CHAPTER VI

RESULTS AND DISCUSSIONS

To find out the actual requirement of HIRA in Biocon API production

units, in which they handle more quantity of flammable chemicals & powdered
materials. This study was carried out by considering the facilities at Biocon park,
Bangalore.
Below mentioned incidents are happened in last 45 days. There may be types of
incidents that may occur frequently, but would cause very little damage and there
may be other types that may cause general damage, but would have a very low
probability of occurrence. Both are important need to be considered.
There are totally 90 number of employees in the plant. Out of 90 employees, 75
employees are working in the process area and the remaining 15 employees are
working in the office work area (documentation).
By visiting the plant, 45 days observed the various stage employee activities.
Walking around the office area to inspect the process area. Various stages and the
various material handling are noted. To study, Standard Operating Procedure
(SOP) after to interacted with employees to list out their difficulties. Looking at
literature review, the study of HIRA to perform in various process industries. A
HIRA study is a formal systematic procedure used to review the existing control
measures and operation of a potentially hazardous process facility. It is used to
identify deviations from normal safe operation, which could lead, to hazards (or)
unsafe condition, potential failure modes and to define any actions necessary to
deal with these. To obtain process in the various stages were analysed and
identified the hazards. The discussion was conducted with the Environmental
Health and safety (EHS) team to recommended possible control measures.

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 Type of employee involved (Last 45 Days
= Male only)
Total number of employees = 75
Age limit 21-
26 (12 Age limit 27-
Age limit 21-26 (12
Employees) 33 (3
Employees)
16% Employees)
4% Age limit 27-33 (3
Employees)
Age limit 34 - Age limit 34 -40 (1
40 (1 Employee)
Age limit Employee)
40 Age limit 40 above
3%
above (No one)
(No one)
77%
Figure 6.1. Pie chart of type of employee involved

Type of Root cause

Personal
behaviour
Material 30%
45% Personal behaviour
Environment
Environment
Material
25%

Figure 6.2. Pie Chart of type of root cause involved

Condition of the job of the total employees are regular.

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 Table 6.1 Hazard Identification and Risk Assessment in API of Pharmaceutical Industry

Equipment/ Hazards OHS Risk Condition Assessing Existing controls Additional Assessing Risk
RPN with RPN with level
S.NO Location of the job Existing Controls additional
controls controls
Engg. Admin. PPE
P S R
P S R
Stainless steel Dust Respiratory Scrubber & Organic Powdered air
1 reactor exposure, problems R 4 3 12 Ventilation SOP vapor purifying 2 1 2 Low
vapors, and burns system mask respirator
fumes
Stainless steel Dust Respiratory Scrubber & Organic Powdered air
2 vessel exposure, problems R 4 3 12 Ventilation SOP vapor purifying 2 1 2 Low
vapors, and burns system mask respirator
fumes
Rotocone Dust Respiratory Scrubber & Organic Powdered air
3 vacuum drier exposure problems R 3 3 9 Ventilation SOP vapor purifying 2 1 2 Low
and burns system mask respirator
Basket Dust Respiratory Scrubber, Organic Powdered air
4 centrifuge exposure, problems, R 4 3 12 Blower & SOP vapor purifying 2 2 4 Low
vapors, Eye Ventilation mask respirator
fumes irritation system
and burns

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 Figure 6.3. Risk Evolution Matrix for HIRA

By assessing the HIRA method, the above table shows the findings of hazard and
risk assessment in API of pharmaceutical industry. From these able to identify the
potential hazard in API, the findings of the potential hazard of a risk by assessing
the RPN value with existing controls value ranges from 9 to 12, it is considered
that the level of risk is medium. By chance of implementation of additional control
measures of Powdered Air Purifying Respirator that the additional controls value
ranges from 2 to 4, it is considered that the level of risk is low.

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6.1 HIERARCHY OF CONTROLS
Elimination
The elimination of the equipment is not suitable for the process. Without
this equipment the process cannot able to proceed furtherly.
Substitution
The substitution of alternative equipment (or) process procedure are also
not suitable for that process.
Engineering controls
Engineering controls are to eliminate (or) minimize the hazards. By the way
of isolating the hazard by means of implemented the scrubber, ventilation and
blower system and all other possible control measures.
Administrative controls
Document of Standard Operating Procedures (SOP), Work permit and safe
work practices are all available to reduce the potential hazards, noise, stress and
ergonomic hazards.
Personal protective equipment
Personal Protective Equipment (PPE) and it creates a barrier against
workplace hazards. PPE is acceptable as a control method in following when
engineering controls are don’t eliminate the hazards. By the way of PPE,
implementing the Powdered Air Purifying Respirator (PAPR) the hazard is
eliminated.
Powdered Air Purifying Respirator (PAPR) can be used to protect against gases,
vapors and particles. It is a type of respirator used to safeguard workers against the
contaminated air. PAPRs consist of a headgear and fan assembly that takes
ambient air contaminated with the pollutant actively removes with the help of
various filters and then delivers the clean air to the user’s face or mouth and nose.
The full face shield provides the eye protection.

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Figure 6.4. Powdered Air Purifying Respirator

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