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HAZOP STUDY FOR THE PROCESS INDUSTRY FOR IDENTIFYING THE


HAZARD AND ITS VARIOUS CONTROLS
A. Yudhistra kumar*1
*1Head Environment, Health and Safety department, EHS Head @ Lake Chemcials pvt ltd,
Bangalore, India.
ABSTRACT
For studying the Hazard in the process industry, Hazard and operability (HAZOP) methodology is one of
the Process Hazard Analysis (PHA) technique has been used worldwide to identity the hazard and its
control in the process industry, it not only emphasis on the existing hazards but also its operability and its
control. The Batch management record (BMR) plays a vital role in identifying the critical hazard involved
during each activity and its control measures. The HAZOP study uses different parameters and guide
words during the activity, which has been carried out during the process. The study has been carried with
the discussion with the internal teams for each of the identified critical activity and the hazard associated
to it, various existing controls and the recommended controls to be implemented in order to avoid the
hazard while performing the activity in the process.
Key words: HAZOP, PHA, Process industry, BMR, Internal teams.
I. INTRODUCTION
The pharmaceutical and the other hubs, which are related to the drug discovery play an important role in
the innovations of the new drugs in the market. There are many new hazardous and risky procedures,
which are involved in the production activities. The procedures involved in the drug invocation, its
practical implementation from the lab to pilot to the large scale, which is in the form of the reactors,
Centrifuges, dryers, Jet milling and multi milling and blending of the material. There is a great and
growing awareness of the necessity for applying more scientific and systematic approaches in handling
the raw materials, which includes powder and liquid chemicals and solvents, where it involves loading
and unloading of the chemicals, which are used in the process. Also, in this scenario the senior operators
in the organization should check the mechanical integrity of the equipment’s and instruments before
starting of any of the process activity in the plant. Proper human assessment is done for the process
before the starting of the new product in the intermediate and finished goods block. A PHA is a careful
deliberate and methodical methodology for recognizing, assessing, and controlling the risk in the
activities in each stage of the production process. A procedure of the risk assessment for the execution of
the activities in the production block has been carried out by recognizing, assessing, and controlling the
dangers associated with the critical activities. The critical activities were chosen from the Batch
management record (BMR) and it has been assessed for the risk involved in the various activities and
their necessary controls to be adopted for controlling the risk and the hazard. In this regard all the team
from the different department were involved in identifying the critical risk in the process with the help of
the various departments such as R&D, Production, stores and Mechanical department were involved in
identifying the critical Hazard in the process. The group comprising of four to five people who have an
adequate knowledge on the process and its chemical used in the process, for which the consequences and
the controls applied the process has been documented to avoid the danger during the operations and
handling of the chemicals in the pharma industry
The HAZOP Study is considered as a process study conducted to avoid the danger [1], Hazard
Identification (HAZID) is a Quantitative hazard analysis. HAZOP is more proper than Energy Trace and
Barrier Analysis (ETBA) to foresee and distinguish dangers yet applying ETBA is less demanding than
HAZOP [2]. The way toward utilizing HAZOP is contributing fundamentally to the improvement of the
organization working procedures and better maintainable condition and avoiding the risk during the
operations by adopting the various controls [3]. Although the major part of the HAZOP investigation is
done for the process identification of the critical hazard and various ways of mitigating the hazard. There
is, scientific approach being developed for the need of an hour for conducting the HAZOP. The
investigation of these dangers, which focuses on the process hazards, human mistakes and errors during
the operations. Major experts use the HAZOP study in order to avoid the accidents during the execution of
the process in the industry [4]. With regularly expanding of scientific methodologies used for mitigating
the risk during the executing of the process [5]. The dangers, in the process has been avoided by following

