Analytical Technician Homework Assignment

Scope: While we do not anticipate that you will have time to meet the requirements of all approaches listed above, we would at a minimum like to see within the time provided how you would approach the assignment and what you can accomplish.

Deadline: Please spend no more than twenty four $(24)$ hours working on this assignment. Submissions are required twenty four $(24)$ hours from when the homework assignment is sent. Please do your work in a google doc so that, if we choose, we can review the timeline.

Work: Please complete your answers in the answers section at the bottom of this assignment. All sources used should be documented. Make sure to leave edit history on$.$

Product Details:

We are in the process of creating a device that aims to keep you caffeinated at the ideal levels at the ideal times of the day. This implantable device has ten $(10)$ threads that react with different biomarkers to detect energy and caffeine levels within the body to create a customized caffeine consumption plan for you. It will alert your phone when it is time to consume more caffeine. It will detect when you have consumed too little or too much caffeine.

Device Specifications:

Surface area: $100c{m}^2$

Weight: $500g$

Device packaging will be made of polychlorotrifluoroethylene $($PCTFE$).$

Device Manufacturing:

Device will be manufactured using numerous inorganic and organic manufacturing agents

Device will go through final cleaning in isopropyl alcohol

Device will be manufactured by sterile technicians

Final device will be sterilized with Ethylene Oxide

Questions:

To test device safety, an extraction must first be performed. Describe an approach for extracting residual manufacturing agents, handling solutions, and concentrating solutions with a focus on minimizing device or extract contamination and maximizing extraction of representative agents from the device.

What are common sources of contamination in high resolution mass spectroscopy? How would you avoid them?

You're performing a study to determine the extractable composition of a medical device. Prior to injection, you notice that your extracts contain solid residue at the top of the test tube. Describe how this observation may impact the final study if you proceed as$-$is$.$ Additionally, explain how you might mitigate risks associated with this observation.

You are developing a headspace GC$-$MS method to detect residual manufacturing agents on the device and need to create a calibration curve using limited resources. Draft a dilution plan to prepare standards for calibration. Explain any potential advantages or disadvantages associated with your choice of dilution plan. The calibration curve must contain $7$ points and range from $0\mathrm{.}25ppm$ to $20ppm$ and the minimum volume for analysis is $2mL.$ The standard stock solution provided is $1mL$ at $2000ppm.$ Below is a list of available volumetric flasks, pipettes, and vials:

$4\mathrm{.}1.,1-10mL$ pipette

$4\mathrm{.}2.100-1000uL$ pipette

$4\mathrm{.}3.10-100$ uL pipette

$4\mathrm{.}4.610mL$ volumetric flasks

$4\mathrm{.}5.65mL$ volumetric flasks

$4\mathrm{.}6.4$ dram vials

$4\mathrm{.}7.10$ dram vials

You are reviewing ICP$-$MS data generated by another analyst which tests for $Na,Ca,K,Fe,Ni,Cr,Ti,Cu,Al,Zn,B,Cd,Cs,$ and $Rb.$ Linearity and spike recovery is poor for $Na,Ca,$ and $Ti.$ What do you suspect may be the cause and why?

You acquire the following mass spectrum from an unidentified contaminant in one of your extracts. You are tasked with identifying whether there are halogens in the compound based on the spectrum alone. Is this possible? If not, why not? If so$,$ what is your assessment?

Analytical Technician Homework Assignment