualification – Direct Sunlight Testing
15
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Testing / Qualification – Chamber Test Reports
16
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
4. Managing Risk – Establishing the product
temperature limits – Assessing the supply chain route – Matching the solution
17
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Controlled ambient ranges • USP guide 20-25C • EU usually 15-25C • Reality can be 2-30C / 2-40C
18
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
• USP Controlled Room Temperature – Specifies 20-25C / 68-77F – Allows for excursions 15-30C / 59-86F – And excursion up to 40C not over 24hrs
• as long as MKT not over 25C
19
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
4. Managing Risk – Establishing the product
temperature limits – Assessing the supply chain route – Matching the solution
20
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Relevance of chamber and outdoor testing • Chamber testing helps understand protected parts of
supply chain • Outdoor tests help understand break in supply chain
21
Chamber Trail Relevant Chamber Trail Relevant Outdoor Test
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Main Cause of Temperature Spikes – The Airport Threat
0.5km
1km 2km 3km 4km 5km 6km
Frankfurt Airport: A main hub for cargo traffic globally. At around 6km long and 4km wide.
Frankfurt Airport: It could take hours to tractor cargo from the cargo centre to the aircraft
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
23
Time taken to load?
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
24
25°C
15°C
Ramp ~2hrs
Flight ~5.5hrs
Ramp ~3hrs. Max Temp 33°C
Flight ~3hrs
8.40hrs
Ambient Temperature
Temperature Under SilverSkin PB500 Cover
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
4. Managing Risk – Establishing the product temperature
limits – Assessing the supply chain route – Matching the solution
25
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
26
Selecting Solutions – Primary Protection
• Situation: – Skid Size Pallet – 2-25°C Low risk routes, with allowances
• ambient not excessive • short duration of temperature exposures
• Example Solution: – SilverSkin PP100 or PH300 top, optional base
• easy fit, flexible and moldable material to fit around uneven and odd size loads
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
• Situation: – Air Cargo Pallet – 2-40°C Low risk routes
• ambient not excessive, • short duration of temperature exposures
27
Selecting Solutions – Primary Protection
• Example Solution: – SilverSkin PP150 for air cargo
• tough, highly reflective, easy to throw over PMC, flexible to follow contour of uneven loads
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
• Situation: – 15-25C: Low risk routes
• ambient not excessive, short duration of temperature exposures
28
Selecting Solutions – Primary Protection
• Example Solution: – SilverSkin PB500 Double bubble, aluminium
coated • thicker insulation helps improve performance
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
29
Selecting Solutions – Primary Protection
• Situation: – 15-25C: Medium risk routes
• ambients more excessive, short duration of temperature exposures
• Example Solution: – PB500 Quattro:
• Four layer bubble, aluminium coated (thicker insulation helps improve performance)
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
30
Selecting Solutions – Primary Protection
• Situation: – 15-25C: Higher risk routes
• medium ambient, medium duration of temperature exposures
• Example Solution: – SilverSkin ML15
• thick 40mm / 1.5” multi-layer material designed for higher thermal performance
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Selecting Solutions – Secondary Protection • Supporting TCP Pallet Shippers through harsh
ambient to preserve performance
31
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Selecting Solutions – Secondary Protection • Supporting active containers
– Protecting during loading – Protecting from any potential dry-ice ‘cold shock’
32
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
33
Supporting Sea Reefers during dockside during plugging / unplugging (4 to 8hrs)
• Solution: – PB500:
• Double layer bubble, aluminium coated (thicker insulation helps improve performance)
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
5. Training Knowledge & Support
34
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
EU GDP requirements in relation to thermal covers • Chapter 2.4: Training
– Personnel dealing with any products which require more stringent handling conditions should receive specific training. Examples of such products include hazardous products, radio- active materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products.
35
Source: Commission guideline 2013/C 343/01 - http://ec.europa.eu/health/human-use/good_distribution_practice/index_en.htm
3. Help regards training knowledge & support
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
• Training – Documentation supplied detailing exact process for fitting
thermal covers – Video provides visual capability (https://vimeo.com/82086939)
36
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Knowledge & Support • Technical e.g. MKT • Testing product • Operational aspects
37
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Testing / Qualification
1. General 1. Temperature monitor / thermo-couple locations
38
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
1. General 1. Temperature monitor / thermo-couple locations
39
0 5
10 15 20 25 30 35 40 45 50
1 16
31
46
61
76
91
106
121
136
151
166
181
196
211
226
241
256
271
286
301
316
Small Pallet Innr Bottom 014 Small Pallet Inner Top 015 Small Pallet Outer Top 016 Ambient -024
40 mins
114 mins
Testing / Qualification Super Important Monitor ambient!!
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
40
1. General 1. Temperature monitor / thermo-couple locations 2. Dummy product
Testing / Qualification
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
1. General 1. Temperature monitor locations 2. Dummy product 3. Mass
41
Testing / Qualification
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Operational Aspects
1. Stock • Manufacturing lead times
• Shipping
– Cost
– Time
2. Storage space required
3. Ease of fitting (time, labour)
4. Location of fitting / conditioning
5. SOPs / Training
42
global availability = reduced vendor qualification
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
6. PDA PCCIG Update
43
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
• Upcoming PCCIG technical report on Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance – TCP & Thermal Cover use – Guide on various types of cover – Testing process – Operational guide
• Plan – Initial draft complete – Presented to PCCIG board – Expecting to release mid 2015
44
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
7. Q&A
45
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
Thank you Peter Lockett, Co-Founder & Global Engineering COO TP3 Global +44 789 6469109 pl@tp3global Website: www.tp3global.com Twitter: https://twitter.com/tp3global YouTube: www.youtube.com/user/TP3global Vimeo: http://vimeo.com/tp3 LinkedIn: https://www.linkedin.com/company/tp3-global-ltd
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
• Apendices – USP Quotes
47
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
USP 33–NF 28 Reissue - General Notices and Requirements Section 10.30.60. Controlled Room Temperature • “Controlled room temperature” indicates a temperature maintained thermostatically that
encompasses the usual and customary working environment of 20° to 25° (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°; and that allows for excursions between 15° and 30° (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40° are permitted as long as they do not exceed 24 hours. Spikes above 40° may be permitted if the manufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “up to 25°”, or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value.
48
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
USP 33–NF 28 Reissue - General Notices and Requirements • An article for which storage at controlled room temperature is directed may,
alternatively, be stored and distributed in a cool place, unless otherwise specified in the individual monograph or on the label.
10.30.30. Cool • Any temperature between 8° and 15° (46° and 59°F) is “cool.” An article for which
storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.
49
http://www.mhra.gov.uk/home/groups/comms-ic/documents/publication/con007569.pdf
Silverskin � Thermal Covers for Healthcare Logistics, © Copyright 2014 TP3 Global. www.tp3global.com
Solving GDP Compliance Challenges with Passive Thermal Cover Protection
USP 33–NF 28 Reissue - General Notices and Requirements Section 10.30.40. Controlled Cold Temperature • “Controlled cold temperature” is defined as temperature maintained thermostatically between
2° and 8° (36° and 46° F), that allows for excursions in temperature between 0° and 15° (32° and 59° F) that may be experienced during storage, shipping, and distribution such that the allowable calculated mean kinetic temperature is not more than 8° (46° F). Transient spikes up to 25° (77° F) may be permitted if the manufacturer so instructs and provided that such spikes do not exceed 24 hours unless supported by stability data or the manufacturer instructs otherwise.
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