Page 44 - Pharmaceutics IV (02-06-01305)

Pharmaceutical requirements

Clarity (for solutions)

Precautions & measures

• Manufacturing environment: clean surroundings, the use of
laminar-flow hoods, and proper non-shedding garments.

• Both container and closure must be thoroughly clean, sterile, and
non-shedding.

• The containers are carefully selected to be chemically resistant to
the solution and of the highest available quality to minimize the
chances of container components leaching into the solution.

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Pharmaceutical requirements

Clarity (for solutions)

Precautions & measures

• During manufacture, the parenteral solution is usually filtered just
before it goes into the container.

• Parenteral solutions are carefully inspected for the presence of any
foreign particles, such as glass, fibers, precipitates, and any floating
material. Any parenteral product samples found containing particulate
matter are discarded.

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Salma E. EL-Habashy