ABSTRACT
In the pharmaceutical industry, the term “packaging” has
many different definitions. Packaging can bring to mind
visions of employees gathered around a table labeling
clinical trial materials and placing them into corrugated
cases and sealing the cases with tape, or highly auto-
mated equipment filling parenteral solutions into sterile
containers in an aseptic environment. To simplify this
discussion the author has subdivided “packaging” into
five processes:
1. Filling
2. Sealing
3. Oxygen removal
4. Inspection
5. Secondary packaging
The most critical quality characteristic controlled by
the filling process is to manufacture well-controlled doses
of the product, which can be characterized by fill volu-
me/fill weight control and dose uniformity. The sealing
process will examine two of the processes that are most
commonly used in parenteral dosage forms: flame sealing
(ampules) and glass/elastomeric container closure
systems (vials and syringes).
