Exam 2 Packaging Flashcards
A _______ holds the article or may be in direct contact with the article. The _______ _____ is that which is in direct contact with the article at all times.
Container
Immediate container
T or F: The closure is part of the container
True
Special precautions and cleaning procedures may be necessary to ensure that each container is clean and that extraneous matter is not introduced into or onto the _____.
article
T or F: No physical or chemical interactions between the container and the contents that might result in altering the strength, quality, or purity of the stored article beyond official requirements
True
Tamper resistant packaging is used for what type of products?
Opthalmic, otic, or OTC
Light resistant containers are used for compounds prone to ______. A container may be made light resistant by means of _____ coloring.
Oxidation
Opaque
Well closed containers protect from extraneous ______ (solids, liquids, and/or gas) and from loss of the drug under the ordinary or customary conditions of handling, shipment, storage, and distribution
Solids
Well closed containers are used for solid dosage forms not prone to ______ or _____
Oxidation or hydrolysis
Tight container protect the contents form contamination by extraneous _____ (solids, liquids, and/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
solids, liquids, and vapors
T or F: Tight containers are not capable of tight re-closure
False: tight containers are capable of tight reclosure
The loss of water of hydration in hydrates
Efflorescence
The absorption of water vapor
Deliquescence
Which containers are impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution
Hermetic
T or F: 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
True
Packaging 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
Single-unit
Single-dose containers are a single-unit container for articles intended for ______ administration, with no antimicrobial preservation required. The maximum volume is ___L
Parenteral administration
1 L
A single-unit container for articles intended for administration by other than the parenteral route as a single dose, direct from the container
Unit-dose
Multiple-dose includes multiple-unit containers for articles intended for ______ administration only. Antimicrobial preservation ____ (is / is not) required. The maximum volume is ____mL
30mL
Container that 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
Unit-of-use containers
T or F: The container must protect against adverse effects of the environments and must prevent loss of drug product components
True
T or F: The materials selected for the container do not need to be FDA approved
False; they need to be FDA approved
T or F: Glass is a liquid of a high degree of viscosity that it appears to exist as a solid
True
In the composition of glass, a structural network is formed by ______ ______
Silicon oxide
____ oxide can enter the structural network, but most other oxides cannot
Boric oxide
Most common cations in pharmaceutical glassware include (8)
Silicon Boron Aluminum Sodium Potassium Calcium Magnesium Barium
T or F: In glass, many useful properties are affected by the kind of elements presents, such as lead in small traces can give clarity and brilliance
True
T or F: The USP provides chemical resistance tests for glass containers, which are designed to determine the resistance of new glass containers to water attack
True
T or F: The degree of attack in chemical resistance testing is determined by the amount of acid released from the glass under the influence of the attacking medium under specific conditions
False; alkali released
T or F: The volume of 0.02 N sulfuric acid required to neutralize the alkalinity leached from the test material should not exceed certain value specified for each type of glass
True
Type I glass
Borosilicate (6% boron)
Type I glass is ____ (highly/ not highly) resistant, with ____ (high or low) leachability. A substantial part of the alkali and earth cations are replaced by boron and/or aluminum and zinc
Highly
Low leachability
The level of the non-network forming oxides is known as
Leachability
T or F: Type I glass is suitable for all products, but because of cost, one of the other less expensive types may be acceptable
True
Type II glass
Treated soda-lime glass
Type II glass undergoes _____ treatment with _____ _____, which neutralizes the alkali oxides on the interior surface of the container, making the glass more resistant and prevents “weathering”
Sulfur treatment with sulfur dioxide
T or F: Type II may be suitable for a solution that is buffered, has a pH above 7, or is not reactive with the glass
False; has a pH below 7
T or F: Type II usually has a lower concentration of migratory oxides than Type III
True
Type III glass
Soda-lime glass
T or F: Type III soda lime glass will be suitable principally for anhydrous liquids or dry powders
True
T or F: NP Soda-lime glass is also suitable for containers for parenterals
False; not suitable for parenterals
Which types of glass undergo a powdered glass test?
Types I, III, and NP
What type of glass undergoes a water attack test?
Treated soda-lime glass
What is the limit in mL of 0.020 N Acid for Type I glass?
1.0
What is the limit in mL of 0.02 N Acid for Type II glass that is 100mL or less?
0.7
What is the limit in mL of 0.02 N Acid for Type II glass that is over 100mL?
0.2
What is the limit in mL of 0.02 N Acid for Type III glass?
8.5
What is the limit in mL of 0.02 N Acid for NP glass?
15
Advantage of glass include ______, _______, and _____.
Inertness, visibility, and stability
T or F: Any other material proposed by a manufacturer is tested agains glass as the standard before use for drug packaging
True
A material that contains as an essential ingredient one or more polymeric organic substances of large molecular weight
Plastic
T or F: There are over 100 different polymers available for use in packaging
True
Material that assists in processing of plastic during the molding or extrusion operation. A commonly used substance for polyethylene is zinc stearate
Lubricant
Material that retards or prevents degradation of the polymer by heat and light, during manufacturing, as well as improves its aging characteristics
Stabilizers
Classes of common stabilizers (2)
Fatty acids, inorganic oxides
Common lubricant for PE
Zinc oxide
Material that achieves softness and flexibility and are used commonly in vinyls and cellulosics
Plasticizers
Material that assists in retarding oxidation
Antioxidants
Material that prevents the buildup of static charges on the plastic surface
Antistatic agents
Material added primarily to polyolefins (polyethylene and polypropylene) to reduce the coefficient of friction of the material
Slip agents
Material added to impart color
Dyes and pigments
Most widely used plastic that is a good barrier against water, but relatively poor against oxygen
Polyethylene
What are the two types of polyethylene?
