Solving GDP Compliance Challenges with Passive … GDP Compliance Challenges with Passive Thermal Cover ... 100 122 133 144 155 166 177 188 199 210 221 232 243 254 Ambient ... •

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



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



1.  EU GDP

3



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



2.  Initial Basics

5



•  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



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



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



3.  Understanding Thermal Performance

9



10

Price Performance



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



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



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



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)



Testing / Qualification – Direct Sunlight Testing

15



Testing / Qualification – Chamber Test Reports

16



4.  Managing Risk –  Establishing the product

temperature limits –  Assessing the supply chain route –  Matching the solution

17



Controlled ambient ranges •  USP guide 20-25C •  EU usually 15-25C •  Reality can be 2-30C / 2-40C

18



•  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



4.  Managing Risk –  Establishing the product

temperature limits –  Assessing the supply chain route –  Matching the solution

20



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



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



23

Time taken to load?



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



4.  Managing Risk –  Establishing the product temperature

limits –  Assessing the supply chain route –  Matching the solution

25



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



•  Situation: –  Air Cargo Pallet –  2-40°C Low risk routes

•  ambient not excessive, •  short duration of temperature exposures

27


•  Example Solution: –  SilverSkin PP150 for air cargo

•  tough, highly reflective, easy to throw over PMC, flexible to follow contour of uneven loads



•  Situation: –  15-25C: Low risk routes

•  ambient not excessive, short duration of temperature exposures

28


•  Example Solution: –  SilverSkin PB500 Double bubble, aluminium

coated •  thicker insulation helps improve performance



29


•  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)



30


•  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



Selecting Solutions – Secondary Protection •  Supporting TCP Pallet Shippers through harsh

ambient to preserve performance

31



Selecting Solutions – Secondary Protection •  Supporting active containers

–  Protecting during loading –  Protecting from any potential dry-ice ‘cold shock’

32



33

Supporting Sea Reefers during dockside during plugging / unplugging (4 to 8hrs)

•  Solution: –  PB500:

•  Double layer bubble, aluminium coated (thicker insulation helps improve performance)



5.  Training Knowledge & Support

34



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



•  Training –  Documentation supplied detailing exact process for fitting

thermal covers –  Video provides visual capability (https://vimeo.com/82086939)

36



Knowledge & Support •  Technical e.g. MKT •  Testing product •  Operational aspects

37



Testing / Qualification

1.  General 1.  Temperature monitor / thermo-couple locations

38



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!!



40

1.  General 1.  Temperature monitor / thermo-couple locations 2.  Dummy product




1.  General 1.  Temperature monitor locations 2.  Dummy product 3.  Mass

41




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



6.  PDA PCCIG Update

43



•  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



7.  Q&A

45



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



• Apendices – USP Quotes

47



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



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



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.

50

Documents

Solving GDP Compliance Challenges with Passive … GDP Compliance Challenges with Passive Thermal Cover ... 100 122 133 144 155 166 177 188 199 210 221 232 243 254 Ambient ... •