SOP-0001-DV/SOP-0005-MFG
The Gowning Zone numbers where you wear burgundy and blue scrubs.
What are G-5 and G-6?
Contact time for Sporklenz.
What is 10 minutes?
Clean hold times for the UF/DF, SD Tanks.
(Bonus 100: The piece of equipment that has an indefinite clean hold time.)
What is 7 days and 14 days?
What is TNK-13?
Amount of PDH4s used for STAX.
What is 8?
Method used to help thaw the bottles.
What is gentle agitation?
The period of time a plant uniform (scrubs) is reuseable thorugh.
What is one calendar day?
Months where LPH is used.
(Bonus 100: if you can list when Vesphene is used)
What are odd months?
Hertz setting for CIP pump.
What is 49 hertz?
Level of operator that must approve the SD tanks for process use.
What is a supervisor?
Maximum amount of time the bottles can be in the thaw bath.
What is 120 minutes?
The HVAC Classification of the CEPAs.
What is ISO class 8?
The frequency of sanitization during partial shutdown.
What is once a week?
Amount of 0.5 NaOH dispositioned into TNK-13 for cleaning.
What is 34kgs?
Samples taken before product enters 104 for bottling.
What is E5A?
The piece of equipment that needs to be visually inspected before the start of thawing.
What is the affinity column?
The acronym "CEPA" stands for blank.
What is a Controlled Environmental Production Area?
Instance where safety shields can be used instead of goggles.
What is ceiling sanitization?
What is permeate?
Three parameters for successful solvent detergent hold.
What are time, temp, and homogeneity?
PPE that must be worn when draining the THAW heater.
What is a face shield?
(Bonus 100: Thermal Gloves)
Items that can can be transferred through G-3 as opposed to reiciving.
What are personal electronics, laptops, or small equipment and documentation?
SOP used for non-controlled support areas.
The pressure point and gauge required for the NWP.
(Bonus 100: The pressure point and gauge required for the air diffusion value.)
What is 5psi on the Retentate Gauge?
What is 7psi on the Feed Gauge?
A change in this parameter indicates the beginning of the UREA cycle.
(Bonus 100: Name the value the parameter needs to be under.)
What is pH?
What is 3?
Two things that must match before bottles are utilized.
What are serial ID tags?