Shipping of Dangerous Goods and Hazardous Materials
Multi-center Clinical Trials (Industry Sponsored or Investigator Initiated) often utilize a Central Laboratory to evaluate blood and culture specimens collected by the Principal Investigator and/or their staff during the course of the study. The TU Environmental Health and Radiation Safety Department (EHRS) does have University Policies for the Handling and Shipment of Dangerous Goods and/or Hazardous Materials. Please see the Radiation Safety Training matrix to ensure that your training requirements are complete. Two more common training requirements for individuals collecting human blood and cultures during a clinical trial and shipping the specimen to a central laboratory are listed below.
Radiation Safety Training Matrix - Complete list of training programs offered by EHRS that includes Radiation Safety, Hazardous Drug Safety and others that may be relevant to your research at Temple University.
Any Temple University employee who prepares or handles Dangerous Goods/Hazardous Materials (Dry Ice,, Infectious Substances, etc.) for shipment must complete the University Training and Certificate Program conducted by Environmental Health and Radiation Safety (EHRS) Department of Temple University. Employees who are new to shipping must be trained within 90 days of starting to ship. During this time they must be directly supervised by a trained and knowledgeable employee. A Certificate is provided after successful completion of this training. The certification is good for 2 years.
When a new Clinical Trial is started, the Principal Investigator and research staff are also trained by the sponsor regarding on the procedures for collecting, preparing, shipping, and storage of specimens specific to the trial being conducted. This training is specific to the protocol and does not satisfy the Institutional and Federal Regulations for Shipping Dangerous Goods/Hazardous Materials. The information on this web-site information also does not satisfy the training requirement and is intended to provide a general overview to staff seeking information.
The training conducted by EHRS is a Temple University requirement and is also mandated by Federal and International laws. The EHRS provides this training free of charge for Temple employees. Training can be arranged by calling the Program Coordinator at 215 707-2520.
Training Slides presented by Environmental Health and Radiation Safety
DANGEROUS GOODS & HAZARDOUS MATERIAL BASIC DESCRIPTION
The US Department of Transportation (DOT) is the primary federal government division that regulates Dangerous Goods/Hazardous Material transport in the USA. The Department of Transportation Recognizes 9 classes of Dangerous Goods.
Most frequently used classifications used in multicenter Industry funded Clinical Trials without radiation:
For more information you may always access the EHRS web-site or call the department.
Class #6 - Shipping Division 6.2 Biological Materials
Effective October 1, 2006, the DOT has switched to a two-tiered system to identify Class 6.2 infectious materials. Infectious materials will now become either a Category A Infectious Substance or a Category B Infectious Substance, depending on the severity of disease caused upon exposure.
Category A Infectious Substances (UN 2814): are pathogens transported in such a form that they are capable of producing permanent disability or life-threatening disease or death, upon exposure to healthy humans or animals. These will be determined either by using an indicative list of pathogens from DOT or by using scientific knowledge to determine if the pathogen fits the definition above. For Examples of Category A Infectious Substance (click here and go to page 3 of the document (actual page 32245) - as designated by scientist at WHO and the U.S. Department of Health and Human Services (HHS). Please note this list is not all inclusive and is provided only as guidance. Note also that many of the entries on this list include the modifier "cultures only".
Category B Infectious Substances "Biologic Substance, Category B"- (UN 3373) can produce disease but these will not cause permanent disability or threaten life. Many shipments previously called Diagnostic Specimens will now be called “Biological substance, category B”. Please discontinue use of the proper shipping name “Diagnostic Specimen”.
NEVER ship dry ice in an airtight container!!! As it warms it produces vapor, which will cause an explosion in an airtight container.
Ice or Dry Ice outside the secondary recepticle or in an overpack with interior supports that secure the secondary packaging.
TRIPLE PACKAGING SYSTEM USED FOR MANY CLASS 6.2 SUBSTANCES
(Many industry funded trials the sponsor provides the packaging for shipping the materials-you should always call EHRS if you have any questions or concerns!)
Primary Receptacle - A labeled, primary watertight, leak-proof receptacle containing the specimen. The receptacle is wrapped in enough absorbent material to absorb all fluid in case of breakage.
Secondary Receptacle - A second durable, watertight, leak-proof receptacle to enclose and protect the primary receptacles. Several wrapped primary receptacles may be placed in one secondary receptacle. Sufficient additional absorbent material must be used to cushion multiple primary receptacles.
Outer Shipping Package - The secondary receptacle is placed in an outer shipping package which protects it and its contents from outside influences such as physical damage and water while in transit.
Specimen Data Forms - Letters and other types of information that identify or describe the specimen and also identify the shipper and receiver should be taped to the outside of the secondary receptacle.
The basic rule for shipping papers is that if you transport any quantity of hazardous material, a properly prepared shipping paper must accompany the shipment. This includes materials indentified as hazardous substances, hazardous wastes, and marine pollutants. Each person who offers a hazardous material for transportation must accurately describe the hazardous material on the shipping paper in the manner required by HMR.
A shipping paper for hazardous materials is any document that contains the information required to describe the hazardous material being transported. The description must conform to the following requirements:
Legibility
Codes and Abbreviations
Additional Information
Multiple Page Shipping Papers
Emergency Response Telephone Number
Documents and Forms
EMERGENCY CONTACT REQUIREMENT
Temple University has a contract with InfoTrac to do this. This emergency contact informatioin is listed on your billing papers and a fax copy of the shipping papers MUST be sent to Infotrac
.
Telephone number is (800) 535-5053.
Fax number is (352) 326-3902.
REGISTER YOUR SHIPMENT WITH TEMPLE UNIVERSITY
This step is critical to successfully ship your package from Temple University
The notification of dangerous goods shipment form (electronic format) must be submitted to EHRS for each package you ship. This information is vitally important to provide EHRS a brief description of the material you are sending. This allows EHRS to have information in case of an emergency or other circumstance.
Fax a copy of the shipment form to Infotrac (352-326-3902).
Infotrac is the Emergency Contact Information (24-Hours) listed on the Shipping Forms.
"Markings" Mirror the information on the shipping papers- When you offer a hazardous material for transportation in a non-bulk packaging, you must mark the package with the required information for the material. The required information includes
Proper Shipping Name
Identification Number
Technical Names
Exemption Information
Consignee or Consignee's name and address
"Labels" Provide Information about the hazards of the shipment. In most cases you must affix each label required by the HMR to a surface of the package or containment device containing the hazardous material.
CONTACTING THE COURIER
You must contact the Courier to schedule a pick up of your package. The courier services have different pick up times and requirements. For additional information refer to your Laboratory Manual provided by the sponsor or call the courier service directly.
For security and quality assurance purposes packages must not be left at a Drop Boxes placed throughout the University.
FedEx - Fed Express final pick up at Temple University can be up to 7:00 P.M.
DHL - Call in the morning and the last pick up time is 2:30 P.M.
Quest Diagnositic Laboratory - Quest Laboratories has pick up boxes throughout the University that can be utilized. Contact Quest Diagnostic Laboratory for coordination.
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