Archive from the Spring 2002 semester.

Biomedical Engineering
Design Projects

Product Design Specification (PDS)

Version 4


Tissue Sample Preparation Device for Biochemical Analysis
Version 4 - May 5, 2002
Team Members:
Sara Alford
Christine Koranda
Carla Maas
Ryan Roth
Client: Jeff Ross and Charles Tessier
UW - Medical School
Department of Oncology
Advisor: Mark Nicosia

Function: The device will freeze a tissue sample with liquid nitrogen, grind it into a fine powder, and collect it in a small vial ready for further biochemical analysis. The device will replace the manual mortar and pestle grinding technique currently used.
Client Requirements:
· Sample and tools used must be kept cold at all times during the process
· Must salvage as much as tissue sample as possible
· Processing time should be similar to that for manual preparation (approximately 15 minutes)
· Device to be used for 30-40 samples/day
· Grind tissue to the consistency of powdered sugar

Design requirements:
1. Physical and Operational Characteristics

a. Performance requirements: Tissue should be easily inserted into the device. After grinding completion, tissue sample should be removed and grinding area cleaned before the next sample. Device will be in operation 3 - 5 hours per day. On average the device may have to be turned on 1 -3 times per day.

b. Safety: Liquid nitrogen should not be exposed to flesh or clothing. Instrument may be cold to touch. Cryogenic gloves and safety glasses may be required for the use of the device.

c. Accuracy and Reliability: Technique should grind sample to a powdered-sugar consistency. Collection method should gather the majority of the sample (or at least 38 mg) in the vial.

d. Life in Service: It will be used 5 days a week throughout the year, lasting at least that year. Around 30-40 samples will be analyzed daily.

e. Shelf Life: Stored on a laboratory bench at room temperature indefinitely (possibly several years).

f. Operating Environment: Device would function in a normal room temperature (approximately 20°C) biochemistry laboratory. Alternative to laboratory bench storage may be storing the entire device or certain components in a -20 or -80°C freezer. The interior will be exposed to extremely cold (-196°C) temperatures. The exterior may be exposed to freezer conditions (-20 or -80°C). The device will be handled by laboratory technicians.

g. Ergonomics: Sample should be easy to insert, and the user's hand should not be subjected to a cold temperature when inserting the sample.

h. Size: The device should fit on a laboratory bench with a maximum volume of 0.91x0.61x0.61 m (3x2x2 ft).

i. Materials: Only materials that can be subjected to extremely cold temperature such as metal or Pyrex glass should be used. Regular glass and plastic should be avoided.

j. Cleaning: The components of the device that come in contact with the sample should be removable for ease in cleaning and disinfecting (soap and water).

2. Production Characteristics
a. Quantity: One prototype will be constructed.

b. Target Product Cost: If a pathology lab were to purchase the device, a reasonable range would be $5,000 - 20,000. For our client's biochemistry laboratory, a reasonable cost for the prototype is $1,000 - 1,500.

3. Miscellaneous
a. Standards and Specifications:
Premarket approval by the FDA will be required.

b. Competition:
· Polytron system - a homogenizer that operates at room temperature to grind up sample.
· Biospec BeadBeater - uses glass or stainless-steel balls to break apart sample, operates at room temperature.
· Biospec Cryogenic Pulverizer - uses hammer to crush pre-frozen sample in mortar.
· Jet Pulverizer - use air pressure to pulverize sample.





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Owner: Willis Tompkins, Ph.D.
Author: Carla Maas
Created: 05/03/02
Content updated: 05/03/02

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