QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 519

SOP No. QAS-032.00 Effective date: mm/dd/yyyy
Approved by:

51.7 Procedure

51.7.1 S olutionS

51.7.1.1 media to be used
Soybean casein digest (TSB) broth shall be used for normal media runs while thioglycolate (TGB)
broth should be used for detection of anaerobic organisms when using a filtered nitrogen purge to
ensure anaerobic conditions.
Growth promotion batch of media should be challenged before using the media.
Prepare the media according to manufacturing direction, adjust pH, and sterilized by using
0.2 µm sterile filtration technique.

51.7.1.2 manufacturing methods/Process simulation
The manufacturing methods/processes simulation include the following steps; refer to individual
manufacturing formula & method (MFM) for each media fill run.

Filling equipment preparation Freeze drying process (if required)

Media preparation Vials transport and loading of freeze dryer

Sterilization Vials incubation in FD chamber under vacuum

Sterile filtration
Washing of commodities Vials stoppering, unloading, and scaling

Depyrogenation
Media addition
Filling

The filling operation of nonlyophilized products should be completed within 12 h (two shifts) as
shown in Table 51.1.

51.7.1.3 verification of medium sterility
Perform sterility test for the bulk media after filtration while bio-burden count before filtration.

51.7.1.4 filling operations

1. The containers and closures should be cleaned and sterilized as per current SOPs.

2. The filling machine is operated at the predetermined and validated fill rate for the used
container size.

table 51.1
nonlyophilized Products
runs

filling 12 h intervals/break

Run I Shift 1/Day 1 Shift 2/Day 1 3-4

Run II Shift 1/Day 2 Shift 2/Day 2 3-4

Run III Shift 1/Day 3 Shift 2/Day 3 3-4