2 sources of hazards in pharma manufacturing and formulation installations. handling and storage of...
TRANSCRIPT
![Page 1: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/1.jpg)
Introduction to key environmental aspects of pharmaceutical industry in India
Faculty :- Mr Shridhar Rajpurohit – LA (IMS )/ TUTOR /SAFETY
![Page 2: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/2.jpg)
2
SOURCES OF HAZARDS IN PHARMA
Manufacturing and formulation installations.
Handling and storage of hazardous chemicals including warehouses,
godowns, tank forms in ports/fuel depots/docks.
Transportation (road, rail, air, water, pipelines).
Emission of pollutants – the air pollutants include carbon monoxide (CO),
nitrogen dioxide (NO2), particulate matter of 10 microns or less (PM10),
total suspended particulate matter (SPM), sulphur dioxide (SO2), and
volatile organic compounds (VOCs). The most common VOCs include
methanol, dichloromethane, toluene, ethylene glycol, N,Ndimethylformamide ,and acetonitrile.
Effluents, especially those that are not easily biodegradable and toxic in
nature. The effluent releases could go directly to streams, rivers, lakes,
oceans, or other bodies of water. The releases due to runoff, including
storm water runoff, could also be a potential hazard.
![Page 3: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/3.jpg)
3
HAZARDOUS WASTE – TYPES
these are in the form of liquids, solids, contained
gases or sludge.
This waste, containing spent solvents and other toxic organics in significant concentrations, requires treatment before it can be disposed of safely.
The toxic releases from the pharmaceuticals industry includes on-site discharge of a toxic chemical to the environment. This includes emissions to the air, discharges to bodies of water, releases at the facility to land, as well as contained disposal into underground injection wells.
Natural calamities like such as flood, cyclone, earthquake, tsunami.
![Page 4: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/4.jpg)
4
VARIOUS TYPES OF PHARMACEUTICAL WASTE –CHEMICAL WASTE
· Organic chemical residues from manufacturing processes
· Heavy metals
Dust during formulation
Gaseous Vapours / emissions during API /Bulk drugs
Chemical Spills
Leakages – water , oils, solvents , chemicals ,
![Page 5: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/5.jpg)
5
EXAMPLES OF CHEMICAL WASTE
Carcinogenic & other Chemicals used will explore every chances of gaseous/ fumes for Aromatic Amines , Benzene derivatives ,Solvents like Acetonitrile , Acetic Acid , Toluene, Methanol .
All are very hazardous for Environment & Occupation .
Needs Control measures especially in terms of EMS i.e. Environment Management System ( ISO 14001) and OHSAS – 18001 .
![Page 6: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/6.jpg)
6
MOST COMMON ENVIRONMENT HAZARDS BY PHARMA FIRM
The hazards from the pharmaceuticals could be categorized as:
Ecotoxic - damage is caused to the environment.
Carcinogenic - contribute to the causation of cancer.
Persistent - remain dangerous for a long time.
Bio-accumulative – accumulates as it makes its way up the food chain.
Disastrous due to a catastrophe, mishap, calamity or grave occurrence in any area.
![Page 7: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/7.jpg)
7
CONTD.
Water Pollution – because of spillage , drains and generation of effluent water , sewage water for uncontrolled pH , and treating it ineffectively . MOST dangerous for aquatic living organisms or their livelihood.
Air Pollution – releases of gaseous , fumes , dust , particulates to atmosphere , poor air quality ,
Land /Soil Pollution – Spillage , chemicals , oils , lubricants leakages to land /soil – seepage causation of non fertility to soil /lands , dumping or disposal of incinerated sludge unauthorized
Noise Pollution – persistent vibration in operating machines
, equipments , use of non acoustic power generators , air compressors .
![Page 8: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/8.jpg)
8
CONTD.
Odor :- spillage of blood , bio medical waste and culture burning in autoclave etc -poor effect on ambient air quality , -leading to mass air pollution and hazards to neighborhood – plants , trees, human , animals etc .
GLOBAL WARMING – CO2 Emission , CO , suspended particulates in atmosphere , NOx , - very sensitive issue globally now posing great threat of GLACIAL melting
Heat Stress :- Uncontrolled work environment , high temp , exothermic reactions , use of solvents , - very dangerous occupational hazard and also affecting ENVIRONMENT
![Page 9: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/9.jpg)
9
REGULATIONS AT NATIONAL LEVEL
At National Level :-
FACTORY ACT 1948 Compliance
MoEF Environmental Clearance
Environment Protection Act 1986
Environmental Statements Submission to Pollution Boards – Form V
Public Liability Act & Insurance 1991
MSDS for Hazardous materials and compliance
CCOE ( PESO ) License for classified solvent storage
Indian Electricity Act 1936 & rules
![Page 10: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/10.jpg)
10
CONTD.
