Vol 4, Issue 1, 2022 (199-207)
http://journal.unpad.ac.id/idjp
*Corresponding author,
e-mail : Kelvin17001@mail.unpad.ac.id (K. F. Pratama)
https://doi.org/10.24198/idjp.v4i1.39062
© 2022 K. F. Pratam et al
Effect Of The Stopping Stripping Production Line To OEE (Overall Equipment
Effectiveness) Of The Stripping Machine On The Primary Packaging Processes In The
Pharmaceutical Industry
Kelvin Fernando Pratama*1, Anis Yohana Chaerunisaa2
1Pharmacy Professional Program, Faculty of Pharmacy, Universitas Padjadjaran
2Department of Pharmaceutical and Formulation Technology, Faculty of Pharmacy,
Universitas Padjadjaran
Jalan Raya Bandung-Sumedang KM 21, Jatinangor 45363, Indonesia
Submitted : 12/04/2022, Revised : 29/04/2022, Accepted : 31/05/2022, Published : 02/06/2022
Abstract
Increased production output is the main priority in the pharmaceutical industry.
Productivity of primary packaging process which plays an important role in
producing output can be improved and maintained by conducting regular OEE
(Overall Equipment Effectiveness) analysis of the machinery and processes. OEE
is a calculation method that is carried out thoroughly to identify the level of
productivity and performance of machines or equipment. The OEE consists of three
main measurements, namely availability, performance, and quality. In this study,
line stop activities were observed during the primary packaging process that
affected the OEE value of stripping machines in one of the pharmaceutical
industries in the city of Jakarta. Research is carried out by observing, recording, and
processing data related to primary packaging processes such as line stops and the
number of products produced. Based on our study, we found that most of the line
stops in the primary packaging process are caused by the changing of the
polycellonium of the primary packaging material. Thus, we conclude that reducing
changing of the polycellonium time from 10 minutes to 5 minutes will be beneficial
to increase the operating time by 8% and increase the OEE value by 5%.
Keywords: Primary Packaging Process, Overall Equipment Effectiveness (OEE),
Stripping Machine, Net Operating Time
1. Introduction
The pharmaceutical industry has an
important role in the effort of health
services to the community by producing
drugs that must meet the requirements of
efficacy, safety and quality [1]. The
pharmaceutical industry has benefited from
margins and low competition for decades.
Along with the development of the
pharmaceutical field and increasing
regulations to meet the aspects of efficacy,
safety and quality, regulations and
guidelines are always evolving, and
pharmaceutical companies are always
trying to meet these requirements [2]. In
addition to fulfill the current guidelines,
internally pharmaceutical companies are
also making performance improvements.
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Improving performance to achieve
operational efficiency and effectiveness in
terms of increasing the output of products
as a production department achievement
target to provide benefits for the company.
Previously, to increase the efficiency
of the production process, workers'
working time or adding new equipment and
machinery was carried out. Meanwhile,
currently it is known that improving
efficiency and operational effectiveness
should be done through optimizing engine
performance optimally to improve
equipment and engine reliability, improve
operator performance, minimize
turnaround times and reduce overall
downtime.
Machinery and equipment are one of
the supporting facilities for the production
process in the pharmaceutical industry to
carry out and perform its production
activities. In an effort to increase
productivity and machine output, it is
necessary to evaluate machine performance
regularly [4]. Evaluation that can be done is
to do an OEE (Overall Equipment
Effectiveness) analysis. OEE is a
comprehensive calculation method to
identify the level of productivity and
performance of machines or equipment
thereby efforts can be made to increase
effectiveness [5]. In determining OEE there
are three main measurement factors,
namely the value of availability,
performance, and quality [6].
The stripping machine plays the most
role in producing the finished drug product.
A stripping machine is a machine for
carrying out the primary packaging process
of tablets/caplets with packaging materials
from polycellonium. Stripping machine
performance was evaluated by calculating
the OEE value [7]. In optimizing the OEE
value of the stripping machine, one of the
most possible way is to reduce its line stops
in the production process. Line stop is a
factor that causes the stripping machine to
stop and not operate due to external factors
without producing a product [8]. With the
presence of a line stop in the process
primary packaging, it can reduce the value
of availability, performance and quality on
the stripping machine which in turn affects
the performance and OEE value. Therefore,
it is important to analyze and evaluate what
line stops occur and its affect the OEE value
of the stripping machine in the primary
packaging process. This study discusses
and identifies the total number of times the
line stop occurred and its effect the OEE
value of stripping machines in the primary
packaging process in one of the
pharmaceutical industries in Jakarta.
