The 3rd International Conference on Management of Technology, Innovation, and Project, 2021

RISK ASSESSMENT IN PURIFIED WATER SYSTEM (PWS) USING

FMEA AND FUZZY PRIORITIZATION AT PHARMACEUTICAL
COMPANY

Broto Dhegdo Haris Pranoto

Department of Technology Management, Institut Teknologi Sepuluh Nopember (ITS),
Surabaya 60111 Indonesia, E-mail: brotodhegdo@gmail.com

Mohammad Arif Rohman

Department of Industrial Engineering, Institut Teknologi Sepuluh Nopember (ITS),
Surabaya 60111 Indonesia, E-mail: arif@ce.its.ac.id

ABSTRACT
Purified Water System (PWS) is an equipment which produce water that is mechanically
filtered or processed to remove impurities and make it suitable for use. PT XYZ is a
pharmaceutical company that uses water as the main basic material to produce medicine.
The water quality to be used must meet the requirements given by the United States
Pharmacopeia (USP) and the Indonesia Food and Drug Administration (BPOM), regarding
three parameters, namely conductivity, TOC and microbiology. There have been some
problems during the existing operation of PWS consist of not optimal flow process, filter
blocking which causes growth of microorganism, inaccurate chemical adjustment during
operation. We use the same approach to risk assessment in the Pharmaceutical industry
conducted by Yücenur, Çataltepe, and Sakin (2020). This paper aims to assess potential
risks that might occur as well as formulating risk control to a new purified water system
using Failure Mode and Effect Analysis (FMEA) and Fuzzy Prioritization. FMEA has been
extensively used for examining potential failures in products, processes, designs, and
services. It integrates a quantitative process for assessing risk based on three indicators
consists of Severity (S), Occurrence (O), and Detection (D). Fuzzy FMEA is the
development of the FMEA method which provides flexibility to accommodate uncertainty
due to the vagueness of the information possessed or subjective preference elements used in
the assessment of the failure mode that occurs. It was used to evaluate the failures and to
formulate prevention action based on Risk Priority Number (RPN). There are 22 risks that
have been identified and according to the analysis had an RPN value which are higher than
72. These 22 risks need to be controlled by mitigation measures during the implementation
of the new PWS life cycle process.

Keywords: Purified Water System (PWS), Failure Mode and Effect Analysis (FMEA),
Fuzzy Prioritization.

1. INTRODUCTION
Water is a major part of the pharmaceutical industry and water is used to prepare sterile
and non-sterile product materials, wash hands during production and before the drug production
process (Sandle, 2015). Since water is one of the critical factors in the pharmaceutical industry,
microbiological control of the water used is very important. Because in water, every level of its
parameters used in the pharmaceutical industry has the potential to cause contamination from
microbiology when not controlled properly (Geldreich, 1985). The main source of water used in
the pharmaceutical industry to make medicines is water produced from the purification process
using the Purified Water System (PWS). As our case study is in one of the pharmaceutical
companies in Indonesia, which is the water quality to be used must meet the requirements given
by the United
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States Pharmacopeia (USP) and the Indonesia Food and Drug Administration (BPOM). Therefore
a prior to the PWS installation process, it is necessary to carry out a risk assessment to ascertain
what potential risks may occur, so that risks can be minimized. One method is using Failure Mode
and Effect Analysis (FMEA) combined with Fuzzy. Fuzzy FMEA is the development of the
FMEA method which provides flexibility to accommodate uncertainty due to the vagueness of the
information possessed or subjective preference elements used in the assessment of the failure
mode that occurs (Braglia et al. 2003).

