F is for Fiiltrsation
Scintillating Sanitization
All About That Time Frame
API or DIE
Deviation 101
100

These receiving tanks are interchangeable.

What are tanks 74 and 75 (Remdesivir)?
100

This post clean consists of 10 internal rinses!

What is AmBisome post clean?

100

This pre-line has to be disconnected by Formulation NMT 8 hours after the start of the fill.

What is Media?

100

Once this API begins dilution it is NMT 48 hours to LYO slot door close.

What is Erbitux API (bonus points: Cetuximab)?

100

These tanks can't be moved with their bottom drain valves open or risk breaking their impeller.

What are glass tanks? (Tanks 85 and 86)

200

This line two product's sterile filtration occurs in the Formulation room.

What is Definity?

200

This tank records its internal sanitization in seconds.

What is Tank 81 (Definity)?

200

What process once lowered to a pH of 2.0 (1.9-2.1) it is NMT 8 hours until pH is adjusted to 3.5 (3.4-3.6). 

What is Remdesivir?

200

Thaw baths are used for this API's pooling process.

What is Rilonacept API?

200

This tool can ONLY be sanitized with NMT 90 C WFI.

What are the DO meter probes?

300

Bioburden samples are taken DURING this product's sterile filtration.

What is AmBisome filtration?

300

This post clean requires NLT 4 minute for its internal rinses.

What is ACAM post clean?

300

Making of this solution is an alternate to initial WFI for Start of Formulation.

What is Polysorbate 80 for OPV?

300

This API can't be out of -20 C storage for more than 72 hours cumulative.

What is Bulvirtide API?

300

This disposable mix bag can NOT be inflated during setup.

What are LevTech bags?

400

The receiving weight for this tank is the negative weight of the compounding tank.

What is Tank 11 (OPV)? (There are no load cells on tank 11)

400

This tank's sample port receives a NLT 2 minutes rinse during post clean. 

What is Tank 47 (Sestamibi)?

400

'NMT 14 minutes' and 'NLT 2, but NMT 3' are examples of the NaCMC addition time frames for what equipment?

What is the Powder Disperser?

400

This API uses QA33's results tab (NOT usage decision) to find its AQC data.

What is Choletec API (bonus points: Mebrofenin)?

400

This product filter's integrity used assessed with a forward flow test.

What is the OPV filtration skid?

500

This receiving tank requires a NLT 60 minutes nitrogen purge before it can be used.

What is Tank 25 (Choletec)?

500

This tank's glass sparge tube is sanitized by inserting a WFI wand directly into its inlet.

What is Tank 24 (Choletec)?

500

These pre-filtration samples have to arrive at the CRSS room NMT 60 minutes after they're taken.

What are Cardiolite and/or Neurolite samples?

500

This process' API thawing process for this API takes NLT 90 hours at 2-8 C storage and can be at RT for NMT 4 hours prior filtration.

What is DX88?

500

Initial WFI for this product is 65 - 85 C.

What is MDRV or Sulfur Colloid?

M
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