Category B Substances Packaging Instructions
Category B substances are infectious but do not meet the criteria for Category A.
Category B infectious substances must be triple-packaged in a watertight primary specimen receptacle, watertight secondary packaging, and outer packaging strong enough to pass a 9 m drop test and 7 kg puncture test.
This section outlines the required steps for transporting Category B Substances to our laboratories. Please consult the IATA website for additional information.
Specimen Collection & Transport
1. Primary Specimen Receptacle
Place each sample in a 95 kPa-tested specimen receptacle that does not allow liquids or solids to leak out (i.e., leak-proof and sift-proof).
The maximum quantity for a primary receptacle is 500 ml or 500 g.
Leave an air space in specimen receptacles containing liquids, such as urine containers.
Using a vacuum-filled tube ensures the presence of air space.
2. Secondary Packaging
Place the primary specimen receptacle inside another 95 kPa-tested container (either flexible or rigid) that is also leak-proof and sift-proof.
If more than one primary receptacle is being placed in the secondary packaging, use bubble wrap or other material for cushioning between the containers.
If secondary packaging is not pre-labeled, add an international biohazard label to the secondary packaging.
Liquid Specimens
Maximum quantity allowed: 1 L per secondary packaging.
Multiple secondary packaging in the same outer packaging is allowed, but maximum quantity of total liquid allowed in the entire package is 4 L.
Note: Add enough absorbent material in the secondary packaging to absorb the total volume of liquid being placed in it.
Solid Specimens
Maximum quantity allowed: 4 kg per secondary packaging, which is also the maximum quantity of total solid allowed in the entire package.
3. Outer Packaging
Place the secondary packaging(s) inside a rigid outer packaging.
If you are reusing a box, please remove or obscure any old labels from previous uses.
The outer packaging must be large enough to hold the secondary packaging(s) and correctly display the required external packaging markings and transport documents, such as the shipping label. At least one surface of the outer packaging must be 4 × 4 inches.
The total maximum quantity for a package containing Category B infectious substances is 4 L (liquids) or 4 kg (solids).
4. Requisition
Place a completed Cleveland Clinic Laboratories Test Requisition in the outer packaging.
Be sure that the requisition is placed outside of any secondary packaging to avoid contamination during transport.
Download a fillable PDF or place an order for hard copies on the Supply Storefront.
Requisitions ordered from the Supply Storefront are printed in duplicate, and can be ordered in sets of 25.
5. Category B Packaging Markings
Place the markings for a Category B infectious substance on the outer packaging.
Pre-labeled outer packaging and Category B Substance labels can be ordered from our Supply Storefront or purchased from multiple vendors.
The sides of the diamond shape must be at least 50 mm in length and at least 2 mm thick.
The height of the letters and numbers of the marking must be at least 6 mm.
6. Emergency Contact Information
Include the name and phone number (including area code) of an emergency contact from your facility on the outer packaging.
This information can be provided as part of the return address or as a separate package notation.
This designated emergency contact person is accepting responsibility to be available during the regular business hours of your facility to provide accident mitigation information in case the package is damaged or the specimen leaks during transit.
7. Shipping Label
Complete a shipping label with the required information.
Attach the completed label to the outer packaging according to the guidelines of the carrier being used for shipping.
Review our Specimen Transport Guidelines for more information.
Additional Category B Substance Shipping Information
Packaging kPa Compliance
Primary and secondary packaging must be 95 kPa compliant (rated to withstand an internal pressure differential of 95 kilopascals).
• Vacuum-filled receptacles (e.g., blood collection tubes) generally meet 95 kPa; however, check with the manufacturer to ensure that they meet the requirement.
• Flexible secondary packaging is usually labeled “95 kPa” by the manufacturer.
• For rigid containers, check the manufacturer’s website or product inserts to ensure compliance.
Transportation Regulations
All applicable laws of the United States Department of Transportation must be complied with when shipping any specimen.
Ground transportation: Specimens via ground transportation can be shipped using the Code of Federal Regulations (CFR) Title 49.
Air transportation: When shipping via air transportation, there are more detailed instructions found in the International Civil Aviation Organization (ICAO) technical instructions, or the more commonly used International Air Transport Association (IATA) regulations. Either set of regulations is compliant with the Federal Aviation Administration (FAA).
Packaging Drop Test Requirements
Completed packages must be capable of successfully passing a drop test described in the regulatory documents: DOT Hazardous Materials Regulations and IATA Dangerous Goods Regulations.
Packaging meeting these requirements can be ordered online through our Supply Storefront or can be purchased from multiple vendors.
Training
Anyone performing a function that causes a hazardous material to be placed in public transportation is required to be trained in accordance with the Code of Federal Regulations (CFR) Title 49, part 172.704.
Cleveland Clinic Laboratories offers online courses for those in need of training and certification in specimen transportation. Please contact your account representative for more information.
Maximum Amount of Contents in Package
The total maximum quantity for a package containing Category B infectious substances is 4 L (liquids) or 4 kg (solids).