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Packaging > Packaging > Flashcards

Packaging Flashcards

1
Q

Container:

A

Is that which holds the article and is or may be in direct contact with the article

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2
Q

The immediate container:

A

Is that which is in DIRECT contact with the article at all times. The closure is part of the container

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3
Q

The container should be…….prior to fillin

A

Clean

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4
Q

Tamper Resistant Packaging

A

The container or individual carton of a sterile article intended for ophthalmic or otic use shall be so sealed to ensure that the contents cannot be used without obvious destruction of the seal.

Over the counter articles must also follow this requirement

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5
Q

Light Resistant

A

Protects the contents from the effects of light by virtue of the specific properties of the material of which it is composed, including any coated applied to it. Meets USP requirements.

A clear or colorless or a translucent container may be made light resistance by means of an opaque covering.

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6
Q

Well-Closed

A

Protects the contents from extraneous SOLIDS and from loss of the drug under the ordinary or customary conditions of handling, shipment, storage, and distribution.

Used for solid dosage forms not prone to oxidation or hydrolysis.

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7
Q

Tight

A

Protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article, and from efflorescence (loss of water of hydration in hydrates), deliquescence (absorption of water vapor), or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is capable of tight re-closure.

A tight container may be replaced by a hermetic container for a single dose.

Liquid preparations and solid dosage forms prone to hydrolysis or oxidation.

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8
Q

Hermetic

A

Impervious to air or any other as under the ordinary or customary conditions of handling, shipment, storage, and distribution.

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9
Q

Single-Unit

A

Designed to hold a quantity of drug product intended for administration as a single dose or a single finished device intended for use promptly after the container is opened.

Each single-unit container shall be labeled to indicate the identity, quantity and or/strength, name of the manufacturer, lot number, and expiration date of the article.

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10
Q

Single-Dose

A

A single-unit container for articles intended for parenteral administration.

No antimicrobial preservation required

Maximum Volume: 1L

Preparations intended for intraspinal, intracisternal, or peridural administration

Single Dose, No preservatives

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11
Q

Unit-Dose

A

A single-unit container for articles intended for administration by other than the parenteral route as a single dose, direct from the container.

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12
Q

Multiple-dose

A

A multiple unit container for articles intended for parenteral administration only.

Antimicrobial preservation is required

Maximum volume:30 mL

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13
Q

Multiple-unit

A

Permits withdrawal of successive portions of the contents without changing the strength, quality, or purity of the remaining portion.

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14
Q

Unit of Use

A

Contains a specific quantity of a drug product that is intended to be dispensed as such without further modification except for the addition of appropriate labeling.

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15
Q

Advantages for Unit of Use

A

A dosage form can be dispensed in the manufacturers original container, thus recognizing the suitability of the container based on stability studies

The counting and repackaging of dosage units in the pharmacy is eliminated, thereby reducing the possibility of human error.

The pharmacist is able to affix the label for the patient onto the unit-of-use package and is free to use the manufacturers expiration date as the beyond use date.

The number of dosage units in a single unit-of-use package may be determined on a case-by-case basis. Patient compliance is improved.

The unit-of-se package can protect against counterfeiting because traceability of product is ensured through bar coding techniques and NDC numbers. What are these numbers???

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16
Q

Container Selection

A

The type of package selected is determined by the physical and chemical properties of the product and its protective needs. The materials selected:

  1. Must protect the preparation from environmental conditions
  2. Must not be reactive with the product
  3. Must not impart to the product tastes or odors.
  4. Must be nontoxic
  5. Must be FDA approved
  6. Must be adaptable to commonly employed high-speed packaging equipment
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17
Q

Glass

A

A liquid of a high degree of viscosity that it appears to exist as a solid. earliest evidence of manufactured glass in the form of nontransparent beads dates from ca 3500 BC in Mesopotamia.

Oldest piece of Egyptian glass is a large ball-bead bearing the cartouche of Amenhotep (1551-1527BC)

In 1912, heat-resistant glass was developed by incorporating borax in the mix. First commercial glass (pyrex) was offered in 1915.

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18
Q

Types of Glass

A

The USP provides chemical resistance tests for glass containers. They are designed to determine the resistance to water attack.

The degree of attack is determined by the amount of alkali released from the glass.

19
Q

Type 1 Glass

A

Borosilicate glass (6% boron)

Highly resistant (low leachability; low level of the non-network-forming oxides); a substantial part of the alkali and earth cations are replaced by boron and/or aluminum and zinc

Sometimes sulfur dioxide treatment is used for enhanced resistance

20
Q

Type 2 Glass

A

Treated soda lime glass

Commercial soda lime glass that has been dealkalinized (treated to remove surface alkali)

Sulfur Treatment: Sulfur dioxide is used, under controlled temp and humidity conditions, to neutralize the alkali oxides on the interior surface of the container—-> making the glass more resistant. “Weathering” is prevented

Type 2 may be suitable for a solution that is buffered, has a pH below 7 or is not reactive with the glass.

