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RISK ASSESSMENT
CARACTERIZAO GERAL DO RISCO
Higiene Ocupacional
Prof. Jos Pedro Dias Jr, MSc, HOC, RSO
JK RISK ASSESSMENT
OBJETIVOS
Mostrar uma prtica que ajuda o Risk Assessment (RA =
Reconhecimento do Risco)
Risk Assessment Qualitativo (QLRA)
Processo para tomada de deciso para verificar a necessidade
do Quantitative Risk Assessment Quantitativo(QTRA)
Processo de Amostragem
Analise Estatistica Bayesian Statistics
Fator de Proteo Respiratoria (FPR ou RPF)
Procedimentos para o Controle da Exposio
28/03/2015
INTRODUO
RISK ASSESSMENT
Processo farmacutico
Particularidades na Farmacutica:
Presena de Compostos Potente
Limites de Exposio Muito Baixos(qdo existem)
Dados
Toxicolgicos
necessrios
e difceis
de serem
28/03/2015
Reconhecimento Qualitativo
OELB = Interno Occupational Exposure Band
PBOEL Health Hazard Rating Criteria
PBOEL 3B-Highly
Hazardous
PBOEL 3AHighly/Moderately
Hazardous**
PBOEL 1A - Low
Hazardous
5 - <20 g/m3
20 <100 g/m3
Acute toxicity
<0.1
Extreme
<0.1
High
0.1-10
High/Moderate
10-100
Moderate/Low
100 - 1000
Low
> 1000
Low/None
Life trreatening/Fatal
High
High/Moderate
Moderate/Low
Low
Low/None
None
Poor
Poor/Fair
Fair
Good
Good
None
Delayed
May be delayed
May be
delayed/Immediate
Immediate
Immediate
Medically treatable
No/Yes
Yes
Yes
Yes
Yes
Yes
be required
Need for medical intervention Required immediately May
immediately
May be required
Not required
Not required
Not required
4-Extremely
PBOEL Health Hazard Ratings PBOEL
Hazardous***
OEL Range (ug/m3)
General Enrollment Criteria
Potency (mg/day)
Probable
Possible
Possible/Unlikely
Unlikely
Unlikely
Known/Probable
High
Moderate
Mild
None
None
Reversibility
Reversible
Reversible
Reversible
Yes
Yes/No
No
No
No
Irreversible
Carcinogenicity
Strong sensitizer
(RSEN)
Severe
Moderate irritant
Moderate/Mild Irritant
Non-irritant
Non-irritant
Sensitizer (RSEN)
Sensitizer (RSEN)
Non-sensitizer
Non-sensitizer
Non-sensitizer
RISK ASSESSMENT
Manipulao de APIs (Active Pharmaceuthical Ingredients :
Risk Assessment Qualitativo - Sempre & Profundo
Risk
Assessment
Quantitativo
(se
QLRA
indicar
necessidade)
** No precisamos medir / avaliar tudo... Porm avaliar
apenas a exposio a particulados, no resolve.
Procedimento utilizado neste caso:
RBEAP - Risk Based Exposure Assessment Process = J&J
Instrumento interno que considera o Pior Cenrio
RISK ASSESSMENT
28/03/2015
IH EXPOSURE
ASSESSMENT
RISK ASSESSMENT
PRIORIZATION
RISK BASED EXPOSURE
ASSESSMENT- STATISTICS
SAMPLING PLAN
RESPIRATORY PROTECTION
HEARING CONSERVATION
OCCUP.MED. INFORM
IH SAMPL METHOD
OEL DEVELOPM
PROTECT WORKER
LOCAL REGULATION
INTERNAL GUIDELINES
COST AVOID
RISK ASSESSMENT
How it starts?
QLRA=KEY
Tomada
de
Deciso
28/03/2015
RISK ASSESSMENT
Como comea?
Reconhecimento Qualitativo:
Principais Riscos Higiene Ocupacionl
Tomada de
Deciso?
Different Products
OELB
(ug/m3)
OEL
(ug/m3)
Dustines
STEL
Particle
Assigned
s
Size (u)
(Y/N)
(Y/N)
Solid
Matrix
(Y/N)
RPE
% of
Worst case Required?
Batch
Active
Type
(H-M-L)
Size(kg)
in Batch
(before)
Acetaminophen
Tablet 750 mg
coated
1A
3000
No
250
Yes
Yes
1050 99,70%
High
Levofloxacina
Tablet 500 mg
Coated
1A
1250
No
N.A.
Yes
Yes
100
75,45%
High
Yes/HM
Vitamina A
Acetato
Rarical
Coated
3A
11
No
N.A.
Yes
Yes
420
1,30%
Low
Yes/ Air
Mate
cido Ascrbico
Rarical B
Coated
420
8,07%
Low
Yes/ Air
Mate
Paralon
Revestido
10000
No
N.A.
Yes
Yes
1A
3000
No
250
Yes
Yes
1B
500
No
N.A.
Yes
Yes
RPE
Required
After Data
Collected
Yes/HM
28/03/2015
ESTIMATIVA DE CUSTOS
API/Product Technical Details
API/ Chemical
Different Products
OELB
(ug/m3)
OEL
(ug/m3)
Dustines
STEL
Particle
Assigned
s
Size (u)
(Y/N)
(Y/N)
Solid
Matrix
(Y/N)
RPE
% of
Batch
Worst case Required?
