Safe Transportation of Pico-Cylinders
The medical device market often involves domestic and international shipping of products and components. Understanding the numerous shipping regulations is crucial knowledge for any company hoping to operate on a domestic or international scale. Within the scope of Picocyl, there are regulations regarding the transport of compressed gas cylinders by land, sea, and air. This paper aims to outline the proper method for labeling and shipping small compressed gas cylinders or “pico-cylinders” such that all federal and international regulations are upheld.
TABLE OF CONTENTS
There are three main recognized agencies that are responsible for the regulation and transport of hazardous materials. These agencies are the Department of Transportation (DOT), the International Air Transport Association (IATA), and the International Maritime Organization (IMO). These agencies regulate transportation by land, air and sea respectively. Each organization has its own set of standards regarding the transportation of dangerous goods and compressed gas cylinders.
This whitepaper will outline the applicable requirements, for packages containing Picocyl’s Pico-cylinder products, to comply with the various regulations laid out by the DOT, IATA, and the IMO; and provide Picocyl’s customers with a set of guidelines to follow when labeling their packaging for shipping.
The Department of Transportation, International Air Transport Association, and the International Maritime Organization each have a unique set of guidelines that they reference when regulating the transportation of various goods and materials. These are legal documents that explicitly detail the proper way to transport and label goods. While each agencies’ rules differ slightly, all three reference the Dangerous Goods List and base their regulations for all compressed gas cylinders off of this list. Within all three organizations, the determining factor regarding labeling of a package containing compressed gas cylinders is the water volume of those cylinders. Water volume is a term used to describe the maximum volume of an incompressible fluid that could occupy the internal volume of a receptacle in question.
In general, compressed gas cylinders are considered dangerous, however, depending on its size and the gas type contained within, the risk can be considered low. Due to this, there are exceptions in which labels, such as the limited goods and excepted quantity labels, can be used to allow for easier shipping and ensure that small volumes of gas comply to international regulations. Picocyl currently only produces cylinders containing class 2.2 gases which are defined as non-flammable and non-toxic and thus Picocyl products can be shipped with an Excepted Quantity label present on the packaging.
For Picocyl’s Pico-Cylinders to be shipped under Excepted Quantity, there are several requirements that must be met. The following provisions apply to Excepted Quantities of gas cylinders charged with Division 2.2 non-flammable, non-toxic gases shipped by land, air and sea:
- The maximum quantity per inner receptacle is limited to 30 mL water capacity (1.8 cubic inches)
- The maximum aggregate quantity of hazardous material must not exceed 1L (61 cubic inches) per package
- Receptacles constructed of metal are authorized
- If the inner receptacle has a removable closure, it must be held securely in place with wire, tape or other positive means
- All inner receptacles must be securely packaged inside an intermediate packaging with cushioning material, then placed inside a strong, rigid outer packaging that will withstand normal conditions of transport
- The completed package must be capable of sustaining the following drops from a height of 1.8 m (5.9 ft) onto a solid, unyielding, flat and horizontal surface without any leakage of any inner packaging and without substantial reduction in its effectiveness:
- One drop flat on the bottom
- One drop flat on top
- One drop flat on the long side
- One drop flat on the short side; and
- One drop on a corner at the junction of three intersecting edges
- The completed package must also pass a compressive load (stacking test)
- Minimum height of the stack (including the test sample) must be 3 m (10 ft) high for a duration of 24 hours. The weight of each box used in the stack testing must be the same weight as the test sample box
- The package must not be opened or altered until it is no longer in transport
Each completed package must be marked on the outside with the Excepted Quantity mark with minimum dimensions of 100 x 100 mm. It must include the division number (2.2) of the gas and the name of the shipper or consignee (unless located elsewhere on the package).
A division 2.2 gas is defined in the US Code of Federal Regulations as a non-flammable, non-toxic compressed gas. At the time of writing, all Picocyl products contain division 2.2 gases and as such can be labeled with the Excepted Quantity placard. All of the gases used at Picocyl fall under the E1 category on the E-code table.
Pico-Cylinders and Excepted Quantities
Picocyl makes a variety of compressed gas cylinders whose volumes range from 0.16 to 4.5mL.
Using these volumes in conjunction with the UN Dangerous Goods List, Table 1 was generated to provide the total number of allowed cylinders per package depending on the internal volume.
The formula used to calculate the total number of cylinders allowed under the excepted goods label is shown in Equation 1 below:
For transport by ground within the United States, the excepted quantity label is sufficient when shipping an allowed number of cylinders within a package. For transport by air or sea, the IATA and the IMO require some additional labeling when shipping compressed gas cylinders.
The IATA states that when an Air Waybill is provided, the following wording must appear within the box titled “Nature and Quantity of Goods”:
- “Dangerous Goods in Excepted Quantities” and indicate the number of packages (unless these are the only packages within the shipment)
- No additional marks, labels, placards, or a shippers declaration apply to air shipments of excepted quantities.
The IMO has the following regulations:
- There is a limit of 1000 packages of dangerous goods in excepted quantities permitted in any cargo transport unit (shipping container).
- A shipper’s declaration is required. The following wording must be added to the dangerous goods description “dangerous goods in excepted quantities” and the number of packages. Here is an example excerpt of this documentation.
No additional marks, labels, placards, or a shippers declaration apply to air shipments of excepted quantities.
The world of national and international shipping laws can be a daunting place, however, thanks to the compact design of Picocyl Pico-Cylinders, many of the more stringent shipping laws do not apply. This means that a business using Picocyl technology only needs to consider the application of the Excepted Quantity labels in order to legally ship Pico-Cylinders potentially saving considerable packaging costs. This is just one of the ways Picocyl is pursuing its goal to bring to market new products and solutions which solve today’s and tomorrow’s medical and specialized high-quality application delivery system challenges.
For additional information regarding shipping Picocyl Pico-cylinders, email firstname.lastname@example.org .