Etc. Flashcards
For the peristaltic pump, how do you determine the appropriate pump/tubing size combination?
Use the pump/tube combination table in SOP535
What should operators monitor during peristaltic pump processing?
Tubing pressure
How often should the tubing be inspected for spallation or ruptured tubing?
About every 30 minutes
What is the cleaning solution employed for manual cleaning?
RBS 35 liquid concentrate
What is the concentration of the RBS cleaning solution?
2% i.e. 20 mL of RBS per 980 mL of WFI
What is the RBS soaking time?
30 min
What do you do with items after the 30 min mark?
Scrub all surfaces
How should parts be labeled once cleaned?
Parts should be labeled as ‘Clean’ and include an expiration date of 30 days from the date object was cleaned
Which cycle are we using to autoclave WFI hoses?
General
True/False: WFI hose can be left attached to WFI drop overnight
False
How to check WFI drop temperature?
On DeltaV
Steps for disinfecting and moving raw materials and small equipment into the GMP manufacturing facility?
- Place material on less clean side of MAL on a warehouse cart
- Wipe down with Spor-Klenz
- Let it sit for 10 min
- Personnel on clean side wipe it off with a lint-free wipe
- Wipe with 70% IPA wipe and place the material on a clean plant dedicated cart
What are three requirements for equipment to be suitable for use?
Equipment must be clean and within expiry. Equipment must be in current calibration. No alarms. Cannot be tagged “Out of Service”. Cannot be currently in use for another process
Name any three areas of focus prior to initiating a unit operation
Environment (area), equipment, material, & documentation
When would MAL 307 not be used to transport properly disinfected materials?
When MAL 307 is used for waste transport
What is the purpose of line clearance?
To inspect the manufacturing work area, to assess area and equipment suitability, and to verify materials and process specific documentation prior to initiating a unit operation
What are three requirements for materials that must be verified to be considered suitable for use?
All raw materials must be issued, identity verified, within expiry, and correctly labeled
What do you do if a line clearance requirement cannot be resolved?
Contact QA for guidance
Why can only pressure-rated hoses be used for the Integritest?
To prevent a pressure-safety incident
What is the minimum flush duration for a hydrophilic filter?
3 minutes
How long after powering on the Integritest should the unit be allowed to equilibrate to ambient pressure and temperature, if the unit was powered off for more than 3 hours?
No less than 45 minutes prior to use
What actions need to be taken if the filter fails after the first integrity test? What actions need to be taken if the filter fails after the second integrity tests? After the third integrity test?
If the filter fails after the first test, rewet the filter and test again.
If the filter fails after the second test, consult with the Subject Matter Expert (SME) on how to proceed forward for the third test.
If the filter fails after the third test, it is considered a failed filter test and QA and the manufacturing supervisor must be consulted on how to proceed
Why is it important to always shut down the unit within the Millipore Integritest 5 software?
Manually powering off can cause system errors
At what battery charge level is it necessary to charge the MasterMover machine?
Between 30 to 50% charge
What steps need to be taken when a red light is displayed on the BDI?
Report the fault code displayed to the manufacturing supervisor
Why can’t 70% IPA be used to clean the inside of the battery compartment?
No water or solvent can come into contact with the battery