2. LITERATURE REVIEW
2.1. Purified Water Systems (PWS) in Pharmaceutical Industry
This purified water system is a critical unit of equipment in the pharmaceutical industry. It
has the main function in producing Purified Water (PW) with the provisions according to the
parameters (as shown in Table.1) of the conductivity, TOC, and Microbiology level of purified
water system in the pharmaceutical industry (Kartono et al. 2014). In general, for the system,
namely pretreatment, particle filtering, and water treatment, the main thing is Reverse Osmosis
(RO), with conductivity control after the sterilization process through Ultraviolet (UV) Rays.
Based on the literature review that has been presented, the basic technology of the purified water
system (Mazzola, 2006). The water purification process technology in the pharmaceutical industry
is in accordance with the Velio Pharmaceutical Pure Water Guide, consisting of an initial
purification stage where the main goal at this stage is to remove impurities from the water source
to be treated. At a minimum, it can filter the growth of bacteria. In addition, at this stage, it is
necessary to consider the quality of the water source. Therefore, that it can ensure the right unit to
be installed to reduce operating costs for the repair and replacement process due to some tool
components have high prices. Treatment units in purified water systems can be divided into 3,
namely: 1. Basically, the reaction of chemical processes often occurs simultaneously coagulation
and flocculation. In water treatment facilities, the coagulant will be added to the water and will
quickly mix. Therefore, coagulants will be circulated and filter to get free water over particle
contamination (Peterson, 2001). 2. Membrane process technology for Purified Water (PW). It
utilizes a Reverse Osmosis (RO) membrane. Which is used to remove contaminants with a
diameter of less than 1 nm. RO is able to remove 90 to 99% of ionic contaminants, the majority of
which are organic contaminants and some particulate contamination from the water source to be
treated (Paul, 2002). The last process is Electrode ionization (EDI). In accordance with the Velio
Pharmaceutical Pure Water Guide, the EDI is one that combines an ion exchange resin and ion-
selective membrane using the direct current to remove ionized species from water EDI is widely
used in purified water generation which is implemented in the pharmaceutical industry. Due to its
"clean" non-chemical properties and constantly produced high quality water. Each stage of the
treatment unit in the purified water system process needs identification, analysis, and response to
the potential risk using the Quality Risk Management Principle.
Table 1. Pharmacopeia (USP) Requirements for Purified Water (PW)
Properties USP
Conductivity < 1.3 µS / cm with temperature 250 C
TOC < 500 ppb
Microbiology < 100 CFU / ml

2.2. Quality Risk Management

Quality Risk Management (QRM) regulated according to International Conference on
Harmonization (ICH) Q9 is a systematic process for the assessment, control, communication, and
 The 3rd International Conference on Management of Technology, Innovation, and Project, 2021

review of risks to the quality of the drug (medicinal) product across the product life cycle.
Furthermore, the concept of QRM relies on an understanding of the terms Quality and Risk. The
term quality means the extent to which a set of inherent properties of a product, system, or process
meets the requirements (ICH Q9) and according to ISO (the International Organization for
Standardization) / IEC (the International Electrotechnical Commission) Guide 51. While the term
risk means the combination of the likelihood of a hazard occurring and asking what could cause
the hazard to occur. According to Figure 1, it starts from the initiation process, proceeds to the
Quality Risk Assessment (QRA) stage which consists of identification, analysis, and risk
evaluation, then proceeds to the risk control stage.

Figure 1. Quality Risk Management process according to ICH Q9

At the risk control stage, it is necessary to determine whether the risk will be accepted or
reduced by mitigate action. If risk control has been determined, there needs to be a risk
assessment process to ensure that each mitigation that has been determined can efficiently
reduce the level of risk identified (Mellisa et al. 2019). Risk Management tool is use Failure
Mode and Effect Analysis (FMEA). It works by analyzing all the failures that may occur
during processing and service of a product.

