ALCOA
The two "A" words that begin and end ALCOA.
What are 'attributable" and "accurate"?
The individual performing this function is physically present at the time the step is being performed to ensure that the operation or calculation was conducted as required per SOP and the batch record.
The frequency with which sinks and drains must be flushed with Spor-Klenz.
What is "weekly"?
Non-disposable parts that have been used must be cleaned, rinsed and blown dry within this time frame.
What is "24 hours"?
Steam sterilized parts may be kept and utilized in the Aseptic Core for up to ____.
What are "30 days"?
Requires that records are readable and retained in a permanent format throughout the data lifecycle.
What is "legible"?
Recording or signing a prior date is called __________ and is strictly prohibited.
What is "backdating"?
The amount of time that must elapse between completing of disinfection and the start of another activity.
What is "dwell time"?
Parts must soak in the WFI/Synperonic detergent solution for a minimum of ___ and then be rinsed with safe temperature WFI for at least___.
What are "5 minutes" and "10 seconds"?
Once an item has been wiped down with 70/30 IPA and sprayed with Spor-Klenz, it must sit in the inner air lock for___ prior to passing through into the Aseptic Core.
What are "15 minutes"?
This medium can be a database, an approved protocol, or a dedicated notebook.
What is "original"?
When performing calculations, the rounding rule is to round up at __ and above and to round down at __ and below.
What are "5" and "4"?
The amount of time a bucket of prepared Vesphene is good to use for cleaning.
What is "24 hours"?
When sterilizing work orders, forms, and/or other paperwork, no more than ___ are to be placed in a single Tyvek bag.
What are "50 pages"?
During Line Clearance qualification, any one candidate may fail a maximum of ___ tests, after which they will not be considered suitable to qualify on that particular equipment.
What are "2 test failures"?
The two "C" words that begin ALCOA+.
What are "consistent" and "complete"?
Regulations that are enforced by the U.S. Food and Drug Administration to assure the proper design, monitoring, and control of manufacturing processes and facilities.
What are Current Good Manufacturing Practices(cGMP)?
The length of time a sterilized bucket can remain in the Aseptic Core, if bucket liners are utilized when cleaning, before it must be re-sterilized?
What are "30 days"?
All cleaned/washed/prepped parts must be either sterilized or used within___.
What are "24 hours"?
The routine performance and documenting of Daily, Weekly, and Monthly cleanings in PDS is the responsibility of ____.
Who is "everyone"?
A secure system time/date stamps that cannot be altered by personnel is an example of this.
What is "contemporaneous"?
Use of a computerized system in which there is a combination of original electronic and paper records that comprise the total record set.
What is the "hybrid approach"?
The color scheme for the Triple Bucket System for cleaning is set up from the inner most bucket (under the wringer) outward in this manner.
What is "red, then blue, then white"?
When preparing cleaning solution for parts prep, the proper concentration to mix is ___ of Synperonic to ___ of WFI.
What is ".2 mls" to "1 liter"?
When performing manual inspection operations, ergonomic breaks are to be taken at regular intervals not to exceed ___ of continual inspection.
What is "60 minutes"?