If I have sterile products which are clear liquids and homogeneous solution, can I use 0.2micron filter in series for filtration process.(No pre filter 0.45micron).??
The 2nd housing filter will act as my final filter (main filter) and 1st housing filter will be as a supportive filter…
Filter integrity will be checked basically for main filter…
If there is no viscous product or no problem in filtration rate u can use 0.2 micron cartridge filter in series.
in sterile area where HEPA is used n where ULPA is used?
in manufacturing of parenteral product, HEPA filter is sufficient to control air contamination.
For area sterilization whats are the basic steps?
like whicg ype of detergents are used for eashing floor n walls etc,for equipment washing?
Percentage of IpA used for mooping?
Thanks in advance for precious time
U can use following disinfectant for aseptic area.
1.combatan DS 1%
4.D 125 1.5%
Rotate the disinfectant on weekly basis.
Teepol can be used for equipment washing.
Mop the wall, ceiling with schedule disinfectant on weekly basis.
Mop the floor with schedule disinfectant on daily basis.
Clean the filling machine with wfi and then disinfect with 70%IPA.
Fumigation is banned now so fogging can be done with 0.5 % minncare or 20% virosil.
after fooging area should remain closed for over night?or what is the time period after which we can start manufacturing?
In case of 24 hour production , you should give at least 4 hour hold time after fogging.
in case of thermolabile sterile drug terminal sterlization is not suitable then we just use membrane filteration?pore size of membrane filter?
We can use cartridge filter or membrane filter and pore size should be 0.22 micron.
washing of ampules n vials in C class?
Mfg in C class?
Filling in A under LFH
Chang room of sterile area class?
Yes all is right.
First change room- class D
2nd change room-class C
3rd change room- class B
Aseptic corridor- class B
Exit change room-I - class B
washed vials n ampules r dried at which temp?
for wshing of ampules or vials RO water is used or WFI is used
- Temperature 310 to 340 degree centigrade
2.WFI is used for vial/ampoule washing.
uniform n gowning etc of sterile area are autoclaved?