Disaster Management Act -2005
Drugs & Cosmetic Act – 1940
Indian Boiler Act 1923
Hazardous Waste Management Act & Rules –
The Petroleum Act – 1934 & Rules -2002
The Explosives Act – 1884 & rules -1983
Central Motor Vehicles Act for HW or Goods carrying -1989
![Page 11: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/11.jpg)
11
REGULATIONS AT STATE LEVEL
Enforcement at STATE LEVEL :-
State Level Factory Rules -1963 and further amendments
Pollution Control Board Consent To operate – a) WATER ACT 1974 , b) AIR ACT -1984
Stack Monitoring Reports for emissions to Air
Work Environment monitoring – Ventilation , Illumination ,Dust & fumes
Noise Monitoring
Formation of SAFETY COMMITTEE as per 73 L
![Page 12: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/12.jpg)
12
CONTD.
Hazardous Waste Disposal Records (manifest)
Petroleum products storage on site – type ,storage , and License – class A solvents , Class B chemicals , HSD , LPG stock etc
Fire Hydrant system & FIRE NOC
Trained FIRST AIDERS
EPR & ERT – Emergency Preparedness & Response , Emergency Response Team
OHC – Occupational Health Centre , with Visiting Doctor & Male Nurse
![Page 13: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/13.jpg)
13
CONTD.
Approved Licensed Contractors
ESI of Employees /Contractors / Sub Contractors
Mock Drills – announced / un announced for Emergency Evacuation
Safety Committee Meetings & MOM
Safety & Environment Promotional Activities
![Page 14: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/14.jpg)
14
EXISTING GAPS & CONCERN
Non compliance too many –
Loose Controls on ETP , Casual Approach for ETP maintenance and Treatment
Air Pollution – No proper designing of scrubbers , venturies
Storm water and drain water common outlets , effluent load problems
Unskilled contract workers
Lack of SOP and training needs
Staff / workforce in adequate
![Page 15: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/15.jpg)
15
CONTD.
Lack of Preventive maintenance activities - Break downs , emissions , leakages –air , water pollution
Over capacity utilization of production schedules – system failure , leading to Air /Water /Land pollution
Old equipments – Poor Efficiency , trouble shooting ,
Poor electrical safety – negligence to earthing , fire hazard
Spillages , leakages of chemicals , oils , lubricants – water pollution , air pollution , ambience pollution
Gaseous emissions to atmosphere in night time high – Air Pollution , poor ambience , plants
Use of Non Acoustic D G sets - noise pollution , air pollution
![Page 16: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/16.jpg)
16
GAPS /CONCERNS FOR LEGAL
Non adherence to PCB consent norms – diluted standards
Erratic Behavior on SAFETY measures
Spillages , leakages –ignorance and poor maintenance cause for depletion of natural resources like water , power , forest , ozone layer depletion etc.
Non compliance of Annual Environment Returns – forged / manipulations in statement
Lack of Safety Standards .
![Page 17: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/17.jpg)
17
MANAGING WASTE COMING OUT FORM PHARMA FIRMS
Impact of Waste – from Pharma Firms
Air Pollution – 50 % of firms hazardous waste is wrongly handled , not as per MSDS requirements leading to spillage , open to evaporation , unclean dust collectors , inefficient scrubbers , use of scrubber absorption media for a long period .
Water Pollution :- Adverse functioning of ETP , lack of monitoring ETP by qualified personnel – leading to profuse water pollution , discharged to CETP with extra allowance , non standard use ETP material – in filtration , aeration ,
![Page 18: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/18.jpg)
18
CONTD.-
Spillage , Leakage , emissions , fumes , vapors direct impact on work place monitoring and AIR Quality .
Excessive wastages from R M , storage packing material consumptions ,resulting in to natural and other source depletions
Land fertility problems due to waste dumping
![Page 19: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/19.jpg)
19
COMMONLY APPLIED SYSTEMS (DO’S & DON’TS )
Most of the organization switching to water based / enzyme based products – API / formulations – improved Environment Controls for emissions, air quality and water pollution , optimize the process conditions
Organizations adapting to ISO -14001 – EMS for continual improvement
Work place environment and ambience improvements with designed Aspect /Impact controls , Waste minimization by improving material consumptions.
