QC LEC - Packaging Material

PACKAGING

• affects the quality, stability, and identification of drug product

• provide an adequate degree of protection, minimize the loss of constituents, and should not interact physically or chemically with the contents in a way that will alter their quality to an extent beyond the limits given in the individual monograph, or present a risk of toxicity

MECHANICAL HAZARDS

• shock

• compression

• puncture

• vibration etc.

ENVIRONMENTAL HAZARDS

• temperature

• pressure

• moisture

• gases

• light

• contamination etc.

NEUTRAL GLASS

borosilicate glass

SODA-LIME SILICA

silica glass containing alkali metal oxides (sodium oxides) and alkaline earth oxides (calcium oxides)

POWDERED GLASS TEST

• performed on ground/powdered glass to expose internal surface

• estimates the amount of alkali leached from the glass powder

• alkali treated with 0.02 N sulphuric acid

WATER ATTACK TEST

• exposure of the glass with Sulphur dioxide at 121 °C

• to determine the alkali leached from the surface of the container is within the specified limits or not

TYPE 1

Treated borosilicate (suitable for most preparations)

TYPE 2

Treated soda lime (for acidic and neutral, aqueous preparation)

TYPE 3

Soda lime (non-aqueous preparation for parenteral and non parenteral)

Type 4 (nonparenteral)

General purpose

CRACKS

partial fractures generally found in the heel, sometimes at the shoulder

FREAKS

odd shapes and conditions that render container completely unusable

FILAMENTS

hair-like string inside the bottle

IN VIVO

• Latin: "within the living"

• it refers to work that's performed in a whole, living organism

IN VITRO

• Latin: "within the glass"

• when something is performed in vitro, it happens outside of a living organism

Packaging

is the art and science which involves preparing the articles for transport, storage, display and use

Pharmaceutical packaging

means of providing protection, presentation, identification, information, and convenience to encourage compliance with a course of therapy

Primary Packaging Material

come in direct contact with the product itself

Secondary Packaging Material

• does not come in direct contact w/ the product

• serve as accessory to the primary packaging component

Leaker's Test

performed by producing negative pressure within an incompletely sealed ampule while the ampule is in the solution

Clarity of Aqueous Extracts

clear in dark or light background with no floating particles

CLOSURE

• is the part of the package which prevent the contents from escaping

• allow no substance to enter the container

CONTAINER

• for a pharmacopoeial article intended to contain a drug substance or drug product with which it is, or may be in direct contact

• the closure is a part of the container

Well-closed containers

protects the contents from loss during transportation, handling, storage, or sale

Single dose containers

are used to supply only one of medicament and hold generally parenteral products

Multi dose containers

• allow the withdrawal of dose at various intervals without changing the strength, quality, or purity of remaining portion

• hold more than one dose and are used for injectables

Light-resistant containers

• protect the medicament from harmful effects of light

• used to store those medicaments which are photosensitive

Air-tight containers

• hermetic container

• have air-tight sealing or closing

• protect products from dust, moisture and air

Air-tight sealed containers

used for injectables

Air-tight closed containers

meant for the storage of other products

Aerosol containers

• used to hold aerosol products

• have adequate mechanical strength in order to bear the pressure of aerosol packing

TORQUE

a measure of circular force required to loosen the cap (unit of force: inch per pound)

APPLICATION TORQUE

amount of force used to tighten the cap

LINER

may be defined as any material that inserted in a cap to effect a seal between the closure and the container

Homogenous liner

• are one piece liners available as disk or a ring of rubber or plastic

• can be withstand high temperature sterilization

Heterogenous liners

• composed of layers of different materials chosen for specific requirements

• consists of facing and backing

Polyethylene Terephthalate

Fizzy drink and water bottles, salad trays.

High-Density Polyethylene

Milk bottles, bleach, cleansers, and most shampoo bottles.

Polyvinyl Chloride

Pipes, fittings, window and door frames (rigid PVC), thermal insulation (PVC foam), and automotive parts.

Low-Density Polyethylene

Carrier bags, bin liners, and packaging films.

Polypropylene

Margarine tubs, microwaveable meal trays, also produced as fibers and filaments for carpets, wall coverings, and vehicle upholstery.

Polystyrene

Yoghurt pots, foam hamburger boxes, and egg cartons. Expanded _______________ is used for packaging for electronic goods and toys, insulation material in the building and construction industry.

Unallocated References

Any other plastics that do not fall into any of the above categories. For example, polycarbonate, which is often used in glazing for the aircraft industry.