This presentation is basic knowledge about the critical Hazard management system and how to manage hazard in pharmaceutical industry , key elements of hazard management system , risk assessment and types of explosions .
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
Air Based Hazards, M.pharm, sem 2,Bhumi Suratiya,.pptxBhumiSuratiya
Air Based Hazard, M.Pharm, Sem 2,Bhumi Suratiya, Pharmaceutical Quality Assurance. Source of air based hazard, types of air based hazard, air circulation maintenance for sterile and non sterile area . Application of air circulation, HEPA filter, clean area classification.
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
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Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
This presentation describes outlines and discusses the regulations
applicable to the QA function and unit, structure, function and
application of the unit in the pharmaceutical manufacturing
environment. In addition, it discusses additional quality – related
responsibilities that may result when manufactures move toward a
quality system approach to quality that incorporates current quality
system models to further improve quality and harmonize with inter-
national quality requirements.
CONTENTS
1. General areas interest in the building:
Walls and celling's
Floors and drains
Doors ,windows and fittings
Equipment
Pipelines
2. RAW MATERIALS
3. WATER
Microbiological results
Essential document
PQ is divided into 3 phases
Microbiological procedure reviewed
4. PACKAGING MATERIALS
Air Based Hazards, M.pharm, sem 2,Bhumi Suratiya,.pptxBhumiSuratiya
Air Based Hazard, M.Pharm, Sem 2,Bhumi Suratiya, Pharmaceutical Quality Assurance. Source of air based hazard, types of air based hazard, air circulation maintenance for sterile and non sterile area . Application of air circulation, HEPA filter, clean area classification.
Advance non – sterile solid product manufacturing technologyAbhishekJadhav189260
The pharmaceutical manufacturing process is typically made up of a
combination of specific unit processes chosen according to physical
and chemical characteristics of active pharmaceutical ingredients.
Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Like manufacturers in all industries, pharmaceutical manufacturers and their employees face real and serious health and safety issues. In some cases, the hazards are the same ones we find in most manufacturing facilities. In other cases, the hazards are more specific to pharmaceutical manufacturing. Likewise, pharmaceutical manufacturers use hazard controls and risk mitigations that are common to many industries as well as more specific to pharmaceutical manufacturing, including all levels of the hierarchy of controls, from elimination down to administrative controls such as training for pharmaceutical safety and the use of PPE.
The presentation is about hazard identification as against hazard assessment. The need to comply with all standard safety procedures as outlined by OSHA
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Critical Hazard Management System & Explosions.pptx
1. Prepared by : Mansi Vadodariya
Enrollment No. 222280824015
M.Pharm
Semester II
DEPAETMENT OF PHARMACEUTICAL QUALITY ASSURANCE
L.M. COLLEGE OF PHARMACY
3. Introduction
3
• HAZARDS means an activity, arrangement, circumstances, event, process,
situation and substance (whether arising or caused within or outside a place of
work) that is actual or potential cause or source of harm.
• HAZARDS MANAGEMENT is a essential problem- solving process (to identify
hazards), gather information about them (assessing the risks) and solving them
(controlling the hazards).
4. Some of the most common health risks associated with workplace hazards -
4
Reduced wellbeing
Disasters and
conflicts
Hearing damage Breathing problems
Damage to muscles,
bones and joints
Skin Irritation
5. TYPES OF HAZARDS
Physical hazards- it includes vibration, noise,
slips, trips and falls.
Chemical hazards- any hazardous substances
it can causes the harm to employees health.
Biological hazards- bacteria and viruses that
cause health effects, such as hepatitis, AIDS
and legionnaire’s disease.
Ergonomic hazards- physical factors that
harms the musculoskeletal system, such as
repetitive movement, manual handling and
poor body positioning.
5
6. Key Elements of Hazard Management
System
Identification of all hazards
Determining whether the hazard can be eliminated or isolated
Assessing the remaining hazards to determine whether they are principal hazards
or significant hazards appliances and equipment.
Developing and introducing Principal Hazard Management Plans (PHMPs) for
principal hazards.
Developing and introducing Principal Control Plans (PCPs) for all principal control
mechanisms.
6
7. For remaining hazards, where they cannot be eliminated or isolated, conducting
a risk assessment to minimize the likelihood of the hazard to workers by setting
controls. This should include Standard Operating Procedures (SOPs) and/or
Trigger Action Plans (TARPs) where applicable.
Participation of workers in the identification, assessment and control of
hazards.
7
9. 1. IDENTIFICATION OF HAZARDS
This is the fundamental step in hazard management. Some ways of identifying
hazards:
• Workplace inspection
• Incident reporting
• Register of injuries
• Consultation with employees
• Feedback from employees.
9
10. 2. RISK ASSESMENT
• When you have identified the hazards, you
need to assess the risk created by each
hazard.
• The risk is the likelihood that the hazard will
cause injury, illness or disease in the way
that it is used or occurs in the workplace,
and the severity of the injury
• illness or disease that may result
10
12. 3. HAZARD CONTROL
• When selecting controls you first need
to look for controls that will prevent the
incident occurring (preventive). Any
controls that minimize the
consequences of the incidents are only
supplementary to prevention.
• It is not enough to just find and rate the
hazards. After founding the hazard it is
important to eliminate or control the
hazard before the injury or illness of
people due to hazard.
12
13. 4.EVALUATE , MONITOR & REVIEW
• It is important to know if your risk
assessment was complete and accurate.
• It is also essential to be sure that changes
in the workplace have not introduced new
hazards or changed hazards that were
once ranked as lower priority to a higher
priority.
