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TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008

Cameroon Version: 1.0


Shipment of dangerous goods/samples Date: April 2015
Page: 1 of 10

Content

1. Scope
2. Definitions and abbreviations
3. Personnel qualifications
3.1 Tasks and responsibilities
3.2 Medical fitness
3.3 Basic education and training
4. Procedure
5. References
6 List of changes to SOP
7. Reading and understanding list

Annex 1. Example of a triple packaging system


Annex 2. Internal shipping form

Compiled by Examined by Approved by Replaced New


Name Numfor Melissa N/A 1.0
Date April 2015
Signature

Laboratory area: No of copies: Reason for change: New SOP


TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 2 of 10

1. Scope
This SOP is to ensure proper and safe transport of all biological materials including
environmental samples such as patients’ specimens, infectious substances, cultures, and
genetic materials for all modes of transportation (air, sea and land) to and from the TBRL
Bamenda.

2. Definitions and abbreviations

Dangerous good: any article or substance which is capable of posing risk to health,
safety, property or the environment.

MSDS – Material Safety Data Sheet


NA - Not applicable

3. Personnel qualifications

3.1 Tasks and responsibilities

Task Responsible Accountable


Packaging and labeling Assigned personnel Principal Investigator
samples to be transported
Receipt of shipped samples Assigned personnel Principal Investigator

3.2 Medical fitness

All lab staff performing this procedure in the TBRL will have access to a free TST. Any lab
staff who exhibit symptoms of TB will be referred for free medical care, including TB
testing and consultation with a doctor. Confidential and free HIV counselling and testing is
available to all lab workers.

3.3 Education and training

All lab staff performing this procedure in the TBRL must have successfully completed training in
the following areas: potential risks to health (symptoms of TB disease and transmission), hygiene
requirements, prevention of incidents and steps to be taken by workers in the case of incidents
(biohazard incidents, chemical, electrical and fire hazards), use of equipment (operation,
identification of malfunctions, maintenance).
TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 3 of 10

4. Procedure
4.1 Samples
Investigational Product samples
Specimens and mycobacterial cultures.
Genetic material
Other hazardous test samples

4.2 Equipment and materials


- 80 freezer
Gloves
Dry ice
TempTale 4 Dry Ice Probe Monitor.
Triple packaging materials
- Labels

4.3 Reagents and solutions


NA

4.4 Detailed instructions for the procedure


4.4.1 Safety precautions

Prior to preparing any dangerous goods/hazardous material for shipment, the Material
Safety Data Sheet is reviewed for safety and emergency response information.

Packages containing dangerous goods are kept in a secured area, under the supervision
of the laboratory director or other authorized employee(s) until picked up by the carrier.

Access is limited to areas where the samples/goods are prepared for shipment,
received, stored, unpacked, or used.

Personnel wear powder-free nitrile gloves while performing the procedures described in
this SOP. Specifically, powder-free nitrile gloves are worn while preparing and handling
sample bottleware and packing samples.

The courier picking up the dangerous goods for shipments is ensured to have
identification (e.g., company ID, wears a company uniform, etc.)

Information concerning hazardous materials shipment is limited to individuals who need


to know. Information on dangerous goods shipment is not shared with casual
acquaintances or strangers.
TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 4 of 10

4.4.2 Transport packaging

The basic packaging system for local surface transport of all samples consists of three
layers (Annex 1):
1. Primary receptacle – the samples are wrapped with enough
absorbent material to absorb all fluid in case of breakage.
2. Secondary packaging – a second durable, watertight, leak
proof packaging to enclose and protect the primary
receptacle(s). Several cushioned primary receptacles may be
placed in one secondary packaging, but sufficient additional
absorbent material must be used to absorb all fluid in case of
breakage.
3. Dry ice is placed outside the secondary receptacle.
4. At the point where the dry ice fills a portion of the box and
the sample is enclosed, press and release the green/left Start
button on the TempTale 4 Dry Ice Probe Monitor. Insert in the
dry ice; record the device name, serial number and expiry
date on the internal shipping form (annex 2).

5. If the monitor has been programmed with a start-up delay, the monitor will not begin
recording data until the start-up delay has passed.

6. Outer packaging – secondary packaging are placed in outer shipping packaging with
suitable cushioning material. This protects the contents from external influences, such
as physical damage during transit.

