Finished pharmaceuticals exist in a broad range of dosage forms, which include solid, semisolid, liquid, aerosols, and parenteral formulations. Often a large number of product types of several different strengths are manufactured in one facility. This necessitates the use of special precautions to prevent product-to-product carryover. One of the strategies designed to prevent cross-contamination is cleaning. The number of cleaning procedures, assays, and equipment types are often overwhelming. Using nondedicated equipment is a common practice among pharmaceutical industries. This creates further obstacles to meeting the objective of cleaning, and thus establishment of a cleaning validation program applicable to all products becomes a great challenge.
In biopharmaceuticals, the presence of a large number of contaminants such as cellular remains, media constituents, waste products of cellular metabolism, and buffer salts generated during manufacture are factors that cause extensive problems in cleaning. Identification of the residues is often difficult because they may vary from batch to batch. For example, the presence of a large variety of proteinaceous materials in the residue makes the differentiation of contaminants from one another a challenge. In the case of mammalian cell cultures, because of the nature of the source material, microbial contamination is of great concern. Multiproduct facilities further give rise to concerns for regulatory agencies.
The contaminants, which need to be cleaned from a bulk chemicals manufacture process, include precursor molecules, by-products, intermediates, and other forms of impurities. Manufacture processes of bulk chemicals are typically biochemical or chemical syntheses carried out on a large scale. These bulk chemicals are later used as active ingredients in a finished dosage form pharmaceutical. The bulk chemical manufacturing process is usually enclosed in large tanks and includes the direct transfer of materials from tank to tank after each particular reaction or process. In most cases, the involvement of closed systems is due to the use of strong reagents and chemicals. This gives rise to the need of either automated or semiautomated clean-in-place (CIP) technologies. Problems in the cleaning procedure validation often arise from the lack of direct sampling from many areas of the closed systems.
Keeping in view the struggle that pharmaceutical and biotechnology industries have in dealing with cleaning validation, an approach that establishes a comprehensive cleaning validation is required.
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