QAD 040176

Temperature Sensitive Rev. 9.1

Products

Subtitle: Handling, storage and shipping requirements for temperature sensitive products

Requester: Sillen Bart

Revision Description of change

First issue. Note: This QAD was registered as number QAD04-0169, because an
A administrative error caused the number to be used for two different issues. New QAD number
QAD04-176 has been assigned.
New instruction for heart valves, Hemotec products, Minimed sensors and Minimed
1.3
implantable pumps.
2.1. Translation from Dutch into English
3.1. Add inspection of “Talent” products
4.1. Remove temperature monitor card for Hemotec products
5.1 Remove penguin label “refrigerate upon arrival” for heart valves
6.1 Add conditions for Melody heart valves
7.1 Add freeze indicators for Hemotec products
8.1 Requirements for shipper box melody valves (par 5.2)
9.1 Include Nanostim products (chapter 10)

1. TABLE OF CONTENTS

1. TABLE OF CONTENTS...........................................................................................................................1
2. PURPOSE ...............................................................................................................................................1
3. REFERENCES ........................................................................................................................................2
4. GENERAL ................................................................................................................................................2
5. HEART VALVES......................................................................................................................................2
6. HEMOTEC ...............................................................................................................................................6
7. MINIMED SENSORS...............................................................................................................................8
8. MINIMED IMPLANTABLE PUMPS (MIP)............................................................................................. 11
9. TALENTS .............................................................................................................................................. 12
10. NANOSTIM ........................................................................................................................................... 13

2. PURPOSE

This QAD should be considered as an overview of the actual procedures and instructions provided by the
respective businesses and document the requirements for handling, storage and shipping of temperature
sensitive products like tissue valves, Hemotec products, Minimed sensors and implantable pumps and
Talents. Procedures and instructions and subsequent updates listed in chapter 3 are provided by the
respective business. Internal work instructions for individual departments involved are to be established
and must refer to this QAD.

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3. REFERENCES

IDENTIFICATION DESCRIPTION
1000066 Shipping instructions, tissue products Heart Valves
1000208 Shipping procedure
030601 Finished goods, handling and storage procedure Hemotec
PC 6212 Shelf life guide line
DOP 115-518 Shipping, finished goods Minimed
ER-98-06-26-1685 Thermal protective shipping system – 10 pack
ER-98-08-24-1754 Thermal protective, 10 pack, shipping system
ER-00-03-13-2396 Qualification of international shipment of glucose sensors using DHL shipper
GQTP 1050 Domestic shipment of glucose sensors
GQTR 1042 International shipment of glucose sensors
WI 105625 Visual Standard for review of TALENT shipping boxes Talents

4. GENERAL

Tissue valves, Hemotec products, Minimed sensors and implantable pumps and Talents must be stored
and shipped under special conditions in order to safe guard tenableness of the products involved and
ensure the high quality standards. Products must be treated with highest priority upon arrival.

5. HEART VALVES

5.1. Storage

Basically valves can be divided in tissue or mechanical valves. Conditions for storing heart valves depend
on the nature of the heart valve as outlined in table 5.1.

Type Model Storage conditions

Contegra 200
Contegra 200 S 15 – 25 °C
Melody
Temperature
Tissue
Controlled
Hancock
Hancock II
5 – 25 °C
Freestyle
Mosaïc

Advantage
No
Mechanical Hall Ambient
restrictions
Hall easy fit

Table 5.1. : Storage condition heart valves

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Prior to booking and subsequent storing of heart valves the temperature monitor card must be checked
as per requirements mentioned in figure 5.1.

OK NOK OK NOK
transparent blue / black grey anthracite

Figure 5.1 : Acceptance criteria for temperature monitor 3M

Tissue valves cannot be booked if they do not contain the required temperature monitor card (one card per
valve) or once the backside of the freeze watch is blue/black or the temperature indicator is black. Once
booked the tissue valves must be placed in a temperature controlled area as per requirements mentioned
on the product label.

5.2. Shipping

Shipping conditions of heart valves are basically related to the nature of the heart valve. Mechanical
valves can be shipped without any precautions and safety measures whereas tissue valves need to be
packed under special conditions as outlined in figure 5.2.