Active
Type
(H-M-L)
Size(kg)
in Batch
(before)
Acetaminophen
Tablet 750 mg
coated
1A
3000
No
250
Yes
Yes
1050 99,70%
High
Levofloxacina
Tablet 500 mg
Coated
1A
1250
No
N.A.
Yes
Yes
100
75,45%
High
Yes/HM
Vitamina A
Acetato
Rarical
Coated
3A
11
No
N.A.
Yes
Yes
420
1,30%
Low
Yes/ Air
Mate
cido Ascrbico
Rarical B
Coated
10000
No
N.A.
Yes
Yes
420
8,07%
Low
Yes/ Air
Mate
6 PRODUTOS DIFERENTES
RPE
Required
After Data
Collected
Yes/HM
Paralon
Revestido
1A
3000
No
250
Yes
Yes
1B
500
No
N.A.
Yes
Yes
PROCESSO: PESAGEM
API
Product
Acetaminophen
Tablet 750 mg
revestido
% API
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Acetaminophen
Tablet 750 mg
revestido
0,997
Sampling
Date
Sampling Worst
8 Hour
Results
Time
Case
TWA
(ug/m3)
(min)
(H/M/L)
(ug/m3)
15/mar/07
294
12/mar/07
330
13/mar/07
302
05/jun/07
330
17/jul/07
330
08/ago/07
330
06/out/07
315
08/nov/07
328
16/nov/07
360
17/nov/07
330
Alto
280
Alto
200
Alto
530
Alto
190
Alto
39
Alto
180
Alto
270
Alto
100
Alto
280
Alto
940
Comments
No RP Required
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RPF = 10
RPF = 10
RPF = 1000
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PROCESSO: Pesagem
Product
OELB
(ug/m3)
OEL
(ug/m3)
STEL
Assigned
(Y/N)
Particle
Size (u)
Dustiness
(Y/N)
Solid
Matrix
(Y/N)
% of
Worst case
Batch
Active in
(H-M-L)
Size(kg)
Batch
RPE
Required?
Type
RPE Required
After Data
Collected
Alto
Sim/HM
NR
1- Acetaminophen
Tablet 750 mg
coated
1A
3000
No
250
Sim
Sim
1050
99,70%
1- Levofloxacina
Tablet 500 mg
Coated
1A
1250
No
N.A.
Sim
Sim
100
75,45%
Alto
Sim/HM
FP 10
1- Vitamina A
Acetato
Rarical
Coated
3A
11
No
N.A.
Sim
Sim
420
1,30%
Baixo
Sim/ Air
Mate
FP 1000
1A
3000
No
250
Sim
Sim
200,0
49,75%
Mdio
Sim/HM
NR
1- Clorzoxazona
1B
500
No
N.A.
Sim
Sim
200
16,50%
Mdio
Sim/HM
FP 10
Paralon Revestido
BIG PICTURE
28/03/2015
Reconhecimento quantitativo
Reconhecimento quantitativo
Determinar FP adequado
Concluses
1. Abordagem baseada no risco, priorizando amostragem,
tempo e os custos
2. Fornece uma viso geral sobre a exposio mesmo quando
no h amostragem disponvel ou mtodo analtico
3. Fornece um panorama geral de uma situao quando no h
informaes sobre o processo
4. Oferece informaes importantes sobre requisitos de EPI FPR", com base cientfica
5. Permite que voc use um nmero menor de amostras
considerando a utilizao da Estatstica Bayesiana
28/03/2015
REFERENCIAS
Guias de treinamento
EXPOSURE ASSESSMENT GUIDELINE
Planos de trabalho Gerais
OBRIGADO
10
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JK RISK ASSESSMENT
JK RISK ASSESSMENT
Estrutura de
alumnio
Cmara de
entrada / sada
do vestbulo
Mdulo de exausto
Cmara de exausto
(HEPA) ligada ao
enclausuramento principal
via duto flexvel para
induzir a pressurizao
negativa
11
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JK RISK ASSESSMENT
Flexibel containment
Estufa
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Misturador V
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GRANULADOR COLLETE
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MOINHO FITZMIL
JK RISK ASSESSMENT
Cilindro de
transferncia
enclausurado
Manga
para
fixao
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COMPRESSORAS
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JK RISK ASSESSMENT
Resultados visveis
JK RISK ASSESSMENT
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Caso 2: Pesagem
100% active
22 Kg
OEL 0.9 g/m3
API transferred from its original
container with a scoop.
JK RISK ASSESSMENT
JK RISK ASSESSMENT
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Caso 5
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JK RISK ASSESSMENT
Baixo Custo
Fcil instalao
Reduz a exposio
Eliminao da Proteo Respiratria
Sistema flexvel e fcil de ser aplicado em diferentes equipamentos
Reduz contaminao cruzada
Mudanas podem ser feitas facilmente
Descartvel
Materiais utilizados so aprovados por FDA e EU Compliant Materials (GMP)
Rpida limpeza entre lotes
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Resumo / Concluso
19