Pessaries, manufacture

For pessaries manufactured by granulation and compression if the licensee does not have a tablet section, a separate area of minimum thirty square meters and the following equipment is considered necessary ... 

The large-scale manufacture of suppositories and pessaries uses either the fusion method where the drug is dispersed in a molten base and the mixture poured into molds to solidify, or the cold compression methodJ In the latter process, the medicament and cold-grated base, usually theobroma oil or witepsol base, are intimately mixed and placed in a cylinder. The mass is extruded by means of a piston through small holes that connect with the mold. The cavities are filled by pressure with the mass which is prevented from escaping by movable end plates. The plates are removed and the suppositories ejected by further extrusion. The extrusion equipment is chilled to prevent melting of the components due to the heat generated by the friction of compression. 

The following equipment is recommend for manufacture of Pessaries and Suppositories ... 

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