Validating cleaning procedures in biopharmaceutical manufacturing facilities

This may be especially important for operations with topical products, suspensions and bulk drug or where the drying of residues will directly affect the efficiency of a cleaning procedure.9.1.3 The practice of resampling should not be used before or during cleaning and operations and is acceptable only in rare cases.

Constant retesting and resampling can show that the cleaning process is not validated because these retests actually document the presence of unacceptable residue and contaminants resulting from an ineffective cleaning process.(referred to as a “swab”) and rubbing it methodically across a surface. The protocol should identify the sampling locations.

anovulent steroids, potent steroids and cytotoxics) should be undetectable by the best available analytical methods.

The manner in which limits are established should be carefully considered.

In establishing residual limits it may not be adequate to focus only on the principal reactant, because other chemical variations may be more difficult to remove.11.11 Certain allergenic ingredients (e.g.

Other methods may include (alone or in combination) measurement of total organic carbon (TOC), p H, or conductivity; ultraviolet (UV) spectroscopy; and enzyme-linked immunosorbent assay (ELISA).11.1 The acceptance criteria established for contaminant levels in the sample should be practical, achievable and verifi able.

The rationale for the residue limits established should be logical, and based on the knowledge of the materials involved.11.2 Each situation should be assessed individually.

Leave a Reply