Usually has a lower concentration of migratory oxides than type 3

21
Q

Type 3 Glass

A

Sode-lime Glass. Usually will be suitable principally for anhydrous liquids or dry powders.

22
Q

Plastics

A

Composition - a plastic is a material that contains as an essential ingredient one or more polymeric organic substances of large molecular weight.

Solid in its finished state and at some stage in its manufacture or processing into finished particles can be shaped by flow.

There are over 100 different polymers available for use in packaging.

23
Q

Lubricants:

Additive

A

Assist in processing of plastic during molding or extrusion operation. A commonly used lubricant for polyethylene (PE) is zinc stearate

In tablet manufacturing, magnesium stearate is used as a lubricant.

24
Q

Stabilizers:

Additive

A

Retard or prevent degradation of the polymer by heat and light, during manufacturing

Also, they improve its aging characteristics.

Ex. Fatty acids and inorganic oxides

25
Q

Plasticizers:

additive

A

Achieve softness and flexibility. They are used commonly in vinyls and cellulosics.

26
Q

Antioxidants:

Additive

A

Assist in retarding oxidation

27
Q

Antistatic agents:

Additive

A

Prevent the buildup of static charges on the plastic surface

28
Q

Slip agents:

Additive

A

Added primarily to polyolefins to reduce the coefficient of friction of the material

29
Q

Dyes and pigments:

Additive

A

Added to impart color

30
Q

Polymers used: Polyethylene (PE)

A

2 types LDPE and HDPE

31
Q

HDPE (polymer)

A

More crystalline, better moisture barrier, more heat-resistant, and stiffer than LDPE

Most widely used plastic. Good barrier against water, but relatively poor against oxygen.

High resistance to most solvents and chemicals. It is unaffected by strong acids and alkalis. It is tasteless and odorless.

Lacks clarity and has a relatively high rate of permeation of essential odor, flavor, and oxygen.

HDPE is used widely where rigidity and barrier properties are preferred

Can be sterilized with steam and ethylene oxide. LDPE can only be sterilized with ethylene oxide.

32
Q

PE is susceptible to..

A

oxidative degradation

33
Q

Polypropylene

A

Lighter than PE but much more stiffer and more heat resistant.

Lacks Clarity

Excellent moisture barrier

Resistant to solvents

Used widely for solid dosage parts

Can be sterilized with steam and ethylene oxide

34
Q

Poly vinyl chloride (PVC)

A

Glass like clarity

Used in manufacture of blood bags, examination gloves, IV solution containers and pump tubing

Flexibility: the plasticizer DEHP is mostly used.

DEHP is toxic

35
Q

Polystyrene

A

Widely used for fabrication of containers and syringes

Lacks impact strength; used for solid dosage forms not liquid products

Rigid and transparent

36
Q

Nylon

A

Polyamide.

High water transmission rate. Low oxygen transmission

Laminates of PE and nylon: resistant to both water and oxygen

37
Q

Acrylics

A

Low water transmission rate

Used in adapters of IV solution administration sets and blood collection sets

38
Q

Cellulosics

A

The cellulose alcohol groups are esterified with acetic, butyric and/or propionic acid

Used in articles such tubing and membranes in dialyzers

Membranes for sterile filtration

39
Q

Permeation

A

Transmission of gases, vapors, or liquids through the plastic material can adversely affect the stability of the drug.

Loss of volatile components

Permeation rate is influenced by both temp and relative humidity

Molecules do not permeate through crystalline zones. HDPE vs LDPE

Nylon (hydrophillic) vs PE (hydrophobic). Laminate.

40
Q

Leaching

A

Plasticizers, colorants, and other additives removed by contents.

Toxic effect in parenterals.

41
Q

Sorption

A

Removal of constituents from contents by container.

Adverse effects, potent drugs and preservatives concentration decreased —-> low dose or no protection

42
Q

Chemical Attack

A

This can result in changes in color, viscosity, or potency. Also, haze or precipitate and variation in pH of aqueous preparations.

Increase temp and increase humidity —–> Increase rate of chemical reaction (attack)

43
Q

Modification

A

Physical and chemical alteration of the container by the drug product

Permeation, leaching and sorption are factors in modification

Flexibility of container can be affected by extraction of plasticizers

Stability is affected by the loss of antioxidants or other stabilizers

Packaging (1 decks)

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