The transport of human or animal material intended for diagnosis or examination is regulated by ADR, a UN document that specifies how such substances should be classified, packaged and transported.
Do you transport diagnostic substances safely and legally?
Biological substances in category B must be marked with the UN number UN3373 BIOLOGICAL SUBSTANCE, CATEGORY Beichnet and transported in accordance with the guidelines of packing instruction P650. Our products are tested. The accessories comply with the packaging instructions P650 and have also passed the drop test from a height of 1.2 meters. They stand for the highest quality.
What is UN3373?
When deciding how dangerous goods should be prepared for transport, it must first be decided which UN number the dangerous goods belong to.
There are four UN numbers that are used to classify infectious or biological substances are used:
UN2814 – Infectious substances for humans
UN2900 Infectious substances for animals
UN3291 – Clinical waste UN3373 – Diagnostic substances
UN3373 Medical Bags
What is P650?
If a diagnostic substance has been classified as belonging to UN3373, it must be packaged for transport in accordance with a set of guidelines known as P650 or packing instruction 650. This is a list of requirements that relate to the quality and construction of the packaging used for transport.
Packing Instruction 650 is defined in ADR, the European Agreement concerning the International Carriage of Dangerous Goods by Road . You can find the full text here. Excerpts can be found below.
How can Versapak medical transport bags help you stay compliant?
Versapak worked closely with medical transport staff and in consultation with the Department for Transport (DfT) to develop a range of medical bags that fully comply with this Packaging Instruction 650 whilst being comfortable and user-friendly.
Versapak has supplied bags to approximately two thirds of NHS hospitals, private hospitals and clinics since launching the approved range.
The table below shows extracts from ADR Packaging Instructions P650 in relation to outer packaging and explains how the Versapak medical transport bags can help you comply with Packaging Instruction 650 guidelines.
Packaging instruction 650 required
“The packaging must be of good quality and strong enough to withstand the shocks and stresses normally encountered during transport,…”
Versapak medical bags are made from high quality, weatherproof and tear-resistant material with extra strong stitching. Built-in pads and stiffeners protect the contents.
Packaging instruction 650 required
“Packagings must be constructed and sealed in such a way as to prevent any loss of contents which could be caused by vibrations or by changes in temperature, humidity or pressure under normal transport conditions.”
A sturdy zipper keeps the lid of the bag in place. A tamper-evident closure casing can be closed with a Versapak seal - this seal prevents the bag from being accidentally or secretly opened.
Packaging instruction 650 required
“The packaging must consist of at least three components:
(a) a primary container
(b) a secondary packaging
(c) an outer packaging”
Versapak medical transport bag is the outer packaging. We also supply leak-proof secondary packaging.
Packaging instruction 650 required
“...of which either the secondary or outer packaging must be rigid.”
“Secondary packaging must be secured in outer packaging with suitable cushioning material.”
“Any leakage of the contents is permitted not affect the integrity of the cushioning material or the outer packaging.”
The Versapak medical bag has a stiffener integrated into it, which ensures that the bag remains stable at all times. The stiffener is padded with a soft exterior that protects the contents and improves the user experience. The stiffener, padding and outer material are designed so that any contact with liquid will not compromise their integrity.
Packaging instruction 650 required
“For transport, the symbol shown below must be affixed…” “The correct shipping name “BIOLOGICAL SUBSTANCE, CATEGORY B” must be affixed in letters at least 6 mm high on the outer packaging next to the diamond-shaped symbol.”
An A5 window on the side of the bag is printed with the UN3373 logo. Inside the window, a white card provides a contrasting background and is printed with the appropriate text.
Packaging instruction 650 required
“At least one area of the outer packaging must have a minimum dimension of 100 x 100 mm.”
The smallest of Versapak's diagnostic substance carriers is 305 x 170 x 305 mm.
Packaging instruction 650 required
“The finished package must be able to successfully pass the drop test in accordance with Section 6.3.5.3 in accordance with Section 6.3.5.2 of this Regulation at a height of 1.2 m.”
The Versapak diagnostic carriers have been independently tested and certified to pass a 1.2 m drop test in accordance with these regulations.
Click here for test results.
Primary, inner and outer packaging
A Versapak medical carrier forms the outer packaging for compliance with biological substance category 3373. A primary container is required and is usually specified by the laboratory. We supply Versapak medical carriers with small (6 liters), medium (18 liters) and large (35 liters) internal volumes to suit most laboratory and medical needs. Leak-proof inserts form the inner packaging and are also supplied in small, medium and large sizes depending on the transport company. There are fastening clips attached to the liners which, when used with our absorbent pads, prevent samples from entering the outer packaging.
Please click here to learn more about primary, secondary and tertiary packaging requirements or contact us for more information.
View all of Versapak's approved UN3373 carriers:
UN3373 Medical Bags
