Dissertation on Various Sterilization Procedures

Running head: DISSERTATION
Dissertation on various sterilization procedures (hydrogels)
Name of the Student
Name of the University
Author Note

1DISSERTATION
Executive summary
Most surgical and medical devices used across healthcare facilities are comprised of heat stable
materials, which primarily undergo steam and dry heat sterilisation. However, over the past
decades, there have been an enormous increase in the use of surgical instruments and medical
devices that are made up of plastic or gel like materials, which generally require low temperature
sterilisation. Ethylene oxide gas is used to sterilize moisture and heat sensitive medical devices.
Furthermore, low-temperature sterilisation systems employ the use of peracetic acid immersion,
hydrogen peroxide gas plasma, and ozone gas for decontaminating the medical devices that come
in contact with patient body surface. The process of sterilisation has been found effective in
destroying all pathogens present on the skin surface or on surgical instruments, thereby
preventing transmission of disease with the use of these devices. Thus, of inadequately sterilized
items increase the risk of transmitting pathogens. The dissertation will contain detailed
information on the different types of sterilisation procedures followed for hydrogel dressings in
wound healing and will also elaborate on the GMP guidelines that must be followed during the
production of these wound dressing devices.

2DISSERTATION
Table of Contents
Chapter 1: Introduction....................................................................................................................4
Background..................................................................................................................................4
Research Aim...............................................................................................................................5
Research objective.......................................................................................................................5
Research question........................................................................................................................6
Problem statement.......................................................................................................................6
Chapter 2: Literature review............................................................................................................8
I.To identify the various kinds of sterilization procedures that are utilized at healthcare
services........................................................................................................................................8
II. To recognize the best procedure that can be used for sterilizing hydrogels.........................14
III. To identify the current Good Manufacturing Practices for a range of wound dressing
devices:......................................................................................................................................19
IV. To recognize the Australian guidelines that pertain to these Good Manufacturing Practices:
...................................................................................................................................................21
Chapter 3: Methodology................................................................................................................23
Introduction................................................................................................................................23
Research design.........................................................................................................................23
Concept of systematic reviews..................................................................................................23
Question formulation.................................................................................................................25
Inclusion and exclusion criteria.................................................................................................26

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Literature search........................................................................................................................27
Data extraction and quality of appraisal....................................................................................28
Bias............................................................................................................................................28
Chapter 4: Results..........................................................................................................................30
Introduction................................................................................................................................30
Sterilisation................................................................................................................................30
Importance of sterilisation.........................................................................................................31
Sterilisation methods.................................................................................................................33
Hydrogels and their importance.................................................................................................35
Methods of hydrogel sterilisation..............................................................................................36
Therapeutic Goods Administration Australia guidelines for GMP...........................................36
Chapter 5: Conclusion and Recommendations..............................................................................38
Conclusion.................................................................................................................................38
Recommendations......................................................................................................................38
Limitations.................................................................................................................................39

4DISSERTATION
Chapter 1: Introduction
Background
Sterilization is a process that is known to eliminate or kills all forms of biological agents
like bacteria, fungi, viruses, prions and many others that are found on specified regions of many
surgical instruments, medications, biological cultural media and few others (Rutala & Weber,
2014). This process can be achieved by heating, exerting high pressure and filtration. Hydrogel is
a hydrophilic network of polymer chain and are highly absorbent. They are extremely flexible
due to their 90% of water content. The composition of hydrogel product includes a group of
polymers that are proficient of holding water in large amount in their three-dimensional
polymeric network. The polymeric network is a cross linkage between dextran and dextran
sulphate (Karperien et al., 2015). This is an insoluble polymer and is semi-occlusive in nature.
Synthetic hydrogels are more favoured because of their higher capacity of water consumption,
longevity in service and availability of raw chemicals of wide varieties. Usually many forms of
hydrogel are available, some of them are amorphous hydrogel, which is a free flowing gel,
impregnated hydrogel, which is naturally saturated, and another is sheet hydrogel, which is a
combination of these gels. There are many biomedical application of hydrogel known today.
This is widely used in dressing since it helps to control the exchange of fluid on the surface of
the wound (Fan et al., 2014). This provide an excellent moisture to a dry injury and acts by
cooling down the lesion. They are known to hydrate wound and there usage should be avoided in
wounds from which large amount of exudates are oozing out. This moisturized condition assist
in the protection of wound from any bacterial infection and this in turn helps in healing process.
Hydrogel provide a soothing effect on burns. The ingredients of hydrogel wound dressing