13
14. KEEP RECORDS
• Keeping records of your assessment and any control actions taken is very
important. You may be required to store assessments for a specific number of
years.
• Check for local requirements in your jurisdiction. The level of documentation or
record keeping will depend on:
Level of risk involved.
Legislated requirements.
Requirements of any management systems that may be in place.
Your records should show that you:
• Conducted a good hazard review.
• Determined the risks of those hazards.
• Implemented control measures suitable for the risk.
• Reviewed and monitored all hazards in the workplace.
Presentation
title
14
15. EXPLOSION
• An explosion is the rapid increase in volume and release of energy in an
extreme manner, usually with the generation of high temperatures and the
release of gases There are three fundamental types :
1. Mechanical
2. Nuclear
3. Chemical
• A mechanical explosive is one that depends on a physical reaction, such as
overloading a container with compressed air.
• A nuclear explosive is one in which a sustained nuclear reaction can be made
to take place with almost instant rapidity, releasing large amounts of energy.
• A chemical explosive is a compound or mixture which, upon the application of
heat or shock, decomposes or rearranges with extreme rapidity, yielding much
15
16. Mechanical Explosion
• Strictly a physical process, as opposed to chemical or nuclear, e.g., the bursting
of a sealed or partially sealed container under internal pressure is often
referred to as an explosion. Examples include an overheated boiler or a simple
tin can of beans tossed into a fire.
16
17. Chemical Explosion
• A chemical explosive is a compound or mixture which, upon the application of
heat or shock, decomposes or rearranges with extreme rapidity, yielding much
gas and heat.
• For chemical to be explosive, it must exhibit all of the following:
1. Rapid expansion ( rapid production of gases and rapid heating of surrounding)
2. Evolution of heat
3. Rapidity of reaction
4. Initiation of reaction
• Chemical: Chemical explosions occur due to either decomposition or
combination reactions, which are both exothermic reactions. Consequently, the
rapid expansion of gas which is released forms a shock wave.
• There are two types of chemical explosives: High-Order Explosives and Low-
Order Explosives.
17
18. Types of chemical explosives Basically, chemical explosives are of two types:
(1) detonating, or high, explosives
(2) deflagrating, or low, explosives.
Detonating explosives, such as TNT and dynamite, are characterized by
extremely rapid decomposition and development of high pressure
Detonating explosives are usually subdivided into two categories, primary and
secondary :
Primary explosives detonate by ignition from some source such as flame, spark,
impact, or other means that will produce heat of sufficient magnitude. .
Secondary explosives require a detonator and, in some cases, a supplementary
booster.
Deflagrating explosives, such as black and smokeless powders, involve merely
fast burning and produce relatively low pressures. prevent the formation of an
explosive atmosphere, including by ventilation. collect, contain and remove any
releases to a safe place, avoid ignition sources, avoid adverse conditions (such
as exceeding pressure/temperature limits) that could lead to danger.
18
19. Multiphase Reactions
• Multiphase reactions refer to reactions involving components in different
phases, and is combination of simultaneous phase change and conversion of
some materials to others Classification on no. of phases.
19
Gas-liquid
solid
catalytic
20. • Multiphase reactions are very common in the pharmaceutical industry and
include, e-g., hydrogenations, oxidations, halogenations and phase-transfer
catalysis reactions.
• They involve combination of two or more immiscible phases (e.g., liquid-liquid,
solid-liquid or gas-liquid reactions).
• When mass transfer from one phase to the other is the rate-determining step :,
crucial to maximize the interfacial area.
• In batch, the interfacial area is low and poorly defines, thus, leading to
prolonged reaction times.
• Due to the small characteristic dimensions of micro reactors, large and well
defined interfacial areas are observed, typically orders of magnitudes higher
than traditional batch environments.
• These large interfacial areas lead to efficient transfer between the two phases.
20
21. • Continuous flow (micro) reactor technology therefore offers the unique
possibility perform multiphase reactions, in particular gas-liquid chemistry, with
unparallel efficiency and process safety.
• Gases can be dosed into the flow system with precise, stoichiometry using mass
flow controllers and intense mixing of the gaseous and liquid phase can be
achieved.
21
22. Some Examples of Multiphase Catalytic Processes:
• Hydrogenation of specialty chemicals
• Oxidation of glucose to gluconic acid
• Oxidation of n-paraffins to alcohols
• Methanol synthesis
• Fischer-Tropsch (FT) synthesis
• Hydrodesulfurization (HDS) of heavy residuals
• Adiponitrile synthesis
• Production of animal cells
• Fermentation processes
22
23. Other Emerging Multiphase Catalytic Technologies -
• Catalysis by water soluble metal complexes in biphasic and non-ionic liquid
media
• Reactions in supercritical fluid media
• Asymmetric catalysis for chiral drugs/agrichemicals
• Polymerization with precipitating products (e.g., Polyketones)
• Phase transfer catalysis
• Catalysis by adhesion of metal particles to liquid-liquid interfaces
• Catalysis by nano-particles and encapsulation of metal complexes
23
24. REFERENCES
24
1. https://www.osha.gov/safety-management (OSHA guidelines )
2. Work place safety and health act (chapter 354A, section 65) work place safety and
health (risk management) regulations.
3. Wai Onn Hong, Tips For Hazard Identification, Risk Assessment, Risk Control ,
publisher Bookrix in 2015 ; 23 march 2020.
4. Depanti gajjar, Sanjay A. Nagdev, et. Al; “ A text book of Hazards and safety
Management”; S. Vikas and company publication; 2021; pg no. 81-88.