Type Model Shipping conditions

Temperature controlled

Freeze watch inside product

Contegra 200 packaging
Contegra 200 S
Melody Add temperature monitor
card per valve
(item no. : 802465001)
Tissue

Temperature controlled
Hancock
Hancock II
Add temperature monitor
Freestyle
card per valve
Mosaïc
(item no. : 802465001)

Advantage Ambient
Mechanical Hall
Hall easy fit No additional requirements

Tabel 5.2. : Shipping conditions heart valves

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Check the temperature monitor card as per requirements in figure 5.3. and add one temperature monitor
card per heart valve. Biological or tissue valves must be packed on the day of shipping. Products that
cannot be shipped on the same day must be unpacked and refrigerated.

Packaging instruction tissue valves

1. Select the appropriate shipping box and number of gel packs as per table 5.3.

Model Qty Packaging Gel packs

VAL 1
1 6
(item no : 802529001)
Freestyle
Mosaïc
>5 VAL 3 5

VAL 2
Contegra 200 1 10
(item no : 802530001)
Contegra 200 S
Hancock
Hancock II >5 VAL 3 5

Melody ≥1 VAL 3 0

Tabel 5.3. : Shipping box and gel packs for tissue valves

2. For Melody valves VAL3 boxes are to be used regardless of the amount of valves in a shipment.
DO NOT INCLUDE FOAMBRICKS/GELPACKS PUT FILL VOIDS WITH AIR PILLOWS ONLY.
3. Open the shipping box and put the gel packs on the lateral sides of the foam isolation.
4. Check the temperature monitor card as per requirements in figure 5.2., add the card (item no. :
802465001) to the product packaging and put it in the plastic bag subsequently (does not apply for
“Contegra” and “Melody” valves (table 5.2.))

OK NOK OK NOK
transparent purple grey antracite

Figure 5.2. : Acceptance criteria for temperature monitor card

5. Put the plastic bag incl. the product packaging in the shipping box
6. Depending on the packaging type outlined in tabel 5.3.
VAL 1 : Put gel packs on product packaging and close the shipping box using the isolating lid.
VAL 2 : Slip foam cuff round the product packaging and put the entire package in the shipping box
VAL 3 : Put gel packs on product packaging, add fixation materials if necessary and close the
foam box using the isolating lid.
6. Close the shipping box

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a. b. c.

d. e. f.

g. h.

Figure 5.4. : Packaging instruction

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6. HEMOTEC

6.1. Storage

Each shipping box containing catalogue numbers 304-01POR up to and included 304-11POR contains
temperature monitor cards. Check the temperature monitor card as per instructions mentioned in figure
6.1 upon arrival.

OK not OK OK Not OK OK Not OK

groene V blank helder blauw/zwart lichtgrijs antraciet

Figure 6.1. : Acceptance criteria for temperature monitor card

Products cannot be booked to regular stock if the freeze watch (blue/black) and/or temperature monitor
card (anthracite) are activated. If there are no discrepancies all Hemotec products can be booked (use
longest UBD for booking) and stored in a fridge at temperatures between 2°C and 10°C.

6.2. Shipping

When appointing the UBD of Hemotec products both chilled and ambient storage and shipping conditions
have been investigated. Many products contain a UBD 1 (short) for ambient conditions and a UBD 2
(long) for chilled storage conditions. Product can be shipped under ambient conditions if below mentioned
UBD rules are respected.

Product are being removed from the fridge :

a. if date < 10 days of UBD 1 (short) Change UBD 1 in picking date + 10 days

b. if UBD 1 (short) is expired Change UBD 1 in picking date + 10 days

c. if date < 10 days of UBD 2 (long) Contact supply chain dept. and take another lot
number.

Hemotec products must be packed on the day of shipping. Products that cannot be shipped on the same
day must be unpacked and refrigerated.

Packaging materials

Item Description Qty

A15307001 Penguin / refrigerate label (“do not freeze / refrigerate upon arrival”) 3

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Packaging instruction

1. Select shipping box depending on order quantity and volume.

2. Take some fixation materials if necessary, close the shipping box and put three shipping labels (figure
6.2) on the upper side and two lateral sides of the shipping box.

Figure 6.2. : Shipping label Hemotec products

Figure 6.3. : Packaging instruction

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7. MINIMED SENSORS

7.1. Storage

Minimed sensors are very temperature sensitive products and must be treated with highest priority and
refrigerated upon arrival. Once stored in the fridge products can be booked subsequently according
the regular booking instructions.

Instruction

1. Put the shipping box into the refrigerator and remove the gel packs (one shipping box at the time)
2. Check the temperature indicator as per the requirements in figure 7.1. Scrap products immediately if
the indicator turned anthracite.

OK NOK
grey antracite / black

Figure 7.1. Temperature indicator Minimed sensors

3. Label, store and book the sensors according to the regular instructions.

7.2. Shipping

Minimed sensors are very temperature sensitive products and must be shipped under chilled and
isolated conditions. Depending on the order quantity two different shipping cartons can be used.

