Chapter 16
Completing
Product
Processing
By the end of this chapter,
you will be able to:
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Explain the term cold chain
Describe the type of fridge
used for correct storage of
refrigerated products
List three factors that affect
the stability of a product
Explain the reasons for using a
validated transportation process
Introduction
Products can become unsafe or unusable for
patients unless the correct storage conditions
are maintained.
A product can deteriorate in three ways:
chemically, physically or microbiologically.
Temperature, light and incorrect handling
can all affect the stability of a product so it is
very important to follow the correct storage
requirements for each product.
In this chapter we will look at storage,
labelling, packaging and transportation
of aseptic preparations.
Describe how to label syringes,
IV bags, infusion devices
Describe three main types
of packaging used
List some of the labels
you might find on
transportation packaging
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Aseptic Processing
What do these temperature
ranges mean?
Some products are stored
at a temperature of up
to 25° C This is referred
to as ‘room temperature’
or ambient temperature. The temperature
of storage areas needs to be controlled and
monitored as it can fluctuate throughout the
year depending on the outside temperature.
The majority of products,
once prepared, require a
temperature of 2° to 8° C
and so must be stored in a fridge. When a
product is refrigerated, it significantly slows
down microbial growth which can reduce the
risks for patients.
The Cold Chain
When an item that requires refrigeration is
made, it is important to ensure that the product
stays under the right conditions to maintain its
integrity until it is required by a patient.
This control process is called the cold
chain. The temperature must be maintained
within acceptable limits throughout the
transport process.
Products that need refrigeration can
deteriorate if they are not stored at the correct
temperature and therefore must be placed in a
fridge as soon as possible after preparation.
Refrigerated products are delivered to clinical
areas in a cool box or bag with a cool pack and
are placed in a fridge again as soon as possible
after delivery or at the point of delivery.
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Chapter 16: Completing Product Processing
Refrigerated items should be removed just
prior to use and any unused items returned
to the fridge as soon as possible.
Information: Products should not be
administered to patients immediately from
the fridge. They should be allowed to warm
up to room temperature.
Shelf Life
The shelf-life of a product should reflect its
intended use and administration and should
take into account, for example, prolonged
storage at skin or body temperature.
Some products that are stable at room
temperature can be refrigerated to decrease the
risk posed by potential microbial contamination.
Information: You must check the
manufacturer’s instructions.
Stability
Many sources of information about stability exist
and it is the responsibility of the pharmacist
in charge of the facility to ensure that the
information used in stability determination is
scientifically valid and accurate.
Suitable data should be sought and evaluated
before products are prepared.
Stability should be assessed to ensure that the
quality of the product is suitable for the patient
at the time of administration.
Chapter 16
Completing Product Processing
Test Yourself
Complete the following sentences:
A product can deteriorate in three ways: ……………., ……………… or ……………………......
………………........……, …...........…….. and ………..………………. can all affect the stability
of a product.
Correct Refrigeration
The fridge used for storage must comply with
certain requirements and be suitable for use.
Products should be spread out in the fridge,
to aid circulation of cold air around them and
hence to speed up and increase the efficiency
of chilling.
Products should be chilled prior to transportation,
except if the time between preparation and
delivery to the point of use is minimal.
Chilling should be for a minimum of 4-6 hours
to effectively cool the whole contents of the
container.
Temperatures should be read and
recorded daily.
A fan-assisted fridge is required – a domestic
fridge is not suitable for use!
The movement of air in the fan-assisted fridge
will decrease the chances of hot and cold
spots. The temperature of the product will be
brought down more rapidly.
The fridge needs to have much larger capacity
than the amount that is intended to be placed
in it. This will allow for air circulation and
to ensure that the fridge is not running to
maximum capacity all the time.
The temperature should be monitored constantly.
A maximum/minimum thermometer should be
placed in the fridge to show if the temperature
limit has been exceeded or if the minimum
temperature has not been reached.
Chapter 16: Completing Product Processing
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Aseptic Processing
All fridges used to store pharmaceuticals need
to be temperature mapped annually. This is
to show that all parts of the storage area stay
within the design limits of 2oC to 8oC.
Task
Fridge temperature records should be
maintained either electronically or manually.
1.
List five products that need protection
from light:
These records should be held for at least 1
year and in some cases longer.
(See your local procedure).
2.
Effect of Light
3.
4.
5.
Light can damage some pharmaceutical
compounds and this is especially true of
natural light which is of higher energy than
artificial light.
List five ingredients that need to be stored
between 2oC and 8oC:
2.
3.
4.
Photodegradation is a problem for pharmaceutical
compounds in solution and it is usual practice to
protect all products from light wherever possible
during storage and distribution.
Some products are so light sensitive that
they require protection from light during
administration.
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Chapter 16: Completing Product Processing
5.
Chapter 16
Completing Product Processing
Transportation
Correct Labelling
Products should be distributed using a
validated process to ensure the cold chain
is not broken and to ensure the product is
suitably protected during transportation.
After a product has been visually checked
it should be labelled. Before starting the
labelling process:
Hazardous products such as cytotoxics should
be handled carefully to prevent damage and
leakage, to avoid harm to those handling them.