2.3. Failure Mode and Effect Analysis

The company has identified and prevented possible failures, this will increase customer
satisfaction. In addition, it can reduce unwanted costs during the production process when the
failure occurs. When developing new products, companies must minimize risk. The purpose of
FMEA is to analyze potential risks that may occur, before the commercial process or during the
design process, production process, distribution, and determination of the type of failure that will
be carried out during the process stages. It integrates a quantitative process for assessing risk based
on three indicators consists of Severity (S), Occurrence (O), and Detection (D) (Spreafico et al.
2017). As describe by Wang (2009), Occurrence is the probability of an event due to a failure and
the type of cause of the failure while the product is in use. Level of severity due to the potential for
failure to impact the customer and the risk of damage incurred by the consequences of the failure
that occurs. Detection of the possibility when the failure occurs so that it does not reach the
customer by using existing controls (Wang et al.2009). Meanwhile Risk Priority Number (RPN) is
a quantitative method for determining the level of risk by multiplying the severity, occurrence and
detectability rankings of the failure or event used Eq. (1) (Liu,2012).

RPN = Severity x Occurrence x Detection (1)

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2.4. Fuzzy Prioritization Method

According to the results of the literature review conducted by Yücenur (2019), fuzzy
numbers are used to prioritize RPN values with the Analytic Hierarchy Process (AHP) step
(Özfırat, 2014). In recent years Fuzzy AHP (F-AHP) is a very useful methodology for important
applications in multi-criteria decision-making problems under fuzzy operate (Wang et al. 2011),
due to human thinking and preferences are inherently imprecise, vague character hence it can be
modeled with fuzzy theory easily. In one method, the decision maker's judgment is treated by
pairwise comparison and finding the priority vector (Yu, 2002 and Bisso, 2014). Fuzzy
comparison matrix is used to evaluate the degree of Occurrence, Severity, and Detection. The F-
AHP method is divided into 2 types, namely extent analysis and geometric mean. Extent analysis
is an analytical method that does not represent the relative importance of the criteria in which the
method compares the convex fuzzy with k convex fuzzy to calculate the relative importance level
(Wang et al. 2008). Meanwhile Geometric mean is a method applied to calculate the priority of
criteria using the geometric calculation G1 = (li, mi, ui) (Kuzairi et al. 2017). Where l represents
lower, m represents middle, and u represents upper. In the AHP method, the comparison between
the criteria uses a scale of 1-
9. While the F-AHP must transform the TFN (Triangular Fuzzy Number) as shown on Table 2 to
the AHP scale (Ansori, 2012 and Adnyana et al. 2016).
Table 2. Linguistic scale for the relative importance
Triangular fuzzy numbers
Linguistic Scales Symbols Number Conjugate
Equally Important E1 1, 1, 1 1, 1, 1
Weakly more important WI 2/3, 1, 3/2 2/3, 1, 3/2
Strongly more important SI 3/2, 2, 5/2 2/5, ½, 2/3
Very Strongly more important VSI 5,2, 3, 7/2 2/7, 1/3, 2/5
Absolutely important AI 7/2, 4, 9/2 2/9, ¼, 2/7

3. METHODS
To confirm the effectiveness of the research tool in the evaluation and analysis of the
causes and risks of potential faults in the new Purified Water System, this study bases the
identification, analysis, and risk control settings using Failure Mode and Effect Analysis (FMEA).
This refers to the Quality Risk Management process under ICH Q9.

3.1. Initiate Quality Risk Management (QRM)

In this methodology, quality risk management will be initiated on the development of
existing problems in accordance with the stages of the process regulated in ICH Q9 by conducting
initial communication to decision makers (Decision Maker) to get sponsorship.

3.2. The stages of FMEA

The team that will be involved has obtained approval from the decision makers. The team
will conduct a Focus Group Discussion (FGD) to conduct a Failure Mode and Effect Analysis
(FMEA) in identifying risks. The team involved is the same person in conducting risk assessment
and control on the old, purified water system, which consists of Quality Assurance Personnel,
Engineer, Analyst from the laboratory, QRM Facilitator, and Production Supervisor. FMEA
consists of three stages (Yücenur, 2019), in the beginning and defining stage, operational flow
chart is specified and information about the process is explained, the type and reason of failure is
defined. In analysis and assessment stage, risky situations are defined, potential reasons of failure
are classified in order to reach the best quality goals with the least possible cost, and in decision-
making stage the priorities and actions of FMEA analysis are defined.
 The 3rd International Conference on Management of Technology, Innovation, and Project, 2021

