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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
This is the first packaging envelope which is in touch with the dosage form or equipment	Primary Packaging (i.e.bottle, cap, cap liner, label etc.).
The main functions of the primary package	1 to contain and to restrict any chemical, climatic or biological or occasionally mechanical hazards that may cause or lead to product deterioration. 2 Packaging must also function as a means of drug administrations.
This is consecutive covering or package which stores pharmaceuticals packages in it for their grouping.	Secondary Packaging E.g. Cartons, boxes, etc.
Function of Secondary Packaging	mainly provides the additional physical protection necessary to endure the safe warehousing and for refill packaging.
This is to provide bulk handling and shipping of pharmaceuticals from one place to another.	Tertiary packaging: E.g. Containers, barrels
This packaging guarantees safer medication by reducing medication errors; it is also more practical for the patient. Very useful in improving compliance with treatment and for less stable products.	Unit-dose packaging.
is intended to contain a drug substance or drug product with which it is, or may be in direct contact.	Container
QUALITIES OF GOOD CONTAINER:	1 Must be neutral towards the material which it store 2 Must not interact physically or chemically with the substance. 4 Must help maintain the stability of product against the environmental factors 5 Its materials can withstand wear and tear during normal handling. 6 Must withstand changes in pressure and temperature. 7 Must be non-toxic.
TYPES OF CONTAINERS	1 Well – closed containers 2 Single dose containers 3 Multi dose containers 4 Light-resistant containers 5 Tight container 6 Hermetic container 7 Aerosol containers
“protects the contents from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage, and distribution.”	Well – closed containers
used to supply only one of medicament and hold generally parenteral products.	Single dose containers E.g. ampoules and vials
allow the withdrawal of dose at various intervals without changing the strength, quality or purity of remaining portion	Multi dose containers E.g. vials
protect the medicaments which are photo-sensitive	Light-resistant containers:
“protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article; and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution and is capable of tight reclosure.”	Tight container-
“is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution.”	Hermetic container
used to hold aerosol products; have adequate mechanical strength in order to bear the pressure of aerosol packing.	Aerosol containers