Sterile Pharmaceuticals Chapter 1

The term "sterile" in pharmaceutical preparations means:

• Free from pyrogens

• Free from particles

• Contains an acceptable number of microbes

• Free from viable microorganisms

The following product should be sterile EXCEPT:

• An eye drops

• An ear drops

• An injectable solution

• A peritoneal dialysis fluid

The following is a characteristic of sterile pharmaceutical preparations EXCEPT:

• Pyrogen-free

• Properly packaged

• Contains a limited number of visible foreign particles

• Physiologically compatible

A pyrogen is:

• A substance that reduces the drug's efficacy when present in a formulation

• A substance that causes an infection when introduced into the body

• A substance that causes fever when introduced into the body

• A substance that increases the drug's efficacy when present in a formulation

Pyrogens in pharmaceutical formulations are detected using:

• Mice Test

• Rabbit Test

• Chicken Test

• Human Test

The following routes of administration bypasses the body’s natural defenses.

• Oral

• Topical

• Rectal

• Intravenous

The following is an example of a parenteral preparation.

• Timolol eye drops

• Sterile water for irrigation

• Sodium chloride 0.9% injection

• Salbutamol nebulising solution

The following preparation should be sterile.

• Dry powder inhaler

• Nasal spray

• Nebulising solution

• Metered-dose inhaler

The following is the greatest source of contamination in aseptic areas.

• Raw materials

• Personnel

• Equipment

• Environment

The following control measure is most appropriate to reduce contamination from the environment.

• Proper gowning

• HEPA filtration

• Wearing sterile gloves

• Use of preservatives