Proper Mixing of Bulk Solutions (09-02-00-030-WI)
Proper Mixing of Bulk Solutions (09-02-00-030-WI)
Filling Room Procedures (09-12-083-SOP)
Filling Room Procedures (09-12-083-SOP)
Filling Room Procedures (09-12-083-SOP)
Filling Room Procedures (09-12-083-SOP)
Filling Room Procedures (09-12-083-SOP)
100
Keep in-process bulk solutions "______" whenever possible.
Covered
100
Is the impeller height adjusted before or after starting bulk.
Before (ONLY!)
100
Do not touch _____ or _____ with gloves. If inadvertently touched, gloves must be changed immediately.
Skin or Hair
100
If exiting the fill room during a fill, notify ______ before leaving.
Lead person
100
If using a tank liner, what must be done after filling?
Inspect for leaks. If there is a breach, immediately notify Supervisor.
100
True/False: These pumps are equivalent
Watson Marlow 505 and 520
Watson Marlow 605 and 620
False
100
If a sinker is not used, what must be done to the filling tubing?
Cut a v-shape at the end to avoid suction on the side of the barrel.
200
This term is used in the context of "mix the solution until completely "__________" when mixing two liquid solutions into one.
Homogeneous
200
Once installed, place the impeller in the _______ position of the bulk tank prior to turning on mixer to avoid contact with tank liner
Middle
200
Do not transport _______ in bulk tanks.
Impellers
200
During filling, avoid reaching over ________ ________ vials or bottles when possible.
Unfilled open
200
What form must be completed for inspection of the tank liner?
Name form name or number
Post-Use Tank Liner Inspection Form, OPS-2189-FORM
200
Torque specifications are to tenths of _______ (hint: unit of measurement)
in-lbs
200
Direction to weigh 30 containers, 30 caps, and 1 label to determine an average tare weight needs to be performed when?
During an out of specification fill weight check result
300
Mixing or Stirring: When either of these terms are used, it requires the technician to mix or stir the solution at a speed that will cause a vortex of approximately "_____" of the depth of the solution
1/3
300
What are two materials used to seal slotted slits on bulk container, ensuring the product does not become contaminated.
Tape
Parafilm
300
Name two ways discrepancies between the machine counter and the actual bottle count can occur?
In process scrap
Machine recalibrations
Discrepancies between the fill checks taken by the machine count and the actual bottle may be explained in the batch record.
300
When handling bottles, vials or caps, DO NOT what?
Touch the inside (at all!!!!!!!!)
Explain why.....
300
Once a pressure alarm condition has been corrected, filling may resume after waiting ________ (amount of time) to allow for adequate air exchanges. Note the time filling was resumed on the MI.
10 minutes
300
An element/tubing assembly listed in a document BOM may be replaced with a _______ ________ (two words) without affecting filling parameters. Record on an SLI.
Smaller bore
300
When should refrigerated labeled reagents from an in-process, multi-day process be moved to the final storage condition?
At end of each day. This includes QC samples and partial totes.
400
When a mfg. document document directs a technician to mix or stir a solution vigorously or rapidly, it requires that a vortex of the solution be created reaches between _______ (Hint: It's a fraction) of the depth of the solution to the stir bar or bottom of the bulking container.
3/4
400
When using tank liners, do not allow impeller to come in contact with tank liners during ________, ________ and _______ of bulk solutions.
Installation, Removal and Mixing
400
If an empty bottle, vial or cap falls on the floor, it must be rejected. Do not ______ ________ the item until after the fill is complete or at the end of the day.
If it cannot be avoided, what must be don immediately after?
Pick up
Don a new pair of gloves before resuming mfg activities
400
When retrieving a bulk for a fill process, both the Operator and Checker must do what?
Audibly verify the P/N, L/N and Description of the bulk container against the DHR of the fill.
400
If a pressure alarm sounds during a filling operation, what must be done (name 4)?
1) Discontinue process ASAP without jeopardizing quality of product.
2) Ensure bulk container of product is covered.
3) Notify Mfg. ENG and FAC
4) Note the filling time was discontinued on the MI
400
If determined necessary, the fill tubing, element, sinker or nozzle may be replaced after initial setup.
What must be done if so?
Flush with water, pump prime, initial pump CAL and document on an SLI
400
If the bulk to be filled is from the previous fill, what may be re-used for the new work order AND what is not required to be repeated?
Fill element/tubing (same or smaller bore ONLY than listed in the new BOM)
Do not rinse re-used tubing
500
(1) For solutions of less than or equal to 50 liters, what can be used for mixing?
(2) For solutions greater than 50 liters what can be used for mixing?
Stir bar with stir plate or Overhead mixer
Overhead mixer
500
It is often stated in mfg. documents to "mix the solution until completely "__________" or to "mix the solution until all solids are "_________" . (same term for both)
These statements require that the solution be mixed until there are no chemical solids virtually present in the bulk. It is important for the technician to inspect the solution to confirm that there are no chemical solids still virtually present.
Dissolved
500
If a pressure alarm cannot be corrected and if the bulk Exp Date is such that the bulk cannot be stored, filling may resume at the direction of the Mfg. Manager.
What must be done with product if filling is resumed during a pressure alarm?
Segregate and identify product filled during alarm from product filled prior to the alarm.
500
For a yellow flashing light without an audible alarm, check all ______ fill room doors to ensure that they are properly closed.
For a red flashing light without an audible alarm, check all ______ fill room doors to ensure that they are properly closed.
An audible alarm with either or both lights flashing indicates a _________
Outer
Inner
DPM alarm
500
Operators should watch for visible defects to exterior of packaging of materials and/or labeled reagent containers. The following visible defects may include, but not limited to (Name 4)
500
Whenever there is a gap in the label roll due to a splice or missing label, a bottle may not be labeled and another bottle may be double labeled. If a bottle is missing a label, what must be done?
Check the three (3) bottles labeled before and (3) bottles after the bottle for a double label.
500
Weigh an empty container, this is the ______ (1) weight.
Weigh the same container filled, this is the _____ (2) weight.
Subtract the _____ (1) weight from the ______ (2) weight and record the resulting ______ weight.
Tare
Gross
Net