3.2.1. Identifying risks and fuzzy comparison matrixes for occurrence, severity, and detection
According to Özfırat (2014)’s study, in FMEA model firstly the risk factors are
identified, then fuzzy comparison matrixes are generated for occurrence, severity and
detection. The Criteria of Severity, Occurrence and Detection in our case study as shown
on Table 3, Table 4, and Table 5.
Table 3. Criteria of Severity
Category Quality/Regulatory Patient Safety
Significant quality impact such that the effects may Effects may cause serious adverse health
Catastrophic cause a Health Authority to suspend the consequences, permanent disability, or
Manufacturing/Marketing Authorization. death.
Failure to meet product quality specifications. Effects may cause a significant impact to
Critical Effects may lead to serious/critical regulatory patient health (e.g., temporary or medically
observations and/or lead to a product recall. reversible health problem or disability).
Effects may lead to nonconformance with internal Effects are noticeable by user and may
quality standards, procedures or regulatory make product unusable; requires medical
Major
requirements, leading to product quality impact or intervention.
to major regulatory observations.
Effects may lead to minor nonconformance with Effect is noticeable by user and may make
internal quality standards, procedures or regulatory product difficult to use; does not require
Moderate requirements with no product quality impact. any medical intervention.
May result in minor observations or
recommendations in regulatory inspections.
Effects will not lead to nonconformance with Effects will have negligible to no impact to
Minor/ internal quality standards, procedures, or patient health.
Negligible regulatory requirements. No product quality
impact.

Table 4. Criteria of Probability of occurrence

Category Criteria Customization Notes for Probability of Occurrence (if used)
Certain to occur
Very High More than 14 events within last 2 years
routinely
High Occurs frequently 9 - 14 events within last 2 years
Moderate Occurs occasionally 5 - 8 events within last 2 years
Low Has not occurred often 1 - 4 events within last 2 years
Extremely unlikely to
Remote No event since last 2 years
occur

Table 5. Criteria of Detection

Category Criteria
Remote There is no established inspection, testing, or monitoring in place to detect the failure.
Low There is limited inspection, testing, or monitoring in place. Detection is delayed and multiple
failures may go undetected between consecutive steps.
Moderate Some inspection, testing, or monitoring is in place. Detection is delayed and single failure could go
undetected between consecutive steps
High Inspection, testing, or monitoring is in place. There is a high probability that the failure will be
detected within the step.
Very High Consistent inspection, testing, or monitoring is in place to immediately and consistently detect the
failure.

The questionnaire can be performed for the comparison of the importance or

preference of risk according to others for understanding the importance degree of the risks
for each other. Based on the Triangular fuzzy number according to Table 2, then evaluate
the determination of the degree of Severity, Occurrence and Detection with the Cheng's
(1996) model through an extent analysis approach. Based on the Triangular fuzzy number
according to Table 2, then evaluate the determination of the degree of Severity,
Occurrence and Detection with the Cheng's (1996) model through an extent analysis
approach.
The 3rd International Conference on Management of Technology, Innovation, and Project, 2021

Determine the object, namely X = {x 1, x2, …..xn} and the goal is U = {u1, u2,… um }. Due
to the method of Cheng's (1996) extent analysis of each object to show each goal (g i), then
each object, namely the m extend analysis, is written as Eq. (2)
𝑀1 , 𝑀2 ,……, 𝑀𝑚 , i= 1,2,…, n, (2)
𝑔𝑖 𝑔𝑖 𝑔𝑖

While the triangular fuzzy value is (3)

From the description above, the next steps are:
a. Fuzzy synthetic extent
(4)
After that calculate, for additional fuzzy operations on m extent analysis,

(5)
And get,
, for additional fuzzy operations on

(6)
Inverse Vector Calculation, (7)
b. Determination of the degree of probability

is (8)
or similar with Eq. (9)
(9)

