Manufacturing (SAS 4)

SAS 4

Granulation

Granulation

to impart good flow properties to the material and increase the apparent density of the powders

Drying

most common conventional method of drying a granulation through a circulating hot oven

Fluidized-bed dryers

an attractive alternative to the circulating hot air ovens

Type 316

the most commonly used stainless steel

Colloid mill

consists of a fixed stator plate and a high-speed rotating rotor plate

Positive displacement pumps

pumps that don’t apply excessive shear and doesn’t incorporate air

Sand

almost pure silica

Soda ash

sodium carbonate

Limestone

Calcium carbonate

Cullet

broken glass which act as fusion agent

Boron oxide

helps in the melting process

Lead

gives clarity and brilliance

Aluminum oxide

used to increase hardness and durability

Blowing

uses compressed air from molten glass in the cavity of a metal mold

Drawing

molten glass is pulled through dies or rollers that shape the soft glass

Pressing

mechanical force is used to press the molten glass against the side of a mold

Casting

uses gravity or centrifugal force to cause molten glass to form in the cavity of the mold

Type I: Borosilicate Glass

the addition of 6% boron reduces the leaching action

Type II: Treated Soda-lime glass

soda lime glass that has been de-alkalized or treated to remove surface alkali

Type III: Regular Soda-lime Glass

containers are untreated and made of commercial soda-lime glass of average or better-than-average chemical resistance

Type NF: General Purpose Soda-lime Glass

containers made of soda-lime glass are supplied for nonparenteral products those intended for oral or topical use

Polyethylene

most widely used plastic material for containers by the pharmaceutical industry and is a good barrier against moisture

Polypropylene

does not stress-crack under any conditions and has a high melting point making it suitable for boilable packages

Polyvinyl Chloride (PVC)

clear, rigid and can be produced with crystal clarity and provide a fairly good oxygen barrier

Polystyrene

a rigid, clear plastic used for containers for solid dosage forms a

Polycarbonate

can be made into a clear transparent container and has the ability to be sterilized properly

Polyethylene terephthalate

a condensation polymer with excellent impact strength

Sorption

the removal of constituents from the drug product by the packaging material

Metal

an attractive container that permits controlled amounts to be dispe

Tin

preferred for foods, pharmaceuticals, or any product for which purity is a paramount consideration and is the most chemically inert of all collapsible tube metals

Aluminum

offer significant savings in product shipping cost and provide the attractiveness of tin at somewhat lower cost

Lead

has the lowest cost of all tube metals and usd for such products as fluoride toothpaste

Linings

if the product is not compatible with bare metal, the interior can be flushed with wax-type formulations

Plastic

has a unique ‘suck-back’ feature which prevents product ooze

Laminations

containing several layers of plastic, paper, and foil, fabricated from flat, printed stock

Closures

the most vulnerable and critical component of a container

Threaded Screw Cap

when the screw cap is applied, its thread engage with the corresponding threads molded on the neck of the bottle

Lug

an interrupted thread on the glass finish

Crown Caps

commonly used as a crimped closure

Closure liners

any material that is inserted in a cap to effect a seal between the closure and the container

Homogeneous liner

one-piece liners that are available either as a disk or as a ring of rubber or plastic

Heterogeneous liner

it consists of two parts: a facing and a backing

Rubber stoppers

used primarily for multiple-dose vials and disposable syringes

Tamper-resistant packaging

it has an indicator or barrier which provides evidence that tampering has occurred

Film wrappers

used for products requiring package integrity or environmental protection

End-folded wrapper

formed by pushing the product into a sheet of overwrapping film

Fin Seal

it does not require the product to act as a bearing surface against which the overwrap is sealed

Shrink wrapper

the packaging of a product in a thermoplastic film that has been stretched and oriented

Blister Package

capable of providing excellent environmental protection and provides user functionality in terms of convenience, child resistance, and tamper resistance

Strip Package

a form of unit dose packaging that is commonly used for the packaging of tablets and capsules

Bubble Pack

it is usually formed by sandwiching the product between a thermoformable, extensible, or heat-shrinkable plastic film

Shrink Banding

it makes use of the heat-shrinking characteristics of a stretch-oriented polymer

Bottle Seals

a bottle may be made tamper-resistant by bonding an inner seal to the rim of the bottle

Tape Seals

involves the application of a glued or pressure-sensitive tape or label around or over the closure of the package

Roll-cap designs

used in the past for carbonated beverages and uses an aluminum shell

Ratchet-style design

the bottom portion of the closure has a tear-away strip which engages a ratchet on the bottle neck