5cb72916

ATLANTIC TECHNOLOGICAL UNIVERSITY

SEMESTER 2 SOLUTIONS 2022/2023

MODULE: ENGI07059 - Biomaterials

PROGRAMME(S):
GA_EBIOG_H08 BACHELOR OF ENGINEERING (HONOURS) IN
BIOMEDICAL ENGINEERING
GA_EBIOG_B07 BACHELOR OF ENGINEERING IN BIOMEDICAL
ENGINEERING

YEAR OF STUDY: 3

EXAMINER(S):
Mr. DAVID MC DONNELL (Internal)
Dr. Philip Griffin (External)
Dr. Catherine Deegan (External)

TIME ALLOWED: 2 Hours

INSTRUCTIONS: Answer 4 questions. All questions carry equal marks.

PLEASE DO NOT TURN OVER THIS PAGE UNTIL YOU ARE INSTRUCTED TO DO SO.
Programmable or text storing calculators, smart phones/watches or any other electronic devices are
expressly forbidden in the Examination Hall.

Requirements for this paper:

1. Non-Programmable Calculators Allowed

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 1 of 9
5cb72916

QUESTION 1 (Solutions) [TOTAL MARKS: 25]

Q1 [5 Marks]
i. The product could be reprocessed however the possibility of
introducing additional contaminants into the sterility process should
prevent the engineer from reprocessing the product(s). It is the
responsibility of the engineer to ensure the upmost of prevention in
terms of quality assurance.

ii. The oxide layer should be identified and recorded (Charaterised via SEM,
XPS, contact angle etc). The parts should be inspected prior to sterility
and contaminants should be recorded. Bioburden should be checked and
compared to previous measures, and this will indicate if there is an issue
in the process or an issue with the sterilisation process.

Results of the bioburden – similar bioburden – address sterility

issues and sterility process. SAL should be checked.
Increase in bioburden – the process needs to be checked across
each step with the spike in bioburden indicating the process with issue.

All steps to be recorded and liaised with the quality teams.

iii. Titanium specimens are typically sterilized with autoclave, gamma

irradiation, oxygen plasma, or ultraviolet light. Considering these
options oxygen plasma should be eliminated as there is a requirement
to move away from the oxygen that is accelerating the oxide growth.

As auto clave uses steam it would also be advisable to move away from
this type of sterilisation process.

Gamma irradiation or UV would be the most suitable depending on the

products dimensions and geometry as UV is poor for no surface
sterilisation.

Once the most suitable sterilisation process was achieved a

characterisation process should be implemented to ensure that the
oxide growth has been monitored and is being controlled. The manner
of characterisation and monitoring should be agreed with the quality
department and implanted with engineering. Should the oxide layer be
very variable the engineering team may use r-charts rather than process
capability control depending on the multitude of factors.

[End of Solutions of Question 1]

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 2 of 9
5cb72916

QUESTION 2 (Solutions) [TOTAL MARKS: 25]

Q 2(a) [5 Marks]
Covalent bonding involves the sharing of electrons between two or more atoms. These
bonds mostly occur between nonmetals or between two of the same (or similar)
elements. They generally have the following properties: high hardness, high
compressive strength, and chemical inertness.

Q 2(b) [20 Marks Total]

i.

Any one of these and its corresponding application;

[5 Marks]
ii.

In order for a temporary support device to work properly, a gradual stress transfer
should occur: As the natural tissue heals, the degradable implant should gradually
weaken.

[5 Marks]

iii. The need to adjust the degradation rate of the temporary support device to
the healing of the surrounding tissue represents one of the major challenges
in the design of such devices.

It is important to minimize premature polymer degradation during fabrication

and storage. Traces of moisture can seriously degrade even relatively stable
polymers during injection moulding or extrusion. Degradable polymers are
particularly sensitive to hydrolytic degradation during high-temperature

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 3 of 9
5cb72916

processing. The industrial production of degradable implants therefore often

requires the construction of “controlled atmosphere” facilities where the
moisture content of the polymer and the ambient humidity can be strictly
controlled. After fabrication, γ -irradiation or exposure to ethylene oxide may
be used for the sterilization of degradable implants. Both methods have
disadvantages and as a rule, the choice is between the lesser of two evils. γ -
Irradiation at a dose of 2 to 3 Mrad can result in significant backbone
degradation. Since the aliphatic polyesters PLA, PGA, and PDS are
particularly sensitive to radiation damage, these materials are usually
sterilized by exposure to ethylene oxide and not by γ -irradiation.

Unfortunately, the use of the highly dangerous ethylene oxide gas represents
a serious safety hazard as well as potentially leaving residual traces in the
polymeric device. Polymers sterilized with ethylene oxide must be degassed
for extended periods of time.