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the HAZOP guideline, which an appropriate and scientific qualitative analyse has been used around the
globe [ 6]. In other words, HAZOP is an organized and precise examination of existing procedure of an
activity in the production, which has been distinguish and assessed on the issues that may relate to
dangers associated in the facility or in the process., or anticipated risk in the production activity [7]. The
HAZOP strategy was at first used for the operations involving the synthetic process frameworks, then the
frame work of the HAZOP later used to different operations in various sectors, which is very well
recognized [8]. During the critical HAZOP the various guide lines being used to assess the danger in the
process.
There might be a few deviations with possible causes and having conceivably perilous outcomes, it all
depends on the management of safety in the organisation, the way in which the safety budget is allocated
and the various control instruments has been implemented and the people are regularly trained in
handling the various liquid and solid chemicals in the reaction process to avoid the hazard in the process,
for example people are trained in using the scrubber to avoid the acid fumes in the reaction mass and
frequently observing the ph concentration in the scrubber tank and see that the fumes, which are let out
from the scrubber should be neutral. The preventive program is extremely powerful in distinguishing and
controlling these sorts of hazard [9]. Checking all the procedure, which guarantee every conceivable
critical deviation from the manner in which risky circumstance that is evident and the controls to be
adopted. The study of the critical process of the HAZOP has been conducted for the BPN product.
II. HAZOP METHODOLOGY USED IN THE PROCESS
Tabel.1: Guide word and its meaning for the HAZOP study

Tabel.2: Various Deviations and guide words, which can be used during the HAZOP

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III. RESULTS AND DISCUSSION
From the mid-1970s, the HAZOP methodology has been widely employed in the process industry as a
reliable tool for risk assessment by using the various guide words and its deviations, thus resulting in the
avoiding the risk and the hazard during the handling of the chemicals and their operations. There there
are large number of publishing papers in the different case studies with this methodology have been used.
Swann and Preston [10] described the historical evolution of the HAZOP methodology, in their work,
which is presented the use of this methodology since the late 1960’s until 1995, being the first paper
making this type of research. However, it was not the only work mentioning the historical evolution of
publications referring to the HAZOP methodology. As a second example, Marhavilas et al. [11] conducted
a research on risk analysis and assessment methodologies during a decade, starting in early 2000 until
the end of 2009. Finally, Dunjó et al. [12] conducted one of the most intensive research of publications
where the HAZOP methodology was applied within the process industry since it was conceived (the
1960’s) until early 2009. At the end of 2016, an idea of carrying out a review of publications of the
HAZOP methodology in the last ten years was conceived, aiming to establish its state-of-the-art and
perspectives within the process industry. For this reason, the period considered in this work included the
decade between 2005 and 2015. In this present scenario there are critical hazard involved in the process
industries especially in pharma industry is very less in India, which is documented and published, So an
attempt has been made for the critical HAZOP for the BPN product, which consist of may stages during
the manufacturing of the Intermediate to Finished goods
Table.3: HAZOP for the critical hazard (Deviation), cause, Consequences and its control/action
required

Activity of Guide word and its Cause Consequence Action Required


operation Deviation

More N2 in the 1.Human error 1.Reactor may 1.Vent of reactor


reactor 2.Malfunction of pressurize. should be open
N2 line valve. 2.N2 wastage 2.The Valve
3.Pressure gauge 3.Will not affect to functioning to be
malfunction process. ensured
3. Pressure gauge
N2 calibration
replacement
in the reactors Less N2 in the reactor 1.No N2 cylinder Moisture present 1.N2 cylinders
2.Human error in reactor will availability to be
cause violent ensured
3.Malfunction of
reaction with 2.Valve
N2 line valve.
NaBH4 functioning to be
ensured

More Quantity 1, Human error 1.Undesired 1.Labeling of


while dispensing reaction may Quantity of
2.Weighing error occur. material at stores.
2.Difficulty in 2.Ensure the
handling. calibration of
3.More quantity weighing balance.
of reagent
required for
Charging of quenching of
excess sodium

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Sodium borohydride.
Borohydride 4.More flammable
gases may be
produced during
quenching.
5. Cost will
increase.

Less Quantity 1.Human error 1.Incomplete 1.Labeling of


while dispensing. reaction quantity.
2.Weighing error. 2.Yield will be 2.Ensure
3. Charging less calibration of
weighing
machine.

