C) FORMULATION OF STERILE PRODUCT

C) FORMULATION OF STERILE PRODUCT

The product formulation is sometimes, just compounding of the ingredients. In other situations, the parenteral products are formulated as emulsions, suspensions, cream and ointments. All the process are undertaken in strict aseptic conditions.

Compounding of ingredients

The ingredients should be compounded under clean environmental conditions. A sterile condition is usually not required since it may not be possible or feasible to sterilize some of the ingredients or equipment, e.g., large tanks. Whenever possible, however, the equipments and the ingredients should be sterile to reduce the microbial load.

The compounding process should meet the rigid standards accepted in pharmaceutical procedures, regardless of the batch size, recognizing that small multiple errors may be additive. In large batches particular attention must be given to achieving and maintaining homogeneity of solution, suspensions and mixtures, maintaining a given temperature and accelerating cooling. The order of mixing ingredients may become highly significant, for example, owing to the physical problem of disturbing a pH adjusting ingredient throughout a large tank of liquid. Compounding problems for large batches of product often are different from those of the small batches.