Room Cleaning
What is the SOP # for Room Cleaning?
MFG-0004
What is the clean hold time for Pots
48 or 72
What is the set point for the thawing tubs?
95-100F
What is the elapse time calculation and limit for coolers getting into the freezer during cooler receiving?
open of first cooler to time in freezer (must be less than 75 min)
What does GDP stand for?
Good Documentation Practices
What are some important things to remember when performing room cleaning?
Face shield, 5x5 area, Cieling, Walls Floors, clean to dirty
How do you calculate elapse time During sampling?
the times from thaw to freezer
What samples are pulled when sampling?
Drug, Dilution, DNA, Adulteration DTOM, BC, BC Retention, Dil/AD Retention
How often does the freezer need to be monitored?
Each scheduled shift
Why is GDP important?
So Prolacta can minimize the risks of misinterpretations, errors in communication and ensuring great product quality.
What are the Solutions used in room cleaning
Process NPD, LPHse, Spor-klenz
What are the cycle options for the pot washer?
Cycle 1: 2.5L container
Cycle 2: SS Pots and Lids
Cycle 3: Rinse Cycle
Why is the latest dated milk bag important?
Need to make sure the milk is within the qualification period
When does QA need to come inspect a shipment?
signs of thawing, leakage, missing both zip ties, unusual odor, unusual color, milk received in atypical bags, improperly packaged, unexpected items
What is the GDP code for wrong date?
WD
You must perform weekly room cleaning every _____ days
1 calendar week
What do you need to check prior to starting the Pot Washer?
DI Line, Prime Pro-Klenz in needed, line must be submerged
Why is it important to change you PPE when sampling?
to prevent cross contamination
For cooler shipping process, the donor ID must match in what 3 places?
Tracking Label, Donor Shipment Page, MBTS
What is the GDP code for illegible entry?
IL
What happens if you miss a room cleaning?
OR
Why do we check the donor status when we are prepping MRs for sampling?
Donor status could have changed, RMA could have made a mistake, etc.
What must be done prior to opening a MR?
Line Clearance, Check Cleaning, Document MR#, Tubs if 1st MR, Don PPE, Prep Cart, Tag pots w/ Color
Why is CSR needed for certain shipments?
What color ink is required while working at Prolacta?
Blue or Black indelible ink