Vaccine:storage Conditions

8/22/2019 Vaccine:storage Conditions

1/23

Storage Requirements of Vaccines

from Production to Distribution

Prepared by:

A. K. M. Radowan Ahmad

Md. Shamimuzzaman

Md. Mohiuddin


2/23

Avaccine is a biological preparation that improves immunityto a particular disease.

Typically contains an agent that resembles a disease-causingmicroorganism, and is often made from weakened or killed

forms of the microbe, its toxins or one of its surface proteins.-Stimulates the body's immune system to

recognize the agent as foreign, destroy it, and

"remember" it, so that the immune system

can more easily recognize and destroy anyof these microorganisms that it later

encounters.


3/23

Bangladesh is very much developed in theproduction of vaccines. Some of the mostimportant vaccines are developed by the leading

companies like Square, Novartis, Incepta. Small companies are also producing vaccines

recently. For instance, the 5 primary vaccines: Diptheria

Pertussis Tetanus

Polio

Measles & Tuberculosis


4/23

We consulted a pharmacist whom we know personally,Sarder Fahim Hossain, Executive, Product ManagamentDepartment (PMD), Square Pharmaceuticals.

His comments were:With disappointment, we have to say that

Bangladesh has yet not been able to developenough refrigerators which are especially used tostore vaccines.

Only one primitive type is present in SquarePharmaceuticals. The rest of the companies usethe common refrigerators which we use at home.


5/23

Vaccines must be stored properly fromthe time they are manufactured untilthey are administered to:

patients

manufacturer to distributor

distributor to office

office to patient


6/23

Live vaccines

most tolerate freezing

deteriorate rapidly after removal from storage

Inactivated vaccines

damaged by exposure to temperature fluctuations (extreme heat orfreezing temperatures)

Potency negatively affected by extended or multiple temperatureexcursions

Recommended temperatures (by USP):

Freezer: Between -58F and +5F (-50C to -15C) 5F (-15C) or colder ifonly varicella and zoster vaccines in freezer

Refrigerator: Between 35F and 46F (2C to 8C)

Average: 40F (5C)


7/23

Develop and maintain written routine plan for:

ordering and accepting vaccine deliveries;

storing and handling vaccines;

managing inventory; and, managing potentially compromised vaccines

Develop and maintain written emergency vaccine retrievaland storage plan

backup storage location with appropriate storage

units, temperature monitoring capability, andbackup generator

adequate coolers or refrigerated truck


8/23

Select carefully; use properly; maintain regularly; monitorconsistently

Consult immunization program for any specific

requirements Keep an equipment logbook

equipment serial number

equipment installation date

dates of routine maintenance- dates of service/repairs and contact information

on service provider

- equipment instructions


9/23

Stand alone freezer and refrigerators without freezersare strongly recommended (frost-free or automaticdefrost preferred)

Freezer and refrigerator compartments must each have

own exterior door and thermostat controls Able to maintain required temperature range

throughout year Dedicated to storage of biologics

Large enough to hold year's largest vaccineinventory without crowding (including fluvaccine)


10/23

Use calibrated thermometers with a Certificateof Traceability and Calibration from an ISO17025 accredited testing lab, NIST, or another

internationally recognized standards agencydigital

bio-safe liquid

continuous graphicminimum/maximum


11/23

Temperatures in both the freezer andrefrigerator units should be read and recordedtwice each day once in the morning and once before leaving

at the end of the workday Post temperature log on the door of the

storage unit

Keep temperature logs for at least 3years unless state statutes or rulesrequire a longer period


12/23

Promote good air circulation around storage unit place in well ventilated room

allow for space on all sides and top

allow minimum of 4 inches between storage unit and awall

do not block motor cover

- ensure unit stands level with at least 1-2

inches between bottom of unit and floor


13/23

Store vaccine away from unit walls, coils, andvents

Keep vaccines in original packaging

Stack in rows with same type of vaccine

Use uncovered storage containers with slottedsides or openings

Use labels with vaccine names and ageindications or color coding

Protect vaccine from light


14/23

Conduct a monthly vaccine inventory

Order vaccine responsibly based on:

projected demand

storage capacity current supply

Request delivery during office hours


15/23

Assign responsibilities to a primary

vaccine coordinator Designate at least one backup

person

Provide training and continuing

education on vaccine storage andhandling for staff


16/23

Ordering vaccines

Overseeing proper receipt and storage of shipments

Organizing vaccines within storage units(s)

Temperature monitoring of storage unit(s) at leasttwice daily

Recording temperature readings on log

Daily physical inspection of storage unit(s) Rotating stock so that vaccine closest to its

expiration date will be used first


17/23

Monitoring expiration dates and removing expiredvaccine

Responding to potential temperatureexcursions Overseeing proper vaccine transport Maintaining storage and handling

documentation Maintaining VFC program documentation

in participating clinics Ensuring adequate staff training


18/23

Plug unit directly into wall; do NOT use multi-stripoutlet

Use a plug guard or safety-lock plug

Install a temperature alarm Label circuit breakers

Use water bottles in the refrigerator

and ice packs in the freezer tomaintain temperature


19/23

Do NOT store vaccine in vegetable/fruit bins, delidrawers, or doors

Perform daily inspection of storage unit(s)

If other biologics must be stored in the same unit,store then BELOW the vaccines to avoidcontamination

Never store food and beverages in the

same unit with vaccines Take immediate corrective action when

there is a problem


20/23

Expiration dates:

Monitor vaccine and expiration dates closely

Rotate stock so that vaccine and diluent with shortest

expiration dates are used first If normal in appearance and stored and handled properly,

product can be used

through end of day indicated if expiration date is

mm/dd/yyyy (e.g., 12/15/2012 - use through 12/15/2012)- through end of month indicated if expiration date

is mm/yyyy (e.g., 12/2012 - use through12/31/2012)


21/23

Multidose vials

can be used through expiration date on label unlessotherwise stated in manufacturer's productinformation

mark with date first opened

Reconstituted vaccine

- once reconstituted use within timeframeindicated by manufacturer or discard

Never use expired vaccine


22/23

We need to be very careful about the storage of

vaccines because they are directly administered

into our bloodstream. Slight contamination can result in fatal effects.

So, it is important for all pharmaceuticalcompanies to follow all the conditions

required for vaccine storage as mentionedby the USP.


23/23

Vaccine:storage Conditions

Documents

Transcript of Vaccine:storage Conditions