No sodium Human error No Reaction 1.Proper


Borohydride. supervision
2. Stores
department to
maintain
sufficient quantity

Other than sodium 1. Dispensing Depends on the 1.Labeling of


Borohydride. error. other chemical material at stores.
2.Human error. but not 2.Usage of
recommended, dedicated drum
3.Labeling error.
negative effect on for storage of
the reaction. NaBH4 at
production block
to avoid contact
with the water &
Moisture content.
3.Trained people
should handle the
reaction

As well as sodium 1.Dispensing Depends on the 1.Labeling of


Borohydride. error. other chemical material at stores.
2.Human error. but not desirable. 2.Usage of
3.Labeling error. dedicated drum
for storage of
NaBH4 at
production block
to avoid contact
with the water &
Moisture content.
3.Trained people
should handle the
reaction

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Reverse Not possible Insignificant -


No PPE used 1.Non availability It may result in 1.Proper training
of the PPE in dizziness, to be given for the
safety headache, lack of operators for the
department coordination, usage of the PPE
2.Safety nausea, salivation 2. Sufficient
precautions not and loss of quantity of PPE to
been taken before appetite. be kept with the
starting the Safety
activity department

More Quantity of Human error Will not affect the 1.Dip


pyridine while dispensing ongoing reaction. measurement at
using dip rod. stores and at
production block
to be checked.
2.Ensure
calibration of dip
rod.

Less quantity of Human error 1.Reaction Dip measurement


pyridine while dispensing progress will be at stores and at
using dip rod. affected. production block
Charging of
2.Reaction mass and the
Pyridine from
may become calibration of the
drum to the
thick. rod to be checked
reactor by
using vacuum No pyridine 1. Failing to 1.Wastage of 1. sufficient stock
charge Pyridine. Pyridine. to be maintained
2. Vacuum failure 2.Cannot proceed at the stores
3. Bottom valve to next step. department
kept open. 2. Fixing of
dummy to the
bottom valve and
ensuring the
closing of bottom
valve.

Other than pyridine 1.Incorrect Depends on the 1.Labelling of


labelling other chemical material at stores.
2. Human error. but not 2.Usage of
recommended dedicated pipes
3. Leakage in
condenser or for charging of
jacket Pyridine & dry
the pipe with N2
before charging of
Pyridine.
3. Checking the
solvent before
charging into the

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reactor.
As well as pyridine Incorrect Depends on the 1.Labelling of
labelling and other chemical material at stores.
human error. but not desirable. 2.Usage of
dedicated pipes
for charging of
Pyridine & dry
the pipe with N2
before charging of
Pyridine.
3. Checking the
solvent before
charging into the
reactor.

More Quantity of 1.Human error. Reaction will go 1.Operator


Socl2 2.Error in into completion, control. 2.While
calibration of But the effluent adding thionyl
weighing balance. load may increase chloride fumes
due to presence of will come, so that
excess thionyl proper PPE
chloride. should be used by
the operator
while involving in
the activity

Less quantity of 1.Human error Reaction may not 1.Operator should


Socl2 2.Error in go into read the BMR
calibration of completion. before starting
weighing balance. the activity
2. Operators
should be trained
to perform the
activity
Addition of
Thionyl Slow addition of No Impact Reaction may go 1.Checking the
chloride Socl2 for completion. addition valves
before starting
2. Proper
supervision.

Fast addition of Socl2 Human error. Reaction may lead 1.Checking the
Addition valve to exothermicity addition valves
failure. before starting
the activity
2. Trained people
should perform
the task
No PPE used while 1. No Training 1.Irritate the nose 1. Training for
performing the and 2. Non and throat handling of the

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activity availability or 2.Shortness of thionyl chloride
PPE breathing to be provide for
the usage of the
PPE.
2. Sufficient stock
of PPE to be kept
in the safety
department

No thionyl chloride Human error Reaction will not Stock to be


move further. maintained in
stores
department

Other than thionyl 1.Dispensing Reaction will not Depends on the


chloride error. go into chemical / off
2.Human error. completion. spec product
charged.
3.Labelling error

As well as thionyl 1.Dispensing 1.Depends on the 1.Sampling and


chloride. error. other chemical quality check at
2.Human error. but not desirable. stores.
3.Labelling error. 2, Negative 2.Labelling of
reaction may take material at stores.
place Checking with in
house batch
number at
production block.

