part 2 - container

Container

– a device that holds a drug and is,

or may be, in direct contact with the

drug.

Well-closed

it protects the

contents from

extraneous solids and

from loss of the drug

under ordinary

conditions of handling,

shipment, storage and

distribution

Tight container

– protects the contents

from contamination by

extraneous liquids,

solids or vapors from

loss of the drug and

from efflorescence,

deliquescence or

shipment, storage and

distribution

Light-resistant

containers

– containers that

prevent photochemical

decomposition of

substances that are

photosensitive

Hermetic container

– container that is

impervious to air or any

other gas under the

ordinary or customary

conditions of handling,

shipment, storage and

distribution

-25°C and -10°C

(-13 and -14oF)

Freezer

Not exceeding 8°C

(46oF)

Cold

Controlled 2-8°C

(36 & 46oF)

Refrigerator

8-15°C

(46 and 59oF)

Cool

30oC-40oC

Warm

Above 40oC

Excessive heat

Protect below 0oC

Protection from

freezing:

Controlled Cold

Temperature

–Thermostatically

controlled between 2°C

and 8°C with allowed

excursions between

0°C and 15°C as long

as the mean kinetic

temperature (MKT)

does not exceed 8°C

Room Temperature

– the ambient

temperature in the

room

Controlled Room

Temperature

– Thermostatically

controlled between 20oC

and 25oC with allowed

excursions between 15oC

and 30oC and transient

spikes up to 40oC as long

as the MKT does not

exceed 25oC and spikes

do not exceed 24 hours