Packaging materials

Item Description Qty

802506001 Isothermal box A for 1 sensor 1
802507001 Gelpacks (frozen) for box A 2
A15307001 Penguin / refrigerate sticker (“do not freeze”) 3

- Isothermal box B (aluminium) for 10-12 sensoren 1

802507001 Gelpacks (frozen) for box B 8
2216220ET 14 lingual label (“fragile”) for box B 3

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Packaging instructions

Minimed sensors must be packed on the day of shipping. It is not allowed to store sensors outside the
refrigerator without gel packs in an opened shipping box. Products that cannot be shipped on the same
day must be unpacked and refrigerated.

1. Take the appropriate shipping box and put the frozen gel packs in the shipping box.
A. 1 gel pack on the lateral side of the box
B. 4 gel packs on the bottom of the box
2. Remove the sensors from the fridge and check the temperature indicator as per the requirements
in figure 7.1. Scrap products immediately if the indicator turned anthracite.
3. Put product packaging in a plastic bag before putting them in the shipping box.
4. Depending on the shipping box put :
A. 1 gel pack and isolating lid
B. 4 gel packs and fill up if necessary
5. Close the shipping box and put three shipping labels on the upper side and two lateral sides of
the shipping box.
C. Penguin / refrigerate label figure 7.2
D. Multi lingual label figure 7.3.

Figure .7.2. : Label isothermal box (A) Figure 7.3. : Label isothermal box (B)

Small shipper

a. b. c.

d. e. f.

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g. h. i.

Large shipper

a. b. c.

d. e. f.

g. h. i.

j.

Figure 7.4. : Packaging instruction

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8. MINIMED IMPLANTABLE PUMPS (MIP)

8.1. Storage

Implantable Minimed pumps should not be stored in a fridge but are stored under ambient
conditions. Do not put these products in a freezer !!

8.2. Shipping

In order to protect the vulnerable MIP during transport special packaging instructions apply.

Packaging materials

Item Description Qty

802506001 Isothermal box 1
802507001 Gelpacks (room temperature) 2
802465001 Temperature monitor card 1
802528001 Penguin label (“do not freeze”) 3

Packaging instruction

1. Check the temperature indicator as per the requirements in figure 8.1.

OK NOK OK NOK
transparent purple grey antracite

Figure 8.1. : Acceptance criteria for temperature monitor card

2. Open the shipping box and put the gel pack, product packaging, temperature monitor card and gel
pack in the shipping box.
3. Place the isolating lid and close the shipping box
4. Put three shipping labels (see figure 8.2) on the upper side and two lateral sides of the shipping box.

Figure 8.2. : Shipping label implantable Minimed pumps

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9. TALENTS

9.1. Storage

Talent products must be preferably stored under ambient conditions and anyway below 54°C

9.2. Shipping

Prior to processing the temperature indicator on the outrside of the product packaging must be checked
as per the instructions mentioned in figure 9.1.

Not OK Not OK OK
black partly black grey

Figure 9.1. : Acceptance criteria for temperature monitor card

Once exposed to temperatures above 54°C the temperature indicator will change from grey into black
and product needs to be treated as a non conforming product and scrapped at any time.

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10. NANOSTIM

9.1. Storage

Nanostim products are temperature sensitive products and must be stored in a temperature
controlled environment respecting the storage temperature limits as per product labeling.

Figure 10.1. : Nanostim product

9.2. Shipping

Packaging instruction

White box Large Shipper

Figure 10.2. : Product packaging and large shipper box

1. Open the white box and put maximum 10 Nanostim products in the white box.
2. Fill the empty spaces using the air pillows, close and tape the box.
3. Open the printed shipper box and put one “koolite foam brick” on the bottom of the shipper box
4. Put the white box containing the products on top of the “koolite foam brick”.
5. Fill the empty spaces with “koolite foam bricks”
 1 thin one on the longitudinal side of the shipper box
 1 thin one on top of the white product box
 2 thick ones on the lateral sides of the shipper box
6. Plaats ten slotte nog een smallere “koolit foam brick” bovenop het doosje.
7. Put the foam on top of the “koolite foam brick”
8. Close and tape the box and apply the shipping labels.

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a. b. c.

d. e. f.

1. Shipping box
2. White product box
3. Thick “koolite foam brick”
4. Small “koolite foam brick”
5. Products (Nanostim)

Figure 10.3. : Packaging instruction

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