Selection of sterilizing filter

Sterilizing and filtering is a very important sterilizing method in pharmaceutical production. For non-final sterilization injection,
it is even the only means to remove microorganisms from the product. For drug manufacturers, how to select sterilizing filter should be considered first.

The selection principle of sterilizing filter

Filter selection should be based on the following principles, and the well has been validated accordingly:

(1) There can be no adsorption between the filter material and the filtered components, and the filter material can not release substances in the filtered components.

There should be no fiber stripping, that is, there should be good compatibility between the two.

(2) The integrity of the filter can be accurately detected, such as the use of bubble point, unidirectional flow test, etc.

(3) The filter material of the selected sterilizing filter can withstand the steam sterilization of 121"C, and the microbial retention test was qualified

The selection of suitable sterilizing filters in the production process is usually carried out through a series of diaphragm small-scale test, through the pilot scale test of the capsule filter,

To determine the best filter type for the production process,

In order to improve the load of the terminal filter and reduce the cost, the filter combination is often optimized in biopharmaceutical, and the protective layer filter and surface filter are added before the membrane filtration.

Because the titanium rod can play a role in clarifying and filtering, its cost is low, it is often selected as the deep filter with large filtration capacity, the aperture can be selected 10μm. 5μm or 3μm, the cost of the surface filter is low,

Used for pre-filtration before membrane filtration, usually made of polyethersulfone or polypropylene, the pore diameter can be chosen as 0.6μm. 0.45μm or 0.2μm. Membrane filters at the ends are more expensive,

A membrane filter with the maximum filtration rejection rate is usually used to achieve the final filtration effect. It is usually made of polyethersulfone material with the hole diameter of 0.2μm or 0.1μm.