Hologic ThinPrep 5000, Operator'S Manual

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AW-13653-001 Rev. 001
ThinPrep® Solutions Shipping Requirements *
Scope:
These requirements include shipping:
•
Biological specimens (patient specimens) in ThinPrep ® solutions
• Biological specimens in solutions other than ThinPrep ® solutions
• Biological specimens not in solutions
•
ThinPrep
®
PreservCyt
™
Solution without biological specimens
•
ThinPrep ® CytoLyt ™ Solution without biological specimens
Note: Shippers of Hazardous Materials or Dangerous Goods must be trained according to the
various Hazardous Materials/Dangerous Good regulations
A. Shipping Requirements when shipping patient samples in ThinPrep PreservCyt Solution only –
Ambient Temperature:
1. Patient samples / biological substances (pathogens) contained ThinPrep PreservCyt Solution
are neutralized or inactivated by the solution and as such no longer pose a health risk. (For
further information regarding this, refer to the ThinPrep 2000 or ThinPrep 5000 Operators’
Manual).
2. Materials that have been neutralized or inactivated are exempt from the Category B Class 6,
Division 6.2 requirements.
3. Solutions that contain neutralized or inactivated pathogens, and meet the criteria of one or
more of the other hazards risks, must be shipped according to the shipping requirements for
that hazard risk(s).
4. ThinPrep PreservCyt Solution is a Flammable liquid when shipped domestic or international
Therefore, follow the instructions in Section C below, Shipping ThinPrep® PreservCyt™
Solution Only (such as from a laboratory to a physician).
B Shipping Biological Specimens in Solutions (other than ThinPrep PreservCyt Solution) or
Without Solutions
Definitions:
•
Biological Substance, Category B: Materials containing or suspected to contain infectious
substances that do not meet Category A criteria. IATA Dangerous Goods regulations were
revised with an effective date of January 1, 2015. Note: The term “diagnostic specimen” has
been replaced with “biological substance, Category B”
• Exempt specimens: Specimens that with the minimal likelihood that pathogens are present
(fixed tissue, etc.)
* These instructions are Hologic’s interpretation of the various regulations as of the effective date.
However, Hologic will not be responsible for any non-conformance to the actual regulations.
Notes:
When biological specimens are shipped in a solution of a quantity of 30 ml or less and are
packed in accordance with these guidelines, no further requirements in the Hazardous
Materials (Dangerous Goods) Regulations need be met. However, training is recommended.”
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