Environmental Monitoring Procedures

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Test your knowledge on environmental monitoring procedures!

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Karinee

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Environmental Monitoring Procedures


Environmental Monitoring ProceduresVersión en línea Test your knowledge on environmental monitoring procedures! por Karinee 1 When performing routine monitoring in a specific cleanroom, how do you find what MODA EM plan should be used? This path will also lead you to the form that should be used if MODA-FDC is not working. Choose one or more answers a Appendix A in USWV-30403 b Contact your supervisor or an experienced EM tech on your team c Call the QC EM hotline 2 If the sampling locations or map do not align with the cleanroom work instructions what actions should be taken? a Escalate to area and EM management b Invalidate the samples that don't align by "No Testing" them in MODA c Adjust the locations yourself d Ignore what doesn't align 3 Prior to the use of any plates what must be checked on the label? a The control number b The part number c The expiration date d The manufacturer 4 Which of the following is not one of the 5 types of test methods used during EM sampling? a Surface b Total Particulate c Personnel Exiting d Composite e Settle Plates f Active Air 5 Why is it important not to disinfect gloves right before sampling? a Gloves are inherently sterile and do not require disinfection before sampling. b Disinfected gloves are more prone to tearing during sampling. c It may give a false negative result on glove samples d Disinfection can strengthen the glove material, making it harder to detect contamination. 6 Where do operators exiting Grade A BSC get plated? a In the Grade C Pal-In (Personnel Airlock) b At the sash or boundary of the Grade A environment c Directly outside of the BSC in the Grade B environment d In Grade D 7 What is the maximum duration personnel are allowed in the Grade B cleanroom? a 2 hours b 4 hours c 6 hours d 8 hours 8 Which of the following does not have to be checked prior to use of Active Air & Total Particulate samplers? a Samplers have been charged b All sampler parts are available c Samplers are free from defects d Samplers have been tested by QC EM within the last month e Sampler date + time are correct f Samplers are within calibration 9 What are the MODA-FDC workflow steps that occur after printing labels? Listed in the correct order. a 1- Autogroup & Incubation, 2- Timestamp, 3- Results entry, 4- Ambient incubation b 1- Ambient incubation, 2- Results entry, 3- Timestamp, 4- Autogroup & Incubation c 1- Results entry, 2- Timestamp, 3- Autogroup & Incubation, 4- Ambient incubation d 1- Timestamp, 2- Ambient incubation, 3- Autogroup & Incubation, 4- Results entry 10 When is surface sampling performed during environmental monitoring? a After cleaning b Before processing begins c At the end of processing but prior to cleaning to avoid tracking dirt from dirty to clean surfaces d During the post-line cleaning 11 Surface sampling must be performed for all locations except for? Choose one or more answers a Any surface location that is tagged out of service such as equipment b Any surface location that you don't have enough media to sample c Any surface location from the EM map that is not in the room d Any surface location that you don't have time to sample due to end of shift 12 What must you do if the surface location such as an equipment surface is tagged out or is not in the room? Choose one or more answers a Sample must be scheduled in MODA-EM b Replace the surface location with any available surface nearby c Sample must be acquired in MODA-FDC and invalidated as a "no test" sample d A note must be made in MODA-FDC 13 What is the maximum duration a settle plate can remain open? a 2 hours b 4 hours c 6 hours d 8 hours 14 What is the purpose of purging the particle counter? a To reset the counter b To calibrate the device c To clean the sensors d To remove residual particles inside tubing 15 If you observe an increase in continuous particle counting in Grade A describe your actions. Choose one or more answers a Always perform a confirmatory sample b Have the operator immediately come out of the BSC until numbers return to normal c Close the containers and/or finalize the critical step to secure the final product d Always make a note in MODA-FDC 16 What is the difference between At Rest and In-Operation monitoring? a They are the same b At Rest is during cleaning; In-Operation is during maintenance c At Rest is with personnel; In-Operation is without personnel d At Rest is no personnel present; In-Operation is with personnel working 17 At the end of operations there are 4 steps (that are all listed below) involved in the order of sampling for the BSC. Which step happens 3rd? a BSC operator is plated out of the BSC b BSC operator closes settle plates c The 2 surface viable samples are performed in the BSC before BSC cleaning is performed d Continuous total particulate monitoring of the BSC continues until the last cycle is complete 18 This order of timestamps for the BSC is correct. T/F? 1- timestamp settle plate open time 2- timestamp settle plate end time 3- the last cycle of Grade A total particulates is completed 4- timestamp BSC surface samples Choose one or more answers a False b True 19 During MODA-FDC grouping what must be performed? a All samples must be discarded to prevent cross-contamination b Only equipment used for proccessing needs to be reviewed c TSA & rodac plates must be counted then grouped together in MODA then labels must be printed for the plastic bags & EM logbook in Grade D d Environmental conditions must be changed to match group criteria

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Environmental Monitoring ProceduresVersión en línea

por Karinee

When performing routine monitoring in a specific cleanroom, how do you find what MODA EM plan should be used? This path will also lead you to the form that should be used if MODA-FDC is not working.

If the sampling locations or map do not align with the cleanroom work instructions what actions should be taken?

Prior to the use of any plates what must be checked on the label?

Which of the following is not one of the 5 types of test methods used during EM sampling?

Why is it important not to disinfect gloves right before sampling?

Where do operators exiting Grade A BSC get plated?

What is the maximum duration personnel are allowed in the Grade B cleanroom?

Which of the following does not have to be checked prior to use of Active Air & Total Particulate samplers?

What are the MODA-FDC workflow steps that occur after printing labels? Listed in the correct order.

When is surface sampling performed during environmental monitoring?

Surface sampling must be performed for all locations except for?

What must you do if the surface location such as an equipment surface is tagged out or is not in the room?

What is the maximum duration a settle plate can remain open?

What is the purpose of purging the particle counter?

If you observe an increase in continuous particle counting in Grade A describe your actions.

What is the difference between At Rest and In-Operation monitoring?

At the end of operations there are 4 steps (that are all listed below) involved in the order of sampling for the BSC. Which step happens 3rd?

This order of timestamps for the BSC is correct. T/F? 1- timestamp settle plate open time 2- timestamp settle plate end time 3- the last cycle of Grade A total particulates is completed 4- timestamp BSC surface samples

During MODA-FDC grouping what must be performed?