2. Methods
The research was carried out
through several stages of work, (1) Initial
observation, by observing the facilities of
the primary packaging area and following
the entire series of primary packaging
processes on the stripping machine for 1
month (2) Collecting the necessary data
such as the total operating time and time
loss on the stripping machine every day, the
number of products obtained in one day,
and the number of rejected products. Then
the identification and classification of line
stops found during the primary packaging
process takes place. (3) Data processing to
determine availability, performance,
quality and OEE values. Furthermore, an
analysis of the influence of the line stop on
the value of OEE on the stripping machine
was performed during the packaging
process so that improvement can be carried
out and optimized to be more efficient.
(a) Availability =
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[9]
(b) Performance rate =
[9]
(c) Quality rate =
[9]
OEE (%) = Availability (%) x
Performance Rate (%) x Quality Rate (%)
[9]
3. Result and Discussion
3.1 Line Stop
The stripping machine in the
primary packaging process at PT ABC
pharmaceutical industry is designed and
regulated at a speed of 2,160 caplets/minute
which is expected to produce 2,278,800
caplets in 1,440 minutes, of 3 shifts of 8
hours working time in a day. The expected
target for the stripping machine to continue
operating and produce products in 1 day is
1,055 minutes after reducing the
consideration of unplanned downtime.
Line stops are a factor that can cause losses
due to the low efficiency of the stripping
machine in the primary packaging process.
The poor productivity of the stripping
machine causes losses for the company or
production department because the number
of products obtained is low and does not
achieve the target.
During the research process and
data collection for one month, it was found
that the line stops due to several factors
such as were caplets stuck due to breaking
in the machine channel, brushing sealing,
workers' break time, changing of
polycellonium and many more. The total
line stops that occur are graphed by
showing the total time (minute) of
occurrence for 1 month in a primary
packaging process can be seen in Figure 1.
Figure 1. Pareto Line Stop of Stripping Machine Graphic
With the longer halt of the production
process due to stopped in stripping process, it will affect the number of products
produced. Line stops that appear on
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stripping machines make the machine not
operate and do not produce products
thereby the value of operating time of
stripping machines becomes reduced.
Reduced operating time of stripping
machines will degrade the availability,
performance and quality of the stripping
machine so that the OEE value will
decrease. The number of products (in
batches) produced by the presence of a line
stop in the primary packaging process can
be seen in Figure 2.
Figure 2. Output Of Stripping Machine (In Batch)
In the pharmaceutical industry loss of
machinery and equipment should be
avoided. These losses are known as the Six
Big Losses. Six Big Losses are 6 loss
factors that contribute greatly to the high
value of lost machine productivity thereby
reducing the work effectiveness of the
stripping machine [10]. The basis for
determining Six Big Losses determines the
results of OEE measurements [5]. Based on
the type of loss, Six Big Losses are divided
into 3 main categories, namely Downtime
losses, Speed losses, and Quality losses
which can be seen in Table 1.
Table 1. Type of Six Big Losses
Category
Type
Description
Downtime
Equipment failure/breakdown
Loss due to damage to the
machine/equipment or inoperation of the
machine
Set up and adjustment
Loss due to installation, tuning or
replacing of products on
machine/equipment
Speed Losses
Idling and minor stoppages
Loss due to machine/equipment stopping
on a short period of time
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Reduced Speed
Loss due to decreased production speed
in machinery/equipment
Defects
Process Defect
Loss due to defective products or
reprocessed products
Reduced Yield Losses
Loss at the beginning of production time
until it reaches a stable production time
[9]
3.2 Overall Equipment Efectiveness
(OEE)
OEE is a method used as a
measuring tool in the implementation of the
Total Productive Maintenance (TPM)
system to optimize machines and
equipment under ideal conditions resulting
high product being produced as output. The
TPM system ensures that all production
equipment and machine can operate in
proper conditions in order to avoid damage
and delays in the production process [2].
OEE is used as an analysis to monitor and
improve the efficiency of machines in the
production process. OEE value is the result
of multiplication of three main
measurement factors, namely availability,
performance and quality rate [9]. The three
measurement factors in OEE have their
respective sections listed on Table 2.
Table 2. OEE Study Parameters
Availability
Performance
Quality
Planned downtime
Speed losses
Production rejects
Breakdowns
Small stops
Rejects on start up
[3]
1. Availability
Availability describes the utilization of
available time for machine/equipment
operations. Availability is the ratio of
operation time by eliminating
machine/equipment downtime to loading
time [6]
2. Performance rate
Performance rate shows the ability of the
machine/equipment in producing products.
Performance rate is obtained by
multiplying the quantity of products
produced by the ideal cycle time against the
available time in the production process
(operation time). [3]
3. Quality rate
Quality rate represents the ability of the
machine/equipment in producing products
that are in accordance with the standard.
