What is Validation of sterile drug filling
aseptic process?
Media fill in aseptic process validation: Bacteriological
media is taken for filling on the aseptic filling line, media is filled using
the pre sterilized primary containers and closures, and the finished product
pack is incubated at the temperature condition in the incubator as required for
the bacterial and fungal growth. Media fill is a method to validate aseptic
sterile drug filling equipment and area.
If at all there are any contaminants getting
added in the filling line due to man or faulty cleaning and sterilization
procedure, equipment, there will be a bacterial growth observed in the filled
media. That is considered a media fill fail.
And if there is no growth observed or the
results are well within the permitted limit then it is said that media fill is
passed.
Sterile dosage form filling:
Sterile dosage form filling equipment and area
are expected to, not to add any bacterial or microbial contamination into the
product during filling. To assure that the cleaning and sanitization
sterilization process adapted for filling equipment does not add any viable
contamination is a challenge, Media fill is an experiment to exhibit that the
filling line does not add to any microbial contamination.
Why does the media fill.?
This gives a clear picture of the sterile
filling line whether the filling line is completely sterile so that if the
product is filled by adapting the same filling line and procedure and same
operators will produce the sterile product without adding any contaminants into
the product and the product will remain sterile after filling.
Which Media is used for media fill?
Soyabean Casein digest media (SCDM) is used for
media fill; this media supports growth of almost all microorganisms including
fungus.
What is positive control in media fill?
It is required to exhibit that the
microbiological media used itself is capable of promoting the growth of the
bacterial and fungal cell. This is done by inoculating the standard known
microorganism into the filled container in the microbiology lab under LAF.
What is negative control in media fill?
It’s important to exhibit proof that the media
used for filling is sterile and that any growth obtained after media fill is
not due media, for this reason a sterilized media is incubated; this is called
negative control.
Which are important points during the media fill
run? Personnel requirement of
media fill.
When a person becomes qualified for an aseptic
filling process?
Rules for media fill in sterile dosage form
aseptic filling process validation:
1) Media filling should
actually be done as that of the actual batch of the product adapting the same
procedure, it should mimic the same operation as that of actual product
filling.
2) The Media fill should be
done at the actual filling spot on the equipment where it is done in routine.
3) All the operators must
participate in the media fill run.
At least once in a year
an operator should participate in a media fill run.
4) Media fill should be
done for three consecutive days in continuation.
5) Media fill should be
done as and when there is change in the equipment design or the new operator
taking over the activity. Procedure of sterilization is changed or addition of
a new product.
6) An operator,
supervisor is certified to be qualified for filling up on participating in a
successful media fill run for three consecutive days.
7) All the personnel
involved in sterile dosage form filling are required to participate in the
media fill run.
8) Before the media
fill, the media should be tested for growth promotion tests.
9) Media used in the
media fill should be from an approved vendor.
10) Any one
microorganism is used for growth promotion tests and positive control.
Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa.
Growth promotion test is done on media in
isolated manner, while positive control is more or less same but the media
sample inoculated challenged microorganisms are incubated along with the media
fill samples.
What is bacteriological and fungal, growth
promoting media?
Microbiological Nutrient media consist
of high protein containing items like beef extract, yeast extract, soybean
digest, casein digest, sodium chloride and water. These mediums promote the
growth of a single bacterium into a colony of bacteria, or fungi, which are
then visible to naked eyes as a colony.
Typical composition of a nutrient broth is as
follows:
Distilled water, 500 ml Beef extract 0.5 gm,
Yeast extract 1 gm, Peptone 2.5 gm Sodium Chloride 2.5 gm.
The difference between the nutrient broth and
nutrient agar is that nutrient agar contains Agar 7.5 gm per 500 ml in addition
to the all items of nutrient broth.
No comments:
Post a Comment