Low density or branched: LDPE
High density or linear: HDPE
_____ (LDPE/HDPE) is more crystalline, better moisture barrier, more heat-resistant, and stiffer than _____ (LDPE/HDPE)
HDPE; LDPE
T or F: Polyethylenes have a high resistance to most solvents and chemicals, are unaffected by strong acids and alkalis, and are tasteless and odorless.
True
T or F: Polyethylenes lack clarity and have a relatively low rate of permeation of essential odor, flavor, and oxygen
False; have a relatively high rate of permeation
_____ (LDPE/HDPE) is used widely where rigidity and barrier properties are preferred, such as in bottles of solid dosage formes
HDPE
_____ (LDPE/HDPE) is used where flexibility is required, such as in squeeze bottles of sprays and drops
LDPE
T or F: HDPE can be sterilized with ethylene oxide only, while LDPE can be sterilized with steam and ethylene oxide
False: HDPE sterilized with steam and ethylene oxide
LDPE sterilized with only ethylene oxide
______ is lighter than PE but much stiffer and more heat resistant. It _____ (has / lacks) clarity, is a _______ (poor/excellent) moisture barrier, and is ________ (susceptible/resistant) to solvents
Polypropylene
Lacks clarity
Excellent moisture barrier
Resistant to solvents
Polypropylene is used widely for ____ (solid/liquid) dosage products and can be sterilized with (steam and/or ethylene oxide)
Solid dosage products
Steam and ethylene oxide
Plastic that has glass-like clarity, and is used in the manufacture of blood bags, examination gloves, IV solution containers and pump tubing
Polyvinyl chloride (PVC)
What is the most commonly used plasticizer in PVC to add flexibility
DEHP
T or F: DEHP is toxic
True
Widely used for fabrication of containers and syringes, but lacks impact strength i.e. used for solid dosage forms and not liquid products
Polystyrene (PS)
T or F: PS is rigid and non-transparent
False; PS is rigid and transparent
Nylon is a ______ with a ______ (high/low) water transmission rate, and a (high/low) oxygen transmission
Polyamide
High water transmission
Low oxygen transmission
T or F: Laminates of PE and nylon are resistant to both water and oxygen
True
Class of plastics that includes polymethacrtylates, polyacrylates, and copolymers of acrylonitrile
Acrylics
Acrylics have a ____ (high/low) water transmission rate and are used in adapters of IV solution administration sets and blood collection sets
Low water transmission rate
Cellulose alcohol groups are esterified with which three types of acids?
Acetic, butyric and/or propionic acid
T or F: Cellulosics are used in articles such as tubing and membranes in dialyzers for sterile filtration
True
The transmission of gases, vapors, or liquids through the plastic material that can adversely affect the stability of a drug
Permeation
Permeation rate is influenced by both _____ and relative ______
Temperature and relative humidity
T or F: Molecules do not permeate through crystalline zones
True
T or F: Nylon is hydrophobic while Polyethylene is hydrophilic
False: Nylon = hydrophilic
PE = hydrophobic
When plasticizers, colorants, and other additives are removed by contents and can have a toxic effect in parenterals
Leaching
The removal of constituents from contents by the container that can result in adverse effects such as a decrease in potent drugs and preservative concentration which can cause low doses or no protection
Sorption
When chemical reactions between plastic and drug in contact result in changes in color, viscosity, or potency, as well as haze or precipitate
Chemical attack
Increasing temperature and humidity (increases/decreases) the rate of chemical attack
Increases
The physical and chemical alteration of the container by the drug product, in which permeation, leaching, and sorption are also factors.
Modification
T or F: PE containers are deformed due to permeation of gases and vapors or loss of contents through the walls i.e. oils soften PE
True
T or F: Flexibility of a container can be affected by extraction of plasticizers
True
Biological tests for plastics are designed to test the suitability of plastic material intended for use in fabricating containers and accessories for use in ______ preparations and for use in _____ devices, implants, and other systems
Parenteral preparations and medical devices and implants
Biological tests the reaction of living animal tissue and animals to the presence of the _____ or extracts of it is determined
plastics or extracts
Biological reactivity test to evaluate systemic response; tested in albino mice
Systemic injection test
Biological reactivity test to evaluate local response; tested in albino mice
Intracutaneous test
Biological reactivity test in direct contact with living tissue where strips of plastic are implanted into rabbits
Implantation
Four types of physiochemical tests (4)
- Nonvolatile residue
- Residue on ignition
- Heavy metals
- Buffering capacity
Determines the moisture permeability when packaging and storage in a tight container or a well-closed container is specified
Moisture permeation test
Classification of a tight moisture permeation test
Exceeds 100mg/day/liter in not more than 1 of the 10 test containers. Exceeds 200 mg/day/liter in none of them
Classification of a well-closed permeation test
Exceeds 2000 mg/day/liter in not more than 1 of the 10 test containers, and exceeds 3000mg/day/liter in none of them
In a light transmission test for plastic containers, the products intended for oral or topical administration does not exceed 10% at any wave length in the range of ____ to ____ nm
290-450 nm
Category one of recycling plastics
PETE
Category two of recycling plastics
HDPE
Category three of recycling plastics
V
Category four of recycling plastics
LDPE
Category five of recycling plastics
PP
Category six of recycling plastics
PS
_____ can leach bisphenol A, a potential hormone disruptor, into liquids, which is controversial in baby bottles
Polycarbonate