Where,
d= ordinate of the highest point of intersection D between µ𝑀1 and µ𝑀2 , to V (𝑀1 ≥
𝑀2 ) and V (𝑀2 ≥ 𝑀1)
c. The degree of probability for a convex fuzzy number is more than k convex fuzzy
numbers
𝑀1 (I = 1,2,…,k) is V (M ≥ 𝑀1, 𝑀2, …..𝑀𝑘 ) = V [ (M ≥ 𝑀1) and (M ≥ 𝑀2)
and…..(M ≥ 𝑀𝑘)] = minV ((M ≥ 𝑀𝑖), (i=1,2,…k) (10)
assumption that
(11)
Which k = 1,2,…n ; k ≠ i. then weight vector is
(12)
where, 𝐴𝑖 (i=1,2,….n), n is elements.
d. Normalization of the value of the weight vector

(13)
W is nonfuzzy number
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3.2.2.Determining importance coefficients (weight vectors) by fuzzy prioritization method

The determination of the most important coefficients (Weight Vectors) using the
fuzzy prioritization method is carried out after obtaining the fuzzy matrix. In each matrix
comparison, the equations that can be used are the following equations (Yayla, 2013)
W Occurrence = (𝑤𝑂, 𝑤𝑂, 𝑤𝑂, …………., 𝑤 𝑂 ) (14)
1 2 3 𝑛
W Severity = (𝑤𝑆, 𝑤 𝑆 , 𝑤 𝑆 , …………., 𝑤 𝑆 ) (15)
1 2 3 𝑛
W Detection = (𝑤𝐷, 𝑤 𝐷 , 𝑤 𝐷 , …………., 𝑤 𝐷 ) (16)
1 2 3 𝑛

3.2.3. Converting the importance coefficients (weight vectors) into FMEA degrees
According to Wang (2009) that the most important coefficients (weight vectors) are
the probability values of risk events according to each other. This value can be obtained
using the FMEA conversion. First, the risk that has the highest Occurrence value is given
the symbol P1. Furthermore, the overall risk of Occurrence, Severity and Detection scoring
can be seen in the following Table 6 - 8 (Özfırat, 2014).
Table 6. Severity coefficient conversion using fuzzy prioritization method into FMEA
A B C D
Risk Weight Vector for Severity Severity (The highest value Degree by according to
from Table 3) coefficients
R1 S1 S1
𝑤1𝑆 𝑆
R2 - S1. (𝑤 / 𝑤𝑆)
𝑤2𝑆 2 1
….. ….. - …..
𝑆
Rn
𝑤𝑛𝑆 - S1. (𝑤 /
𝑛
𝑤1𝑆 )
Table 7. Occurrence coefficient conversion using fuzzy prioritization method into FMEA
A B C D E
Risk Weight Vector for Occurrence (The Occurrence Degree
Occurrence highest value from By coefficients (According to Table 4)
Table 4)
R1 P1 - O1
𝑤1𝑂 𝑂
R2 - P1. (𝑤 / 𝑤𝑂) O2
𝑤2𝑂 2 1

….. ….. - ….. ….

𝑂 𝑂
Rn - P1. (𝑤 / 𝑤 ) On
𝑤𝑛𝑂 𝑛 1

Table 8. Detection coefficient conversion using fuzzy prioritization method into FMEA
A B C D
Risk Weight Vector for Detection Detection (The highest value Degree by according to
from Table 5) coefficients
R1 D1 D1
𝑤1𝐷 𝐷
R2 - D1. (𝑤 / 𝑤𝐷)
𝑤2𝐷 2 1
….. ….. - …..
𝐷
Rn
𝑤𝑛𝐷 - D1. (𝑤 /
𝑛
𝑤1𝐷 )

