ECX Direct Inc.

Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

OBJECTIVE

1. The purpose of this Work Instruction is to ensure that all ECX’s operation staff understand
their responsibility in managing bulk drug shipping using active RKN containers to maintain
full chain of custody and harmonization

2. The objectives of this guidelines is to harmonize and ensure that

a. Origin ECX office understood the guidelines to manage active RKN

b. Destination ECX office understood what actions are needed when receiving the
active RKN upon flight arrival

SCOPE

3. The scope of this guidelines covers time of activation to delivery of the pharma shipment.

4. The 8 basic stages and actions to be adhered are as follows

Origin Office

 Stage 1 Activation
 Stage 2 Preparation
 Stage 3 Collection
 Stage 4 Lodgment of shipment
 Stage 5 Flight Departure

Destination Office

 Stage 6 Fight Arrival

 Stage 7 Custom Clearance
 Stage 8 Delivery


REASON FOR UPDATE

 ECX Direct Inc. Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

5. Improvement from previous versions and member’s feedback

DEFINITIONS / RESPONSIBILITY

 Shipper - A customer that exports the shipment

 Consignee - A customer that imports the shipment
 Air Operations - ECX air operation staff / Validated partner operations
 Transporter - Transport vendor / ECX that collects / delivers the
shipment
 Transit Warehouse Staff - Transit warehouse vendor / ECX
 Airport Shuttle Provider - Transport vendor / ECX that lodge the shipment
 DTBT - Date / Time / Battery Capacity / Temperature

PROCEDURE

Activation

Task Origin ECX

 Check shipment temperature profile

 Confirm when shipment will be ready for collection

 Check if the RKN can be transported inside the refrigerated storage

Air area
Operations
 Check temperature inside the storage facility where the sample will be
transferred to the RKN

 Check if monitoring devices are installed to indicate the temperature inside

and outside the refrigerated storage facilities

 Check if there are plugs in available to charge the RKN

Exception

 Refer to relevant Work Instruction how to operate the various RKNs

 ECX Direct Inc. Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

Preparation

Task Origin ECX

 Book with the RKN with respective airline

 Collect RKN from airline and log the date/time/battery

capacity/temperature (DTBT)

 Check if the RKN may return at destination airport after delivery

Air
Operations
 Change the RKN to at least 95% battery capacity, take a photo with
date/time.

 Set the required temperature settings and pre-condition according to

RKN operating instruction

 Log DTBT when precondition temperature settings reached defined

settings
 ECX Direct Inc. Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

Exception

 Refer to relevant Work Instruction for pre-condition of various RKNs

Collection

Task Origin ECX

 Log DTBT when RKNs upon arrival and inside Shipper refrigerated
facilities, ensure that there is pallet below the Envirotainer to pallet jack
into or out of the truck when forking into the truck

Transporter  Before transferring the cargo into the RKN log the DTBT before RKN
door

 Ensure that the cargo is placed on top of pallet for airflow beneath. This
is mandatory
 ECX Direct Inc. Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

 Log DTBT when the cargo is completely transferred and the RKN door
is closed

 If RKN cannot be moved inside Shipper refrigerated facilities, place the

RKN as close as possible to the entrance to shorten the distance
during the transfer and record the surrounding temperature outside
Exception
 If the temperature outside is higher than the refrigerated storage
temperature set the RKN temperature to the minimum allowable
temperature range of the bulk drug acceptance, so that the resultant
temperature during transfer would still be with range

 The cargo transfer should be done at the shortest possible time with a
guideline of not more than 10 minutes

 Re-adjust the temperature settings to the correct defined temperature

setting once the temperature reached the correct temperature on the
RKN display

 Log the DTBT

Lodgment of Shipment

Tasks Origin ECX

 Ensure the RKN is power up at the airline terminal pending loading
 ECX Direct Inc. Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

Airport
Shuttle  Log the DTBT
Provider
 Ensure that there is fixture separating the RKN from the ground for ventilation
Exception especially if the RKN is lodge during daylight hours

Flight Departure

Tasks Origin ECX

Airport  Ensure flight took off on schedule with RKN onboard
Shuttle
Provider  Inform destination Import Lead

ETA

Tasks Destination ECX

Air  Log DTBT upon flight arrival

Operation /

Airport  Plug in to power up the RKN and check that the display that it is
Shuttle charging
Provider

 DTBT to be monitored and recorded regular intervals based on

respective airlines SOPs on RKN monitoring sheet
 ECX Direct Inc. Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

 RKN is to be kept in shaded and cool environment away from heat

source

 RKN is remain plug in and charged at all times upon arrival

Exception

Customs Clearance

Tasks Destination ECX

 Record DTBT at regular intervals during custom clearance

 ECX Direct Inc. Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

Air
Operation

 Upon custom clearance completion, log DTBT when RKN is taken over
from airline terminal

 Look thru the record of the DTBT sheet maintained by the airline upon
Exception arrival and do not take possession of the RKN in the event of
discrepancies, notify relevant parties for further instructions.

Delivery

Tasks Destination ECX

 Log DTBT when RKN is handed over to Consignee

 ECX Direct Inc. Standard Operating
Procedure
SOP No. Version Written By Justin Katigbak
Change Date Effective Date Next Review
Title Envirotainer RKN Handling Page 1 of 2

 Take picture of the temperature and battery display before opening the
RKN

Transporter

Air  Request from Envirotainer booking station for temperature data logger
Operations readings of the RKN.

 Envirotainer active RKN temperature download can only be

Exception downloaded by appointed handling agent of Envirotainer at the return
airport location

REFERENCES

6. See Envirotainer Handling Instruction www.envirotainer.com

Prepared By

Justin Katigbak