Stirrer stopped 1.Electrical failure 1.Improper 1.DG set to be


2.Mechanical mixing leads to switched on when
failure ineffective power goes off
reaction 2.Proper
3.Manual failure
2.Sudden supervision
exotherm may 3.preventive
result after maintenance of
starting the motor &
stirring mechanical parts
as per preventive
maintenance
schedule
Scrubber 1.Improper 1, Environmental 1.Proper
breakdown/Improper maintenance of pollution supervision
scrubbing of thionyl scrubber 2.Health effects before starting
chloride fumes/odour 2.Caustic the batch
unavailability 2.Periodical
3.Power failure changes of
scrubbing media

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3.Ph of 14 is
maintained the
scrubber tank and
recirculation is
properly
happening
Heating to 40- More than 60°C 1. Usage of steam 1.Reaction may go 1.Heating should
60°C after for heating to 40- for the be given by hot
charging the 60°C. completion. water.
Socl2 2.Human error. 2.Undesired 2.Operator
3.Steam valve reaction control.
throttling failure conditions. 3.Pneumatically
to the hot water operated solenoid
tank. valve in steam
3.Malfunctioning line
of temperature for temperature
indicator control.
3.Ensure the
Calibration of
temperature
controller.

Less than 40°C 1.Insufficient Reaction may not 1.Heating should


steam pressure move further be given by hot
and throttling. water.
2.Malfunctioning 2.Ensure the
of temperature Calibration of
controller. temperature
3.Steam trap gauge
failure to eject the 3. Stream trap to
condensate. be cleaned and
see that the
condensed water
is let out properly

Cooling more than 1.Human error. 1, Undesired 1. Proper


5°C 2. Malfunctioning condition. supervision.
of temperature 2.Product may 2.Calibration of
controller isolate. temperature
controller.

Less cooling 1, Human error. Negative reaction 1.Proper


2. Temperature supervision.
controller not 2.Calibration of
functioning temperature
controller.

More time 1.Human error in Increase in cycle 1. Proper


Cooling to 0- recording and time and utility. supervision.
5°C maintaining the 2. Training to be

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temperature. provided for
2. Availability of following the
less utility. BMR
3.Not following
the BMR

Less time Human error in Decrease in cycle Proper


recording time supervision.
2. Not following
the BMR
Spin dry for more 1, Not following No effect on next 1.Proper
Loading into than 30 minutes the BMR step. supervision
centrifuge and 2.Human error 2.Operator
spin dry for 30 control.
mins and
Spin dry for less than Human error ML's left over in 1.Proper
unloading
30 minutes. the material supervision
might affect the 2.Operator
next step control.
reaction.
3.Training for the
operators

More weight 1.Human error in More yield than Calibration of


weighing given in BMR, it weighing balance.
2.Incomplete will deviate.
Unload the
material and activity
record the Less weight 1.Human Error. Trial or validation Periodical
weight. may fail if the Calibration of
2.Yield recorded
in the BMR will be yield is not in the weighing balance
less. range

More temperature 1.High steam 1.No effect on 1. Operator


pressure to hot product quality control.
water tank and and yield upto 2.Checking of
Steam throttling 40°C.More than steam control
valve failure to 40°C product may valve at regular
Drying the the hot water degrade. intervals.
compound for tank.
3.Calibration of
8 hrs in 2.Malfunctioning temperature
RCVD@ 25- of temperature sensors.
30°C controller.
Less temperature 1.Insufficient It will take more 1.Operator
steam pressure to time for drying control.
hot water tank. the compound. 2. Pneumatically
2.Steam throttling operated solenoid
valve failure to valve in steam
hot water tank. line
3.Malfunctioning for temperature

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of temperature controller to be
controller. checked
3. Calibration of
the temperature
gauge

No Heating Human error No drying Proper


supervision.

More time 1.Human error in No effect to the 1. Proper


recording product purity Supervision
maintenance and yield up to 3.Operator
time. 14hrs. control.
2.Less vacuum. 4.Training to be
3.Low given to the
temperature. operators

Less time Human error in Loss of Drying 1.Proper


recording (LOD) May not Supervision
maintenance meet the 2.Operator
time. specification control.
limit.

