Pharma OEB Best Practice

Pharmaceutical Industry Best

Practice

1) Identify the operation/activity to be performed in the far-left column of the chart.

2) Identify the OEB of the API handled or processed during the operation/activity in the top row of the chart.

3) Find the intersection point of the identified OEB and activity. This is the suggested containment control strategy for the

activity performed.

Suggested Containment Control Strategy and Personal Protective

Equipment based on Active Pharmaceutical Ingredient

Occupational Exposure Banding

In order to properly use the information contained in the tables below, active pharmaceutical ingredients (API) must be eval-

uated and placed into an Occupational Exposure Band (OEB).

Occupational exposure banding,

also known as hazard banding, or health hazard banding, is a process intended to quickly and

accurately assign chemicals into specific categories (bands), which correspond to a range of exposure concentrations

designed to protect worker health. These bands are assigned based on a chemical’s toxicological potency and the adverse

health effects associated with exposure to the chemical.

The output of this process is an occupational exposure

band. [McKernan L, Seaton M, Gilbert S [2016]. The NIOSH Decision Logic for OEBs: Applying Occupational Exposure Bands.

The Synergist (March 2016)].

Each band describes a distinct range of Occupational Exposure Limits (OELs), grouped so that a single recommendation for

exposure control technology and personal protective equipment (PPE) can adequately protect employees engaged in

similar tasks or process.

Information and tables included in this document are not intended to cover all tasks or situations, and may not be applicable

for some or all of a company’s specific operations. A detailed analysis should be conducted to determine applicability.

How to Use This Best Practice Guide

Use of this guide and suggestions herein are not a substitute for a complete and robust risk assessment and exposure

assess

-ment program. Good industrial hygiene and occupational exposure banding practices should be implemented and

followed.

Suggested Containment Control Strategy

Figure 1: EXAMPLE – Dispensing/weighing wet powder in OEB 4

Suggested Personal Protective Equipment

1) Identify the operation/activity to be performed in the far-left column of the chart.

2) I

dentify the OEB of the API handled or processed during the operation/activity in the top row of the chart.

3) F

ind the intersection point of the identified OEB and activity. This is the suggested personal protective equipment for

the activity performed, without regard to engineering controls/containment.

Figure 2: EXAMPLE – Weighing powder in OEB 3

Pharmaceutical Industry Best

Practice

Suggested Containment Control Strategy for Lab & Areas

Outside Manufacturing & Pilot Plant

This chart offers suggestions only and should not be used without verifying that the technology works for your unique

situation.

Activity

Occupational Exposure Band (OEB)

OEB 1 & 2

OEB 3 OEB 4

OEB 5

(100 µg/m

) (>10 - 100 µg/m

)

(> 1 - 10 µg/m

)

(< 1 µg/m

)

Sample transfer

Tightly sealed container or zip-lock plastic bags

Double sealed container (e.g. bottle in bag)

Dry Powders weighing

and handling (Drying etc.)

Open Handing <1g

API permitted (VBSE

recommended) >1g

VBSE required

VBSE

VBSE or Isolator (if

quantity >10g) with

appropriate contained

transfer device.

VBSE or Isolator (if

quantity >1g) with

appropriate contained

transfer device.

Wet Powders handling

(weighing, filtration and

cake handling)

Containment Hood

Containment Hood,

For quantities >100 g,

use VBSE or Isolator

Containment Hood. For

quantities >10 g, use

VBSE or Isolator

Solution/Suspension

handlingOpen Bench

permitted with spill trays.

Containment Hood if

solvents are used or

aerosolization may

occur

Open Bench permitted. Containment Hood if

solvents are used or aerosolization may occur

Tablets (coated /

uncoated) and capsules

manipulation

VBSE or Containment

Hood

VBSE or Containment Hood

Returned Sample Handling

of broken or leaking

presentations and

uncoated tablets

VBSE Recommended

Returned Sample Handling

of intact:Coated tablets,

capsules, vials, patches,

bottles

Open Handling

Open Bench permitted with spill trays

Containment Hood if solvents are used or

aerosolization may occur

VBSE or Containment Hood

VBSE Recommended

Open Handling

VBSE = Vented Balance Safety Enclosure

Table A.

