Setting Acceptance Criteria for a National Flocked Swab for Biological Specimens during the COVID-19 Pandemic
Corresponding email: yudan.whulanza@ui.ac.id
Published at : 27 Nov 2020
Volume : IJtech
Vol 11, No 5 (2020)
DOI : https://doi.org/10.14716/ijtech.v11i5.4335
Whulanza, Y., Supriadi, S., Chalid, M., Kreshanti, P., Agus, A.A., Napitupulu, P., Supriyanto, J.W., Rivai, E., Purnomo, A., 2020. Setting Acceptance Criteria for a National Flocked Swab for Biological Specimens during the COVID-19 Pandemic. International Journal of Technology. Volume 11(5), pp. 888-899
| Yudan Whulanza | 1. Department of Mechanical Engineering, Faculty of Engineering Universitas Indonesia, Kampus UI Depok, Depok 16424, Indonesia 2. Research Center for Biomedical Engineering (RCBE), Universitas Indone |
| Sugeng Supriadi | 1. Department of Mechanical Engineering, Faculty of Engineering Universitas Indonesia, Kampus UI Depok, Depok 16424, Indonesia 2. Research Center for Biomedical Engineering (RCBE), Universitas Indone |
| Mochammad Chalid | Department of Metallurgy and Material Engineering, Faculty of Engineering Universitas Indonesia, Kampus UI Depok, Depok 16424, Indonesia |
| Prasetyanugraheni Kreshanti | 1. Plastic Reconstructive and Aesthetic Surgery Division, Department of Surgery, Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jl. Salemba Raya no. 6, Jakarta 10430, Indones |
| Anna Amalyah Agus | Department of Management, Faculty of Economics and Business, Universitas Indonesia, Kampus UI, Depok, Depok 16424, Indonesia |
| Paulus Napitupulu | Soebekti Hambali Learning Center, Dynapack Asia Pte Ltd, Royal One Phillip No.03-01, 1 Phillip Street, 048692, Singapore |
| Joni W. Supriyanto | Ingress Malindo Ventures, Jl Industri Selatan 6A Jababeka II, Bekasi, 17520, Indonesia |
| Edi Rivai | Chandra Asri Petrochemical Tbk, Wisma Barito Pacific Tower A, Letjen S. Parman Kav 62, Jakarta 11410, Indonesia |
| Andri Purnomo | Toyota Auto Body-Tokai Extrusion, MM2100 Blok LL-3, Bekasi 17520, Indonesia |
Swab sticks are a means of sampling a person by
swabbing the nasopharyngeal pathway. This tool is at a critical point, where
domestic availability in Indonesia is lacking because it is purely dependent on
foreign supplies during the coronavirus disease 2019 (COVID-19) pandemic. The
procurement process takes weeks or even months. Therefore, a collaboration of
national companies with different industrial backgrounds and the Research
Center for Biomedical Engineering, Universitas Indonesia, addressed this scarcity
by developing and producing a national swab stick. Since there was no swab
stick manufacturer in Indonesia, the production was arranged in such a way from
four different industries, following ISO 13485:2016, Medical Devices – Quality
Management Systems – Requirements for Regulatory Purposes’. The companies
contributing have strong experience in resin production, plastic processing,
flocking technology, and medical packaging. However, it is important to ensure
that the quality of the product developed meets the quality of existing
products. This manuscript summarizes the quality assurance of the swab stick
design, prototype, and production. Here, we propose a series of measurements;
namely, geometrical, tensile, peel, surface, flock adsorption, and residue
testing. The conclusion shows that the developed swab stick has stiffness
around 400 MPa, deflected at 15N, a density of 1.5–2.5 Dtex, water contact
angle at 78 degrees, and adsorbs around 25–35mL of liquid water. Moreover, there was no solvent or
any toxic substance around the flocked swab during the residue testing. These
qualities shall be developed further into a national product with nearly 100%
local content in order to increase availability of the national medical device
and fight COVID-19 in Indonesia. The
product was formally registered under the trade name Sterilized Nasopharynx
Swab Stick HS 19.
COVID-19 pandemic; ISO 13485; National swab stick; Quality assurance; 100% local content
A
nasopharyngeal swab (hereafter referred to as “swab”) is a method for
collecting clinical trial samples of nasal secretions from the back of the nose
and throat (Sheridan, 2020). Samples are
then analyzed to determine the presence of organisms or other clinical markers
for disease. This diagnostic method is usually used in cases of suspected
whooping cough, diphtheria, influenza, and various diseases caused by the
coronavirus family, including severe acute respiratory syndrome (SARS), Middle
East respiratory syndrome (MERS), and coronavirus disease 2019 -COVID-19 (Pavord and Pavord, 2005; Junkins, 2010; Irving et al.,
2012).