Less vacuum 1. Human error. Prolonged drying Proper


2.vacuum pump might affect the supervision
and line valve product quality
failure.
3.Trap may fill
with solvent.
vacuum guage
failure
The application of Hazor methodology in industrial processes has not changed its procedure significantly
over the years because most of the HAZOP methodology applications aimed to assess risks in critical
systems or when is needed to analyse systems looking for a continuous improvement, which are
discussed and recorded in the form of the tabular form as said above. Many of the authors like Hashemi-
Tilehnoee et al. [13] identified deviations and their proposed measures to reduce risks in a reactor
cooling following the traditional methodology procedure. In a similar case. Many of the other authors
such as Jose et al. [14] applied the methodology and identified deviations and possible effects during the
operational staff performance in an electrical discharge machining process. The study of the HAZOP has
been used in the different process in different sectors such as Mohammadfam et al.[15] presented
another case where the study in a fatty acid unit of an oil company allowed assessing environmental
health and safety hazards. As a result of their work, authors established a fast and efficiently procedure to
identify deviations and promote the implementation of mitigation measures is a continues process for an
improvement in the process industry
IV. CONCLUSION
The HAZOP methodology is one of the most PHA tools used by specialists in risk management. As it is
seen in this paper, it will continue to be followed in the process industry for avoiding the deviations and
applying the various controls while running the batch process in the pharmaceutical industry, this is an
attempt made for a single product produced in the industry to avoid the critical risk during the operation.
However, to address new challenges within the current process in an industry depends on the viability of

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the technology used and the methodology of improving the process by implementing the various advance
control in the process, which will help the process industry to be well equipped with the advance system
in safety control.
V. REFERENCE
[1] IEC 61882:2001 Hazard and operability studies (HAZOP studies). Application guide.
[2] Shirazeh Arghami, Sedigheh Abbasi, Shakiba Bakhtom ,Mansour Ziaei 2014 “Comparing of HAZOP
and ETBA Techniques in Safety Risk Assessment at Gasoline Refinery Industry” by African Journal
of Basic & Applied Sciences 6 (1): 01-05, 2014. 17.
[3] Siddiquia N.A., Abhishek Nandana, Madhuben Sharmaa and Abhinav Srivastavaa, , “Risk
Management Techniques HAZOP & HAZID Study” International Journal On Occupational Health &
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[4] Dennis P, Nolan PE. Application of HAZOP and What-If Safety Reviews to the Petroleum,
Petrochemical and Chemical Industries. 1st ed. Noyes Publications. USA, 1994: pp. 67-84.
[5] Khan FI, Abbasi SA. Major accidents in process industries and an analysis of causes and
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[6] Johnson RW. Beyond-compliance uses of HAZOP/LOPA studies. J Loss Prev Process Ind 2010; 23
(6): 727-733.
[7] Rossing NL, Lind M, Jensen N, Jorgensen S. A Goal Based HAZOP Assistant Original. COMP AID CH
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[8] Kitajima T, Fuchino T, Shimada Y, Naka Y, Yuanjin L, Iuchi K, Kawamura K. A New Scheme for
Management-of-Change Support Based on HAZOP Log. COMP AID CH 2010; 28: 163- 168.
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[11] Swann CD, Preston ML. Twenty-five years of HAZOPs. Loss Preven Proc. 1995;8(6):349-53.
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[13] Dunjó J, Fthenakis V, Vílchez JA, Arnaldos J. Hazard and operability (HAZOP) analysis: a literature
review. J Hazard Mater. 2010;173(1-3):19-32.
[14] Hashemi-Tilehnoee M, Pazirandeh A, Tashakor S. HAZOP-study on heavy water research reactor
primary cooling system. Ann Nucl Energy. 2010;37(3):428-33.
[15] Jose M, Sivapirakasam SP, Surianarayanan M. Analysis of aerosol emission and hazard evaluation of
electrical discharge machining (EDM) process. Ind Health. 2010;48(4):478-86.
[16] Mohammadfam I, Sajedi A, Mahmoudi S, Mohammadfam F. Application of hazard and operability
study (HAZOP) in evaluation of health, safety and environmental (HSE) hazards. Int J Occup Hyg.
2012;4(2):69-72

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