Pharmaceutical Industry Best

Practice

Suggested PPE for Lab & Areas Outside Manufacturing & Pilot

Plant. For operations with insufficient and/or unverified

engineering controls

For operations with insufficient and/or unverified engineering controls.

This chart offers suggestions only and should not be used without verifying that the Personal Protective Equipment (PPE) is

appropriate for your unique situation.

Activity

Occupational Exposure Band (OEB)

OEB 1 & 2 OEB 3, 4 & 5

(100 µg/m

)

(< 100 µg/m

)

Powder Manipulation

Min required lab PPE, gloves

Minimum lab PPE, gloves and appropriately fitted ½ facepiece

particulate respirator

Solutions & Suspensions

(No aerosols)

Minimum required Lab

PPE, gloves

Minimum required lab PPE, gloves, lab coat, safety glasses and

spill trays

Potentially

Contaminated Batch

Record Handling

NA Minimum lab PPE, gloves, lab coat, safety glasses

Returned Sample

Handling of broken or

eaking presentations

and uncoated tablets

Min required lab PPE, gloves

Minimum lab PPE, gloves, lab coat, safety glasses

Table B.

Pharmaceutical Industry Best

Practice

Suggested Personal Protection Equipment for Production/Pilot

Plant (without regards to engineering controls/containment

strategy)

This chart offers suggestions only and should not be used without verifying that the technology works for your unique

situation.

Activity

Occupational Exposure Band (OEB)

OEB 1 OEB 2 OEB 3 OEB 4 OEB 5

(1000 µg/m

)

(>100 - 1000 µg/m

)

(>10 - 100 µg/m

)

(> 1 - 10 µg/m

)

(< 1 µg/m

)

Weighing

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment for

the area.

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment

for the area.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, gloves

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

QA Sampling ½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment for

the area.

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment

for the area.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, gloves

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

Granulation/

Compounding

& Other

Powder

Manipulation

Processes

(assuming EC

not at

prescribed

levels)

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment for

the area.

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment

for the area

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, gloves.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

GMP = Good Manufacturing Process

APF = Assigned Protection Factor

PAPR = Powered Air Purifying Respirator

HEPA = High Efficiency Particulate Air

Table C.

Activity

Occupational Exposure Band (OEB)

OEB 1 OEB 2 OEB 3 OEB 4 OEB 5

( 1000 µg/m

)

(>100 - 1000 µg/m

)

(>10 - 100 µg/m

)

(> 1 - 10 µg/m

)

(

< 1 µg/m

)

Compression/

Encapsulation

Gloves, long sleeved

GMP clothing and

safety equipment

for the area.

½ mask respirator,

gloves, GMP and

safety equipment

for the area.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, gloves.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

Unless hand

scooping is used

then ½ mask

respirator, gloves,

long sleeved GMP

clothing and safety

equipment for the

area.

Coating

Gloves, long sleeved

GMP clothing and

safety equipment

for the area.

Gloves, long sleeved

GMP clothing and

safety equipment for

the area.

Working in the area

before or after the

pan has been

charged - ½ mask

respirator, gloves,

long sleeved GMP

clothing and safety

equipment for the

area.

Working in the

area before or after

the pan has been

charged - ½ mask

respirator, gloves,

long sleeved GMP

clothing and safety

equipment for the

area.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable coveralls

(Category III), and

booties.

Charging the coating

pan - ½ mask

respirator, gloves,

long sleeved GMP

clothing and safety

equipment for the

area.

Charging the coater

- PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, gloves.

Charging the coater

- PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable coveralls

(Category III), and

booties.

Solutions/

Suspensions

(no

aerosolization

or powders.

Gloves, long sleeved

GMP clothing and

safety equipment

for the area.

Gloves, long sleeved

GMP clothing and

safety equipment

for the area.

Gloves, long sleeved

GMP clothing and

safety equipment for

the area.

Gloves, long sleeved

GMP clothing and

safety equipment for

the area.

Gloves, long sleeved

GMP clothing and

safety equipment for

the area.

Table C.

Continued...

BIBO = Bag In Bag Out

Activity

Occupational Exposure Band (OEB)

OEB 1 OEB 2 OEB 3 OEB 4 OEB 5

( 1000 µg/m

)

(>100 - 1000 µg/m

)

(>10 - 100 µg/m

)

(> 1 - 10 µg/m

)

(

< 1 µg/m

)

Packaging

(uncoated

tablets, hot

side work)

Gloves, long sleeved

GMP clothing and

safety equipment

for the area.