3.2.4. Finding RPN values

For all risks the RPN values are calculated by Equation (1). In an evaluation of RPN
value if RPN value is less than 72 then there is no need for precaution. However, if RPN
value ≥ 72 the company must take precautions and suggestions for reducing RPN values
(Referring to the internal Standard Operating Procedure (SOP) provided by the company
where the case study is conducted)
 The 3rd International Conference on Management of Technology, Innovation, and Project, 2021

4. RESULTS AND DISCUSSION

4.1. Identifying Risks
In the study, the FMEA technique has been used, and how at engineering services department
to operating the purified water system (PWS) processes were studied. The problems were defined
and how these problems affect the workflow was also found out. The risk identified as shown in
Table 9.
Table 9. Identification Risk

4.2. Developing fuzzy pairwise comparison matrixes

In fuzzy prioritization method the AHP method is performed firstly. In fuzzy AHP, the
questionnaire can be performed for the comparison of the importance or preference of risk
according to others for understanding the importance degree of the risks for each other. The 23
identified risks (as show in Table 9) were weighted for each component, namely severity,
occurrence, and detection by decision makers (weighted criteria follow Table 2). The results of the
pairwise comparison matrixes are shown in Figure 2 – 4. It was show fuzzy assessment matrixes
for severity, occurrence, and detection of the risks respectively for Purified Water Systems.

Figure 2. Fuzzy pairwise comparison matrix for severity of risks in purified water system

Figure 3. Fuzzy pairwise comparison matrix for occurrence of risks in purified water system
 The 3rd International Conference on Management of Technology, Innovation, and Project, 2021

Figure 4. Fuzzy pairwise comparison matrix for detection of risks in purified water system

4.3. Computing importance coefficients with fuzzy prioritization method

After operating fuzzy AHP steps we calculated weight vectors for three dimensions such as severity,
occurrence, and detection. The result as show on Table 10.
Table 10. Importance coefficients computed by fuzzy prioritization method

4.4. Converting importance coefficients into FMEA degrees and calculating RPN values
The importance coefficients which are given in Table 10 is converted FMEA degrees as
shown on Table 11.
Table 11. Computing occurrence, severity, detection degrees

After calculating the degrees of occurrence, severity, and detection, the RPN values are computed
according to Eq. (1). The calculated RPN values and mitigating action are shown in Table 12.
Some RPN values shown in these tables are higher than 72. That’s mean we have to suggest
proactive and reactive precautions (mitigating action) for these risks.
 The 3rd International Conference on Management of Technology, Innovation, and Project, 2021

Table 12. RPN Values and mitigating action

5. CONCLUSIONS
In this paper, we applied FMEA technique with fuzzy prioritization method for a pharmaceutical
company. Failures and risks were determined in a Focus Group Discussion by QRM Teams. For
all potential risk’s severity, detection and occurrence values were determined. As a result, 22 Risk
identified for new purified water system an RPN value which are higher than 72. Risk reduction or
control actions are required. Risk control recommendations for all high and medium risks must be
reviewed and approved by Decision Makers. Proposed risk control actions and individual or group
responsibilities for these actions must be documented. If a high risk cannot be further reduced,
formal acceptance must be documented and approved by Site Quality and Operations Head. This
process can be realized by investments to be made on the equipment, employees, and supplier.

ACKNOWLEDGEMENTS
The authors wish to thank the administration support of PT XYZ which is one of the
Pharmaceutical companies in Indonesia as our case study. The authors would also like to thank the
Director Plant Management, Associate Directors Engineering, and all other team members at the
Engineering and Quality department for their support and help.

