PHARMACEUTICAL PRODUCT MANUFACTURING - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 279

A common risk in the compression process is the improper setup of the metal
punches or dyes. If the equipment is not setup so that the metal punches are in
alignment, the metal parts will rub together, causing the metal to shear and emit
metal particles that contaminate the product.
11.2.3.2 Film Coating The tablets may be film coated. In this step, the tablets
are typically placed in a rotating drum, atomized with a coating solution, and air
dried. In most cases the coating contains an inactive ingredient that protects the
active ingredient inner core formed during the compression step. If the coating
is not applied evenly and/or in the correct amount, there could be a risk that the
dose is not properly delivered or that the exposure of the active ingredient to the
environment may adversely impact the product stability. In addition, the tablet
must be dried to ensure that the coating adheres to the core. If the tablets remain
wet at the exit of the film coating equipment, they could stick together removing
the coating when separated. Factors that can impact a proper film coating process
are as follows:
• incorrect solution applied;
• incorrect solution preparation where the solution is too thick or thin, pro-
hibiting even flow or appropriate flow rate;
• equipment malfunctions such as clogged spray nozzles; and
• incorrect operating parameters such as wrong rate and time of solution atom-
ization, drum rotation, or air drying temperature.
11.2.3.3 Branding The tablets may be imprinted with an identifier such as
the manufacturer's name. This identifier helps the patients to know that they are
receiving the correct drug. An ink solution is typically injected onto the tablets.
Similar risks are involved as those described for the film coating:
• incorrect ink solution preparation where the ink is too thick or thin and the
flow is not even or consistent;
• equipment malfunctions such as clogged ink jets; and
• incorrect operating parameters such as inadequate pressure to apply ink.
11.2.3.4 Packaging In this step, the product is filled into its final container,
which provides protection over its shelf life and provides the patient with infor-
mation for its safe use. Some of the common risks are as follows:
• wrong product, product mix;
• incorrect label, expiration date, or patient information provided;
• missing or overfilled drug product; and
• inadequate or compromised package integrity.