Items not requiring refrigeration should be sent
via a validated transport mechanism which
protects the product during transportation and
ensures product quality upon delivery.
When transporting products that require
refrigeration, the temperature of the products
must be maintained within acceptable limits
throughout the transport process.
This can be achieved by using cool boxes
and cold packs.
These boxes may be colour coded to show
they contain for example Parenteral Nutrition
solutions or cytotoxic drugs.
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the area should be clean and free from
other products;
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the area should be free from other labels
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Line clearance or bench clearance logs are
used to record this.
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One product should be processed at a time
to avoid a mix up.
When labelling syringes some general
guidance is:
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1-10ml syringes should be flagged around
the barrel of the syringe.
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20-50ml syringes should have the label on
the barrel parallel to the graduations.
Whatever the method of distribution, the
container must be moved safely, maintaining
the cold chain and the integrity of the product.
On receipt of refrigerated items, the products
should be unpacked and immediately
refrigerated, prior to use.
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Aseptic Processing
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It is good practice to arrange the label on
the syringe with the plunger to the right of
the text. (Most people are right handed and
this means the label is most easily read).
Once the product has been labelled it
should be placed in an area designated
for final checking.
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Don’t forget the documentation!
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The number of labels used should be
recorded on the label reconciliation
section of the worksheet.
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Any unused labels should be documented,
defaced to prevent further use and
placed in the plastic sleeve.
(Check your local procedures.)
After final checking the different product
types must continue to be segregated. This
means cytotoxic products, Parenteral Nutrition
products and CIVA are all kept separate.
When labelling infusion bags:
IV Bags should have the label placed over the
original contents of the bag but not covering
the name of the base solution.
The text on the label should be in the same
direction as the text on the infusion bag.
The label should not cover critical information,
such as warnings.
Infusion devices should have the label in an
appropriate position to ensure that it can be
clearly seen and read. The label should not
cover any critical information on the device.
All products should be stored under
refrigeration unless it would be detrimental to
the product to do so.
Batches of the same product that have
been produced at the same time should
be stored together.
Packaging
There are three main types of packaging.
Primary Packaging – Packaging which has
direct contact with the product.
This should be suitable for purpose and
should ensure that the product remains fit for
use. For example, PVC bag, *Ethylene-vinylacetate (EVA) bag, polypropylene syringe, etc.
The primary packaging must be compatible with
the product and not release anything into it.
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Chapter 16: Completing Product Processing
*Ethylene-vinyl-acetate is a type of plastic, used for its
good compatibility with Parenteral Nutrition ingredients
Chapter 16
Completing Product Processing
Transport packaging
Products should be transported in rigid, leak
proof containers capable of containing spills
and maintaining the cold chain when required.
Containers should be clearly marked with the
destination and originating department.
Tamper evident seals should also be used
where possible.
Secondary Packaging – This is not in direct
contact with the product.
Dark outer packaging is used when the
product needs to be protected from light.
This adds further protection to the product and
enables a second patient label to be added.
Products should be protected from light and
damage. Common practice is to overwrap the
product with clear polythene to prevent leaks
and enable people to read the label.
Secondary opaque packaging can be used as
light protection and can be colour coded to aid
identification in clinical areas.
Cytotoxic products require specific packaging
to highlight the need for safe handling.
Heat sealing also provides a tamper evident
seal and can prevent leaks.
Supplementary labelling can be added to the
secondary packaging e.g. cytotoxic hazard
label, additional storage requirements, order
of use labels.
For cytotoxic products, transport boxes should
contain emergency contact information and
instructions for safe handling in case of spillages.
Chapter 16: Completing Product Processing
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Aseptic Processing
Further Reading: Refer to Chapter 19
Cytotoxic Preparation for more information on
transporting cytotoxic preparations.
An indication of the storage temperature must
be displayed when refrigeration is required.
An indication of the storage temperature must
be displayed when room temperature storage
is acceptable.
Flat packaging is used for products that need
to be stored flat.
A CD sticker must be applied for controlled
drugs that have to be locked in a CD cupboard.
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Chapter 16: Completing Product Processing
Chapter 16
Completing Product Processing
Activity
Make sure you watch the following videos at:
http://www.medslearning.leeds.ac.uk/pages/aseptics/videos.html
and then refer to your local procedures:
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Labelling a 1ml syringe video 21
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Labelling a 10ml syringe video 22
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Labelling a 50ml syringe video 23
If there are any variations in your local procedures, make a note of them below.
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Aseptic Processing
Questions
Q1
Explain what we mean by the Cold Chain and why it is important to maintain this chain.
(4)
Q2
List three factors that can affect the stability of a product and steps you can take to
protect against them.
1.
2.
3.
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Chapter 16: Completing Product Processing
Chapter 16
Completing Product Processing
Q3
What are the rules for labelling each of the following?
1-10ml syringe:
20-50ml syringe:
IV bags:
Infusion devices:
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Aseptic Processing
Q4
Name and describe the purpose of three main types of packaging.
(6)
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Chapter 16: Completing Product Processing