Dear All,
As per PDA 22- process simulation
Clean container of identical configuration may be substituted for opaque or Amber container to aid in detection of container…!!
How this can be done, by requesting manufacturer to provide the container as required or what?!!
As generally pharmaceutical have for:
Eye drops:white LDPE plastic bottles and caps.
Cream tubes: white propylene tube…
Ointment: Aluminum tubes…
Thanks…
1. Semi-Solid Products (e.g. sterile ointments) simulation test
For this simulation test the liquid growth medium is thickened to the
appropriate viscosity, used as in the routine production procedure. Suitable
thickening agents are agar and carboxymethyl cellulose. Other agents would
need to be validated with regard to lack of their bacteriostatic and fungistatic
properties. Metal and plastic ointment tubes prevent the examination of the
medium in-situ. Usually the whole content of the tube should be examined
and this is usually achieved by squeezing the contents into a plate (petri
dish), and after whirling it is examined for turbidity and fungal colonies under
defined light conditions or by performing a sterility test. If properly validated,
an alternative method for detection of contamination of semi-solid products
could be the use of media which changes colour in the presence of
contamination.
2.sterile product in plastic container
clear plastic containers are frequently used for process simulation
trials, the plastic is usually slightly opaque and thus hinders identification of
contaminated units that show only a slight haze. In such case examination
under natural or room lighting would not suffice. Where opaque containers
are used for process simulation trials the whole contents should be removed
for examination.
Dear Mr. Manoj,
As per your text and guideline reference, i have reformulated my formula from:
Current:
TSB+Liquid paraffin+white soft paraffin
Refomulated as:
TSB+ Carmellose sodium+tween+glycerol+WFI
But is this ok?? If you see the composition is somewhat look like aqueous not ointment formulation…
Thanks
Dear Mr. Manoj,
is there is any study need to be conducted for the qualification of the examiner/QC microbiologist
for examining the turbidity and fungal colonies under defined light conditions"
How certification shall be done for microbiologist any challenge test protocol need to design?.
Thanks