[10 Marks]

[End of Solutions of Question 2]

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 4 of 9
5cb72916

QUESTION 3 (Solutions) [TOTAL MARKS: 25]

Q 3(a) [5 Marks]
i. Material A is stronger – higher Yield and higher Ultimate tensile strength.
ii. Material B is more ductile – greater strain before failure.
iii. Material B will absorb more energy before failure (greater area under the
curve)

Q 3(b) [20 Marks Total]

i. Bioactive ceramics are generally regarded as ceramics that are designed to

induce specific biological activity for repairing damaged organs. For repairing
bone tissues, the bioactivity is regarded as the capability to make direct
contact with living bone after implantation in bony defects.
[5 Marks]

ii. Bioactive ceramics are employed as coatings to enhance the fixation of a

device or as bone graft substitutes because of their osteoconductive properties.
They act as a scaffold to enhance bone formation on their
surface. Hydroxyapatite is the most widely used bioactive ceramic material in
orthopaedic surgery. Example: hydroxyapatite (HA) coating on a hip implant -
is used as a bone substitute because of its innate chemical similarities to natural
bone. When an implant is coated with HA, it provides an osteophilic surface,
which helps the natural bone affix to the implant.

Dental solutions: bioceramics is represented by dental ceramics, which include

orthodontic devices (e.g., braces), prostheses (e.g., crowns, bridges) and
implants (e.g., all-ceramic root implants).

implantable electronics devices: feedthroughs and other elements of

pacemakers, defibrillators, neurostimulators, and cochlear implants.

Tissue engineering scaffolds: medical pumps; blood shear valves for

hematology testing; drug delivery devices; piezoelectric components for
medical tools and instruments; and ceramic-to-metal assemblies for imaging
equipment.

[7 Marks]

iii.

Bioceramics can be either bioinert or biocompatible. Bioinert materials coexist

with adjacent tissues and react minimally with them (they are almost inert),
forming an encapsulation. Biocompatible materials, instead, either form bonds

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 5 of 9
5cb72916

with hard and soft tissues (bioactive materials) or dissolve in the body and
generate new tissues (bioresorbable materials). As such, bioceramics can be
formulated to be bioinert (e.g., alumina and zirconia), bioactive (e.g., synthetic
hydroxyapatite), or bioresorbable (e.g., tricalcium phosphate).

The type of fixation depends upon the implantation device chosen by the
student – below the table gives a brief overview of the possible choices.

[8 Marks]

[End of Solutions of Question 3]

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 6 of 9
5cb72916

QUESTION 4 (Solutions) [TOTAL MARKS: 25]

Q 4(a) [5 Marks]
Single dose must be below the toxic level and above the minimum level to be
effective. The effectiveness is dependant on the patient physical attributes
(size / weight etc) and there is a possibility to be below the minimum effective
level. Multiple doses pose the risk of reaching the toxic level should sufficient
time not be adhered too or should an issue with recording occur. Ideally
release of pain medication or similar should occur in a steady state above the
minimum threshold and below the toxic level. This is where polymer controlled
drig delivery is ideal (should the design be robust).

Q 4(b) [10 Marks]

Membrane: In this delivery system the active agent is contained in a core or

“reservoir” which is surrounded by a thin polymer membrane, and release to
the surrounding environment occurs by diffusion through the rate-controlling
membrane. This system is called a “reservoir device.”

//safety of this type of device may sometimes be of concern because rupture of

the membrane can lead to sudden release of the drug within the core//

Monolithic: therapeutic agent is uniformly dispersed or dissolved in a polymer

matrix and its release is controlled by diffusion from the matrix. The matrix is
assumed to be inert.

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 7 of 9
5cb72916

Q 4(c) [10 Marks]

Poly(acrylic acid) and chitosan are some of the pH-sensitive polymers
commonly used for controlled drug delivery. The polymers may swell or
collapse depending on the surrounding pH. This behavior is usually exhibited
by the polymers with ionizable functional groups. The polymers (polyacrylic
acid) with acidic functional groups such as –COOH deprotonate at basic pH and
acquire negative charge. Similarly, the polymers (chitosan) with basic functional
groups such as – NH2 protonate at acidic pH and acquire positive charge.
Polymer molecules with similar charges repel each other and it exists in the
swollen state. However, when the pH changes, the charged functional groups
are neutralized and the polymer undergoes conformation change resulting in
the collapsed state. Such changes involving swelling and collapsing of polymer
are used to control the delivery of drugs.

[End of Solutions of Question 4]

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 8 of 9
5cb72916

QUESTION 5 (Solutions) [TOTAL MARKS: 25]

Q 5(a) [5 Marks]

In a bone replacement application, it would be more beneficial to have a metal that

closely replicates the performance of bone hence Metal D would be the best choice
here. The Youngs modulus of 25Gpa is the closest to the typical value of bone and
would prevent secondary issues such as stress shielding.

Q 5(b) [10 Marks]

Stress F
A

Force = Weight x Factor

100 x 2.5

250 kg = 2452.5 Newtons

Area = 5.6cm ^3 = 5.6 x 10-4m^2

Stress 2452.5 4379464 Pa

0.00056

Q 5(c) [10 Marks]

Strain Stress = 4379464 3.53183E-05

Youngs Modulus 1.24E+11
or 0.0035%

[End of Solutions of Question 5]

[END OF SOLUTIONS]

ENGI07059 – Biomaterials
Semester 2 Solutions 2022/2023 Page 9 of 9