REFERENCES
Adnyana, T. G. A. F., Gandhiadi, G. K., & Nilakusmawati, D. P. E., (2016). Penerapan Metode
Fuzzy AHP Dalam Penentuan Sektor Yang Berpengaruh Terhadap Perekonomian Provinsi
Bali. E-Jurnal Matematika 5(2), 59
 The 3rd International Conference on Management of Technology, Innovation, and Project, 2021

Ansori, Y. (2012). Pendekatan Tringular Fuzzy Number Dalam Metode Analytic Hierarchy Process.
Jurnal Ilmiah Foristek 2(1), 126–135.
Bisso, C.S., and Samanez, C.P. (2014). Efficient determination of heliports in the city of Rio De
Janerio for the Olympic games and world cup: A fuzzy logic approach. International Journal
of Industrial Engineering 21 (1), 33-44.
Braglia, M., Frosolini, M., & Montanari, R.(2003). Fuzzy criticality assessment model for failure
modes and effects analysis. International Journal of Quality & Reliability Management, Vol.
20 (4), 503 - 524
Geldreich, E.E., Taylor, R.,H, Blannon, J.C. and Reasoner, D.J. (1985). Bacterial Colonization of
Point-of-Use Water Treatment Devices, J Am Water Works Assoc, Vol.77. No.2, pp.72-80
G. Nilay Yücenur, (2019). Integrating Fuzzy Prioritization Method and FMEA in the Operational
Processes of an Automotive Company. International Journal of Knowledge-Based
Organizations 9(3) 14-32
Kartono. R. and Basuki Y.T. (2014). Strategic of Applying Free Chemical Usage In Purified Water
System For Pharmaceutical Industry Toward CPOB (Cara Pembuatan Obat yang Baik)
Indonesia To Reducing Environmental Pollution, EDP Sciences, 00039-p.1 – p.7.
Kuzairi, Faisol, & Pramiswari, T. (2017). Penentuan Tembakau Berkualitas Menggunakan Fuzzy
AHP. Jurnal Ilmiah NERO, 3(2), 101–108
Liu, H.C., Liu, L., Liu, N. and Mao, L.X., (2012). Risk evaluation I failure mode and effects
analysis with extended VIKOR method under fuzzy environment. Expert Systems with
Application, 39. pp 12926-12934.
Mazzola, P.G., Martins, A.M and Penna, T.C. (2006). Chemical resistance of the gram-negative
bacteria to different sanitizers in a water purification system, BMC Infectious Diseases volume
6, Article number: 131
Paul, D.H. (2002). Electrode ionization in pharmaceutical water treatment, Pharmaceutical
Technology north America; Jul; 26, 7; ProQuest Research Library. pp. 36
Peterson, H.G. (2001). Rural Drinking Water and Waterborne Illness, Safe Drinking Water
Foundation Saskatoon, SK. pp. 162 – 186
Sandle T. (2015).Characterizing the Microbiota of a Pharmaceutical Water System-A Metadata
Study, Symbiosis Group. SOJ Microbiol Infect Dis 3(2): 1-8.
Sandle T. (2016).Assessment of pharmaceuticals water Systems, Pharmaceuticals Microbiology,
Essentials for Quality Assurance and Quality Control, Woodhead Publishing, pp. 115-129
Spreafico, C. Russo, D. and Rizzi, C., (2017).A state-of-the-art review of FMEA/FMECA
including patents. Computer Science Review, 25. pp. 19-28
Wang, Y.M and Chin, K.S. (2011).Fuzzy analytic hierarchy process: A logarithmic fuzzy
preference programming mythology. International Journal of Approximate Reasoning,
52(4).pp.541-553
Wang, Y.M., Chin, K.S., Poon, G.K.K and Yang,J.B. (2009) .Risk evaluation in failure mode and
effects analysis using fuzzy weight geometric mean. Expert Systems with Application, 36. pp
1195-1207.
Wang, Y. M., Luo, Y., & Hua, Z. (2008). On the extent analysis method for fuzzy AHP and its
applications. European Journal of Operational Research 186(2) ; 735-747
Yayla, A.Y. and Yildiz, A. (2013).Fuzzy Analytic Network Process based multi criteria decision
making methodology for a family automobile purchasing decision. South African Journal of
Industrial Engineering, 24. pp. 1 – 14.
Yu, C.S. (2002). A GP-AHP method for solving group decision-making fuzzy AHP problems.
Computers & Operation Research, 29 (14). Pp. 1969-2001