5DISSERTATION
include water and humectants. The main humectant is glycerin that generally attracts and binds
to the water or to the product. Beside this, it is also used in producing contact lenses, cell
therapeutics, regeneration of cartilage bone and in delivery of drugs as well (Caló &
Khutoryanskiy, 2015). Hydrogels are favoured due to their flexibility and serve as scaffolds to
provide an integrity in structure during construction of tissues. For producing contact lenses
polymeric hydrogel should have some ideal physical properties like luminous transmittance
value of minimum 95%, refractive index of 1.3, sufficient oxygen permeability and many others.
In regeneration of bones, Alginate hydrogel has been found to be a potential tool due to its
biocompatibility nature. In the purpose of cardiac repair injectable hydrogels are also used. This
injection attenuates the cardiac function after myocardial infarction. In drug delivery, hydrogels
are also used to increase the effect of the drug and to decrease the side effects simultaneously
(Yahia et al., 2015).
Research Aim
The process of sterilization involves any procedure that is focused on eliminating,
removing or deactivating all forms of life and biological agents in healthcare settings. The
primary objective of the research is to identify the importance of hydrogels and the sterilization
process that is best suited for this hydrogels.
Research objective
The research objectives are mentioned below:
 To identify the various kinds of sterilization procedures that are utilized at healthcare
services
 To recognize the best procedure that can be used for sterilizing hydrogels

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 To identify the current Good Manufacturing Practices for a range of medical devices
 To recognize the Australian guidelines that pertain to these Good Manufacturing
Practices
Research question
The research question forms the fundamental core of a study or project that encompasses
a thorough review of literature. This research question helps to focus the study and also
facilitates the process of determining the research methodology. The research question was kept
succinct and comprehensive and is given below:
What is the best sterilization procedure for hydrogels?
This research question will serve the purpose of guiding all the stages of literature search,
and analysis, followed by a reporting of the findings.
Problem statement
There are a range of benefits that can be achieved upon using hydrogel-based dressings in
healthcare settings. Hydrogels are primarily used for wound healing. These act as an excellent
hydrating source that provides moisture to the skin at the wound site, which might contain a dry
lesion. The widespread use of hydrogel as effective dressings for wound cleaning can be
attributed to the fact that these polymer gels have self-healing properties, and are able to act at a
rapid rate, thereby assisting the wound site to cool down (Kamoun, Kenawy & Chen, 2017).
These polymer gels have also been found effectiveness in providing temporary relief to patients
undergoing dressings, from the severity of pain. Therefore, hydrogels have been found to exert a
temporary analgesic effect at site of injury, for approximately six hours (Boateng & Catanzano,
2015).

7DISSERTATION
Owing to the high amount of moisture that is provided to the lesion or wound site, from
the hydrogel polymer dressings, a range of healing phases that encompass stages such as, repair
of the epidermal cells, granulation, and removal of an excess dead and damaged tissue get
facilitated. In addition to assisting the stages that are an integral part of wound healing, these
hydrogels also result in an elimination or reduction of potential discomfort from the site of injury
(Dumville et al., 2014). The high prevalence of wound infection that might be deep or superficial
signifies the need of administering sterilized dressings to prevent a deterioration of the lesion site
(Madaghiele et al., 2014).
Owing to the fact that infections that affect the wound sites are found to significantly
contribute to maximum cases of hospital acquired infections that result in an increased rate of
mortality and associated morbidity, proper efforts must be taken to recognize manage the spread
of pathogens at sites of injury (Fry, 2013). Infection can also occur during direct transfer of the
hydrogels at the dressing site, thereby contributing to contamination of the lesion region. Thus,
the research is based on discovering the appropriate sterilization procedure that will prevent
pathogen infection of the hydrogel, thereby significantly contributing to a reduction in wound
infection rates.