Quality rate is the ratio of the number of
products produced in good condition
produced compared to the total number of
units of products produced during the
production process [3]
The research was conducted by
measuring and calculating each of the OEE
parameter measurement factors which can
be seen in Table 3. The OEE value was
obtained by multiplying the three main
factors. The availability value of 85.05% is
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influenced by several things, such as
presence of line stops that cause the
machine to stop operating and loading time
is more than predict. The performance
value of 107.11% is obtained from
optimizing the machine stripping speed in
producing the product. Furthermore,
defective products produced are low so the
quality value obtained is 99.55%.
Table 3. Stripping Machine OEE Value
Stripping Machine OEE Value
Parameter
Classification
Output
Percentage
Availability (Minute)
Loading time
21,405
85.05%
Operating time
18,205
Performance (Pcs)
Target output
3,932,280
107.11%
Actual output
4,211,905
Quality (Pcs)
Actual output
4,211,905
99.55%
Good ouput
4,192,860
3.3 OEE Value Target Adjustment
The ideal production process is production
that results in zero failures in terms of
machine or equipment, zero defects and
rework as well as zero industrial accidents
[6]. OEE values range from 0 - 100%,
where 0% is inefficient, 100% is very
efficient and if the OEE value of 85% is
considered a benchmark for the production
capability is ideal. PT ABC pharmaceutical
industry targets the OEE value for stripping
machines on primary packaging process by
90%. This 90% OEE value is studied and
evaluated with consideration that is
adjusted to the machine conditions and
targets to be achieved [11]
Initially, the net operating time (total
machine operating time minus planned
downtime) previously amounted to 1,045
minutes for a whole one day with an
estimated line stop time of 395 minutes
thereby the number of products (strips)
based on the OEE value is shown in Table
4.
Table 4. OEE and Output of Stripping Machine Before Line Stop Adjustment
Shift
Net Operating
Time (minute)
Strip/minute
OEE
95%
90%
85%
80%
75%
1
395
216
81,054
76,788
72,522
68,256
63,990
2
295
216
60,534
57,348
54,162
50,976
47,790
3
355
216
72,846
69,012
65,178
61,344
57,510
TOTAL STRIP
214,434
203,148
191,862
180,576
169,290
205
TOTAL BATCH
2.68
2.54
2.40
2.26
2.12
The results show that the OEE of the
Stripping machine in February reached
90.7% with the details listed in Figure 3.
Based on the OEE value, it can be
determined the number of products
produced according to the calculations
made in Table 4. However, the OEE value
of stripping machines, especially
availability factors, still be able to be
improved and optimized by reducing the
line stop time that appears in the primary
packaging process. At the time of the
research, it was found that the line stops
which takes a long time and can be
minimized is the time for changing the
polycellonium. At the beginning, the OEE
calculation of the stripping machine used a
matrix calculation with a polycellonium
change time of 10 minutes according to
Table 4. However, the time that need to
changes the polycellonium on the stripping
machine must be standardized rationally.
Standard time is the time required for a
trained worker to complete a certain task,
work at a sustainable rate, and operate the
machine and equipment properly [12].
Figure 3. OEE Value of Stripping Machine
The results showed that the effective time
for changing the polycellonium was 5
minutes. Therefore, the reduction in
polycellonium changing time needs to be
changed from 10 minutes to 5 minutes. By
reducing the polycellonium change time to
5 minutes, the net operating time increases
so that the number of outputs in the form of
total strips and the number of batches also
increases. By reducing the line stop time,
the number of products produced can be
determined based on the OEE value
according to the new calculations made in
Table 5.
Shift
Net Operating
Time (minute)
Strip/minute
OEE
95%
90%
85%
80%
75%
1
425
216
87,210
82,620
78,030
73,440
68,850
2
325
216
66,690
63,180
59,670
56,160
52,650
3
385
216
79,002
74,844
70,686
66,528
62,370
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Table 5. OEE and Output of Stripping Machine After Line Stop Adjustment
The line stop effect has a big impact on the
OEE value and the number of products
produced. Changes in line stop time in the
form of changing polycellonium from 10
minutes to 5 minutes on the stripping
machine increase the net operating time by
8% and this can increase the OEE value
approximately by 5%. With the increasing
net operating time, it is expected that the
availability of stripping machines that can
operate longer is present and produce more
products so that can optimize stripping
machine performance and OEE targets are
also achieved.
4. Conclusion
Based on the study, OEE is an
effective method for optimizing the
production process in the pharmaceutical
industry by evaluating machine
performance. The result showed that
reducing the changing of polycellonium
time from 10 minutes to 5 minutes as one of
the line stops on the stripping machine
during the primary packaging process
increase the net operating time by 8% and
increase the OEE value by 5%.
Acknowledgement
The authors would like to show gratitude
and thank you to PT ABC, Jakarta -
Indonesia, for providing data and
information for the purpose of this research.
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