QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 516

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

• An action level exceeded, unless an assignable cause for the exceeded action level is
identified.
• Production lines have not been in operation for an extended period of time, for example,
more than 6 months.
• There has been signiicant changes such as:

a. Modification in equipment directly contacting bulk product or product container.

b. Modification in equipment/facilities, which can affect air quality.

c. Major changes in production personnel.

51.3.4 P roduct /c ontainer c onfiguration
Configuration representative of other filled products which bracketed all others with respect to size,
fill, container opening, line speed, manipulations, and so on or the product deemed to be the worst
case with respect to the opportunity for contamination, for example, a container which has the larg-
est opening and is conveyed at the slowest line speed.

51.3.4.1 selection of container
51.3.4.1.1 Vials Products
Currently the ABC Pharmaceutical Company uses four sizes of vials, that is, 10, 15, 20, and 30 mL
vials. To ensure the sterility during the aseptic processing, it was decided to simulate the media fill runs
on only 10 and 30 mL vial sizes since the 15 and 20 mL vial sizes will be bracketed in between 10 and
30 mL vial sizes. A measure of 10 mL vials with maximum speed, minimum volume and 30 mL vials
with minimum speed, maximum volume are taken as worst cases. The details are as follows:

size/description 10 ml 15 ml 20 ml 30 ml

Fill volume (mL) 8 10 10 15

Closure diameter (mm) 20 20 20 20

Line speed 80% 80% 70% 50%

160 vials/min 160 vials/min 140 vials/min 124 vials/min

In addition to 10 and 30 mL vials, media fill will also be carried out on 3 mL vial size using 90% or
180 vials/min line speed.

51.3.4.1.2 Ampoules
Currently the ABC Pharmaceutical Company is using three sizes of the ampoules, that is, 1, 2, and
3 mL ampoules for aseptically filled products. To ensure the sterility during the aseptic processing,
it is decided to simulate media fill runs only for 1 mL ampoule and 3 mL ampoule sizes, since the
2 mL ampoule size will be bracketed in between 1 mL and 3 mL ampoule sizes. Ampoules of 1 mL
will be run with maximum speed and minimum volume, whereas 3 mL ampoules with minimum
speed and maximum volume will be taken as worst cases. The details are as follows:

size/description 1 ml 2 ml 3 ml

Fill volume (mL) 1 2 3

Line speed 100% 100% 92%

200 Amp./min 200 Amp./min 184 Amp./min