Similar
in concept to cotton swabs, swab sticks used for nasopharyngeal collecting are
small sticks made of short plastic rods which are covered at one end with
adsorbent materials such as cotton, polyester, or nylon. Previously, swab
sticks were made from nichrome or stainless-steel wire. The swab material used
for certain diagnostic applications can vary based on the type of test
performed. Several studies have shown that flocked swabs are able to collect
greater sample volumes compared to fiber swabs (Gritzfeld
et al., 2011).
In
general, the structure of a swab stick aims to obtain a specimen from the
patient’s nasopharynx safely, but also has enough volume to be followed up with
subsequent procedures on a polymerase chain reaction machine. There are two
major parts. The first is the part that will enter the contours of the
nasopharynx, which is not straight; flexibility is needed so that it is
comfortable for patients. The stick is commonly produced by the
injection-molding method. However, an optimum operating operation and mold
design shall be defined to gain the product as required (Chalid et al., 2017; Hasnan et al., 2017; Wang et al., 2019).
The
second important part is the flocked swab which consists of nylon material, the
function of which is to hold the specimen volume of the nasopharynx without
loss when moved; therefore, the capillary structure of the flock is attached to
the surface of the swab stick. In order to fulfill this function, there are
several challenges; namely, a material and geometric form of the main material
flock swab and a flocking process that is able to make the material “stand” and
form a “crowd” (flocking) so that the capillary force is formed on the flocked
swab. The procedure can be approached in the textile industry and is usually
called the electrostatic flocking process. Electrostatic flocking uses an
electric charge to direct fibers and form a line that is perpendicular to the
surface of the substrate. This technique optimizes the results obtained with
longer fibers. In this method, the substrate is pre-coated with an adhesive and
then passed through a high-voltage electrostatic field chamber. This method can
be improved by the existence of pneumatic techniques to provide good coverage
on three-dimensional objects (Walther et al., 2007;
Basaran et al., 2012; Nunes et al., 2016).
This paper reports the testing of a flocked swab produced by our
consortium that consisted of researchers and industrial partners during the
project “Donation of National Flock Swab for Fighting COVID-19”. Our partners
have strong competency and knowledge in raw material selection, mold design,
plastic processing, flocking, packing, and sterilization processes. These
companies, all based in Indonesia, are geographically separated and located
around the Jakarta Provinces, Tangerang Provinces, and West Java Province.
Therefore, a set of acceptance criteria for the product needed to be measured
and standardized to assure quality, although communication hurdles might occur.
The project was to realize a rapid design and development of a nasopharynx swab
stick using local resources. However, the design and manufacturing processes
needed to be integrated and needed to comply with ISO 13485:2016 Medical Devices – Quality
Management Systems – Requirements for Regulatory Purposes.
Our
fabrication process, which integrates a series of industrial lines, has been
proven to produce a functional swab stick with the quality as described above.
We were also able to determine a set of protocols to assure the product
conformed to the design. It has been shown that the swab stick was developed
using designated materials, production processes, and geometries so that they
have the right stiffness properties, with a modulus of elasticity around 400
MPa. The flocked swab developed from nylon 66 has hydrophilic properties making
it easier to adsorb the biological sampling process. It can adsorb liquid
specimens at a range of 25–35 microliters. These qualities are comparable to
those commercial swab sticks that are available on the market. Note that our
production strategy uses injection molds that practically enable us to produce
a higher quantity; i.e., 1 million pieces, rather than the alternative offered
by 3D printed products.
We acknowledge the contribution of Dynapack Asia Pte Ltd, PT Chandra
Asri Petrochemical Tbk, PT Ingress Malindo Ventures, PT Toyota Auto Body-Tokai
Extrusion, PT Toyota Motor Manufacturing Indonesia, PT Langgeng Jaya Fiberindo,
PT Indachi Prima, PT Sri Tita Medika, PT Cakra Manunggal Pratama, and PT
Samudra Montaz. The development was supported by the Direktorat Inovasi &
Science Techno Park, Universitas Indonesia.
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| R1-ME-4335-20201025115634.pdf | Version 3 |
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