Pharmaceutical Manufacturing Handbook: Production and

TABLE 5
Chapter
U.S. Pharmacopeia General Tests and Assays
Topic
〈 1 〉 Injections
〈 51 〉 Antimicrobial preservatives — effectiveness
〈 61 〉 Microbial limit tests
〈 71 〉 Sterility tests
〈 87 〉 Biological reactivity tests, in vitro
〈 88 〉 Biological reactivity tests, in vivo
〈 161 〉 Transfusion and infusion assemblies
〈 381 〉 Elastomeric closures for injections, biological test procedures, physicochemical
test procedures
〈 601 〉 Aerosols
〈 661 〉 Containers: light transmission; chemical resistance — glass containers; biological
tests — plastics and other polymers; physicochemical tests — plastics;
containers for ophthalmics — plastics; polyethylene containers; polyethylene
terephthalate bottles and polyethylene; terephthalate G bottles; single - unit
containers and unit - dose containers for nonsterile; solid and liquid dosage
forms; customized patient medication packages
〈 671 〉 Containers — permeation: multiple - unit containers for capsules and tablets;
single - unit containers and unit - dose containers for capsules and tablets
〈 691 〉 Cotton (or the monograph for purifi ed rayon USP)
〈 771 〉 Ophthalmic ointments
〈 1041 〉 Biologics
〈 1151 〉 Pharmaceutical dosage forms
Source : From ref. 10 .
QUALITY CONTROL OF PACKAGING MATERIAL 177
variety of forms, from impact through vibration in transit and compression forces
on stacking.
The demands for mechanical protection will vary with product type: Glass
ampules will require greater protection than plastic eye drop bottles, for example.
Other protection is required from environmental factors such as moisture, temperature
changes, light, gases, and biological agents such as microorganisms and, importantly,
humans.
The global market for medicinal products requires that the products are stable
over a wide range of temperatures ranging from subzero in the polar region, 15 ° C
in temperate zones, up to 32 ° C in the tropics. Along with this temperature variation,
relative humidity can vary from below 50% to up to 90%, a feature that the packaging
should be able to resist if necessary. The majority of packaging materials (including
plastics) are to some degree permeable to moisture and the type of closure
employed, such as screw fi ttings, may also permit ingress of moisture. The susceptibility
of the product to moisture and its hygroscopicity will have to be considered
and may require packaging with a desiccant or the use of specialized strip packs
using low - permeability materials such as foil.
Temperature fl uctuations can lead to condensation of moisture on the product
and, with liquids, formation of a condensate layer on top of the product. This latter
problem is well known and can lead to microbiological spoilage as the condensate
is preservative free.