Documente Academic
Documente Profesional
Documente Cultură
TESTING
By
PresenterMedia.com
In pharmaceutical manufacture, the sterility of a parenteral product lot is checked by
test 10 to 20 units of product per lot. The number of units tested may be doubled
5. the good manufacturing practice requirements of the regulatory agency for the
particular product.
SAMPLING REQUIREMENTS
For example,
Jika ukuran batch lebih besar dari 500 artikel, minimum 20 unit artikel yang di
sampling
Jika ukuran batch akhir antara 100 dan 500 artikel, maka tidak kurang dari 10 artikel
Untuk produk LVP (volume 100 mL/ wadah), paling sedikit 2% dari batch atau 10
Persyaratan sampling untuk Pengujian Sterilitas yang di spesifikasikan dlm USP dan
mm.
TSB has a slightly higher pH (7.3 0.2) than FTM (7.1 0.2).
TSB replaced Sabouraud medium in the 19th edition of the USP (1970) because TSB was
It possesses a higher pH and thus was considered a better nutrient for fungal contaminants.
TSB promotes growth of fungi and bacteria and is also considered a better medium for than
days.
TIME AND TEMPERATURE OF INCUBATION
TIME AND TEMPERATURE OF INCUBATION
TIME AND TEMPERATURE OF INCUBATION
STERILITY TESTING
The USP and EP sterility tests specify two basic methods for performing
sterility tests :
1. the direct transfer (DT) or direct inoculation method and,
2. the MF (Membrane Filtration) method, with a statement that the latter,
when feasible, is the method of choice.
. In fact, in some cases, membrane filtration may be the only possible choice.
STERILITY TESTING
tube containing the required volume of FTM and the other half
culture medium.
1.
DIRECT The sample volume must be a sufficient representation of the entire
microbial growth.
STERILITY TESTING
1.
DIRECT
TRANSFE
R
STERILITY TESTING
The MF sterility test became official in the 18th edition of the
USP in 1970.
LVPs.
Five basic steps are involved in the use of the MF sterility test method:
1. The filter unit must be properly assembled and sterilized prior to use.
ml) of FTM, and the other membrane half is placed in an equal volume
of TSB
STERILITY TESTING
2.
MEMBRANE
FILTER
STERILITY TESTING
ADVANTAGES OF MF
1. Greater sensitivity
ADVANTAGES OF MF
MEMBRANE test results since MF requires only 7 days incubation (for most terminally
FILTER
sterilized products).
DISADVANTAGES OF MF
An accent, click
An accent, click to
to edit
edit the
the An accent, click
An accent, click to
to edit
edit the
the An accent, click
An accent, click to
to edit
edit the
the
text inside.
text inside. text inside.
text inside. text inside.
text inside.
Comparison Page Layout
A second line of text could go here
COMPARISON OF ITEM ONE COMPARISON OF ITEM TWO
This is a place holder for item one.
Item one can be text, a picture,
graph, table, etc.
Here is level two
Here is level three
Level 4 This is a place holder for item one.
Level 4, you may add more text or Item one can be text, a picture,
delete this text. graph, table, etc.
Here is level two
Here is level three
A Two Column Page Layout
A Second line of text can go here.
Here is the description of the table. You United States 1254 1254 125 1254
may change or delete this text as you 4
wish.
Europe and 324 324 324 324
Asia
This chart is compatible with PowerPoint Australia 32 32 32 32
97 to 2007.
South America 2 2 2 2
Chart Title
Here is the description of the chart. You
may change or delete this text as you 5
wish.
4.5
4
This chart utilizes features only 3.5
available with 2007. 3
2.5 Series 1
Here is a placeholder for more text and 2 Series 2
description of the chart. Changing this 1.5
text will not interfere with the Series 3
1
formatting of this template.
0.5
0
Pie Graph Page Layout
PowerPoint 2007 Enhanced Version
Chart Title
Here is the description of the chart. You 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
may change or delete this text as you
wish.
23%
Here is a placeholder for more text and
description of the chart. Changing this 9% 10%
text will not interfere with the
formatting of this template.
Smart Art Page Layout
PowerPoint 2007 Enhanced Version