![Page 20: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/20.jpg)
20
CONTD :-
Even establishing OHSAS culture for Behavioral safety
Internal audits / self inspection to ensure conformance
Training to employees / contractors
Lock out /Tag Out Electrical system applied
Work Permit systems
![Page 21: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/21.jpg)
21
Do’s
GMP system – Process Approach , validation, compliance
Environment Controls during manufacturing , maintenance , storage , transportation , handling .
MSDS for base line requirements
Documentation and records of H W collection and disposal monitoring
Improve on Technology
Training of employees , contractors
![Page 22: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/22.jpg)
22
Do’s
Start Up / Shut Down procedures is must for better environment Controls
Improve on Engineering Controls to mitigate aspect /impacts also unsafe conditions and unsafe acts
Controls on interfaces of process
Establish EHS policy and communicate to all employees , contractors , visitors
Provide primary , secondary containments at spillages /leakages to arrest impact on environment
![Page 23: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/23.jpg)
23
Don’ts
Haste ,
Overloading of equipments
Small spills , leaks - ignorance
Use of excessive materials – R M , Packing etc .
short cuts , process bypasses
Critical process – untrained persons
![Page 24: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/24.jpg)
24
GOOD PRACTICES
Training to employees / contractors
Documentation
Recording
Self Inspections /Audits
Display of various Environment educative posters
Tool Box Talks at shop floors
Adoption of GMP
Consider ISO -14001 –EMS for continual improvement
![Page 25: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/25.jpg)
25
ROLE OF KEY ACTORS IN MANAGING THE WASTE COMING OUT PHARMA INDUSTRIES
Government (national and state levels)
Making Policies & Establish
Refreshing the changes / amendments in policies , directives through Web , Media and Updating the MoEF Consents
Survey of Industrial areas though PCB , DISH
Creation of CETP or Enviro Collection centers in Industrial outlets
Air Monitoring at Industries
Work Place Environment monitoring
![Page 26: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/26.jpg)
26
CONTD.-
Central & State Pollution Control Boards
Independent , Full Time MEMBER SECRETARY at PCB Apex level of IAS grade .
Creation of Regional PCB at all District level to ease out local issues
Public Liability Insurance Act 1991 made mandatory for off site emergency
Central Hazardous waste collection areas ear marked by PCB to avoid unauthorized and suspicious dumping
Provision of CETP
Industrial frequent visits and follow up on critical env.issues
![Page 27: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/27.jpg)
27
CONTD,-
Violation memos to trouble shooter industries
Show cause Notices on major violation of EPA 1986 act
Shut down of major problematic Industries
Mandatory to file /submit quarterly hazardous waste statement to PCB
In line WEB access to all industries by PCB for ease of submission and monitoring by them .
![Page 28: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/28.jpg)
28
DRUG CONTROLLER NATIONAL & STATE LEVEL
Responsible for Drug & Cosmetic act enactment in pharma industries.
Empowered by Ministry of Chemicals for effective implementation of Drug & Cosmetic act in totality
Sampling of vehicles and industries for controls taken on hazardous waste generation and it’s disposal
![Page 29: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/29.jpg)
29
PHARMACEUTICAL ASSOCIATIONS CHEMIST ASSOCIATIONS
Interactions , dialogues with local industrial for their problem
Arranging work shops / seminars through associations to diffuse the gravity situations and joint forums to mitigate issues of hazardous waste
Making presentation to Drug Authorities for facts and getting their help in disposal of hazardous waste like creation of authorized dumping outlets,
Creation of CETP or Enviro care centers through follow up with Regulatory authorities and standardize practices
Helping to small scale industries through Training and awareness for acquainting to Pollution /Environment Controls
![Page 30: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/30.jpg)
30
MEDICAL REPRESENTATIVE ASSOCIATIONCONSUMERS/CITIZENS GROUPS
Main role by these group is expected through campaigning for hazardous waste generation by consumers through blisters , primary secondary packing material coming out of drug usage
This group to educate hospitals , nursing staff , dispensary staff for impact of packing material in Environment
Hazards of handling such waste while as an end user
It is expected also by this group to share feedback from customers- direct/ indirect agencies to pharma company so that there will be further improvement to mitigate on issues of hazardous waste by technology developments and less impact on environment
![Page 31: 2 SOURCES OF HAZARDS IN PHARMA Manufacturing and formulation installations. Handling and storage of hazardous chemicals including warehouses, godowns,](https://reader036.vdocuments.site/reader036/viewer/2022062712/56649c855503460f9493c60f/html5/thumbnails/31.jpg)
31
END OF SESSION
THANKS