7. For surface transport there is no maximum quantity per package. For air transport, no
primary receptacle shall exceed 1L for liquids or the outer packaging mass limit for
solids. The volume shipped per package shall not exceed 4L or 4 kg.
8. Every component of the packaging is examined. Packaging materials are not re-used if
packaging exhibit signs of interior or exterior damage

4.4.3 Labelling, marking and documentation.

Packaging of materials for surface transport is labeled clearly with the following
information on the outer packaging;
 Contact name and organization address of both referral and referring
laboratories
 UN Identification Number
 Hazard Class Label(s)
 24 hours emergency contact number of the referring laboratory.
TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 5 of 10

 Documents identifying the contents of the primary receptacle or request forms


are placed outside the secondary package.
 Any documents required by the transporter are accessible without opening the
package.

4.4.4 Documentation and Courier service

Once the material has been packaged and labeled, and you have the shipping
documents completed, complete the shipping form (annex 2) and contact the courier
to arrange the collect.
The courier is assured of the details of what the lab is shipping.

4.4.5 Upon receipt at the lab

When the dry ice shipment arrives,


1. Remove the TempTale Dry Ice monitor.

2. Press and hold (1-3 seconds) the red/right stop button to


manually stop the unit.

3. Verify that the stop sign icon appears on the LCD panel (top
right corner) indicating the TempTale Dry Ice monitor has
been stopped. Note that the “alarm bell” will often appear in the lower right corner of
the LCD display during shipment. This is usually because the temperature starts higher
than -70C.

4. Transfer the boxes immediately to a secure storage area (refrigerator/freezer), at


appropriate temperature and with a monitoring device pre-conditioned at
adequate temperature.

5. Complete the acknowledgement of receipt checklist (attached to package).

6. Complete the reception part of the acknowledgement form and send all
documentation related to the shipment back to the shipper within 2 working days
after the arrival of the shipment.

7. Download the TempTale 4 Dry Ice Probe monitor on the computer PC using the
Interface Plus Reader by placing the monitor in the Interface plus with the LEDs
aligned.

8. Ensure transit temperature is within range. If out of range, follow the procedure
described in the Pharmacy Manual for Study Protocol – EBOLA Z CHAD3-005
(section 12.3.2)

9. Attach temperature monitor print out to internal shipping form and invoice and file.
TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 6 of 10

4.4.6 In case of spills from damaged packing material


The spill is immediately contained in the packing area, and cleaned up appropriately.

Medical advice is obtained any time there is a suspected exposure to infectious


substances resulting from a damaged package.

In the event of exposure to any infectious substance,


1. Move exposed person(s) to a safe isolated area and remove and isolate
contaminated clothing and shoes.

2. The MSDS sheets of the material are refereed for the necessary first aid measures.

3. Call emergency medical services.

4. Generally, in case of contact with the substance, wash or disinfect the affected
area as soon as possible, regardless of the agent. Even if an infectious substance
comes into contact with non-intact skin, washing of the affected area with soap
and water or with an antiseptic solution can reduce the risk of infection. If
exposure to eyes, immediately flush eyes with running water

5. Ensure that medical personnel are aware of the substances involved, and take
precautions to protect themselves.

4.5 Waste management


Any cleaned up spilled material is autoclaved before being taken out of the laboratory.

5. References
1. GLI Stepwise Process toward TB Laboratory Accreditation 2012 (available at
http://gliquality.org/activities/3/10)
2. Pharmacy Manual for Study Protocol – EBOLA Z CHAD3-005, Effective date: 02-Feb 2015
3. TempTale 4 Dry Ice Probe Monitor – Instructions for use
4. World Health Organization (2011) Guidance on regulations for the Transport of Infectious
Substances 2011–2012 WHO/HSE/IHR/2010.8, accessed on March 2015 – at
http://www.who.int/ihr/publications/who_hse_ihr_20100801_en.pdf.
5. World Health Organization (2004) Laboratory biosafety manual, 3rd ed,Geneva.
TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 7 of 10

Annex 1. Example of a triple packaging system


TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 8 of 10

Annex 1. Internal shipping form


TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 9 of 10

6 List of changes to SOP


NB: All changes to be made in any SOP should be written on this page. No changes should be
made directly to the SOP. In the margin, make a note to detailed change described here.
Date Change(s) made Page number Initial(s)
TBRL Bamenda, Standard Operating Procedure (SOP) Code: SOP-P-008
Cameroon Version: 1.0
Shipment of dangerous goods/samples Date: April 2015
Page: 10 of 10

7. Reading and understanding list


I acknowledge reading and understanding this SOP

NAME SIGNATURE DATE

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