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment for

the area.

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment

for the area.

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment

for the area.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied

air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

During cleaning and

hopper filler

operator - PAPR w/

full hood with max

APF and HEPA

filter or supplied air,

double gloves

(Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

Packaging

coated

tablets,

capsules,

liquids, or cold

side work

Gloves, long sleeved

GMP clothing and

safety equipment

for the area.

Gloves, long sleeved

GMP clothing and

safety equipment for

the

area.

Gloves, long sleeved

GMP clothing and

safety equipment

for the area.

Gloves, long

sleeved GMP

clothing and safety

equipment for the

area.

Gloves,

long sleeved

GMP clothing and

safety equipment for

the area.

Dust Collector

Change Out

(HEPA or

waste)

BIBO HEPA’s should

be used.

BIBO HEPA’s

should be used.

BIBO HEPA’s

should be used for

HEPA cartridge

change out.

BIBO HEPA’s should

be used for HEPA

cartridge change

out.

BIBO HEPA’s

should be used for

HEPA cartridge

change out.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped

cuffs), disposable or

launderable

coveralls (Category

III), and booties.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped

cuffs), disposable or

launderable

coveralls (Category

III), and booties.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

PAPR w/ full hood

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III), and booties.

Table C.

Continued...

Personnel

Decontamin-

ation

Decontamination

procedure required

Decontamination

procedure required

Decontamination

procedure required

Decontamination

procedure required

Decontamination

procedure required

PPE

decontamination is

required upon

leaving the area.

PPE

decontamination is

required upon

leaving the area.

PPE

decontamination

is required prior to

leaving the area.

Ensure

contamination

doesn’t occur or isn’t

spread outside the

area (personnel

and

equipment, materials

etc.)

Ensure

contamination

doesn’t occur or isn’t

spread outside the

area (personnel and

equipment, materials

etc.)

Ensure

contamination

doesn’t occur or isn’t

spread outside the

area (personnel and

equipment,

materials etc.)

Emergency

Containment

Breaches

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment

for the area.

½ mask respirator,

gloves, long sleeved

GMP clothing and

safety equipment

for the area.

PAPR w/ full hooded

head top with max

APF and HEPA filter

or supplied air,

gloves

PAPR w/ full hooded

head toped head top

with max APF and

HEPA filter or

supplied air, double

gloves (Taped cuffs),

disposable or

launderable

coveralls (Category

III equivalent), and

booties.

PAPR w/ full

hooded head top

with max APF and

HEPA filter or

supplied air, double

gloves (Taped

cuffs), disposable or

launderable

coveralls (Category

III equivalent), and

booties.

Activity

Occupational Exposure Band (OEB)

OEB 1 OEB 2

OEB 3

OEB 4 OEB 5

( 1000 µg/m

)

(>100 - 1000 µg/m

)

(>10 - 100 µg/m

)

(> 1 - 10 µg/m

)

(< 1 µg/m

)

Table C. Continued...

Pharmaceutical Industry Best

Practice

Suggested Containment Control Strategy for Production or

Pilot Plant

This chart offers suggestions only and should not be used without verifying that the technology works for your unique

situation.

Activity

Occupational Exposure Band (OEB)

OEB 1 & 2 OEB 3 OEB 4 OEB 5

(≥100 µg/m

) (>10 - 100 µg/m

) (>1 - 10 µg/m

) (≤1 µg/m

)

Dispensing/ Weighing

-Wet Powders

NA LEV

LEV or Down flow

booth

Down flow booth with

barriers or curtains or

isolator with contained

transfer ports

Dispensing/ Weighing

-Dry Powders

LEV

LEV or Down flow

booth or ventilated

enclosure

Down flow booth with

barriers or curtains or

isolator with contained

transfer ports

Isolator with contained

transfer ports

Dispensing dry powders

into liquids Appropriate

contained transfer

technology, (e.g. SBV,

PTS, DCS, etc.), direct

connection between

processing units or

isolator Solids/liquids

disperser/ homogenizer -

recommended

Solids/liquids disperser/ homogenizer -

recommended

Powder Sampling (when

dedicated sampling port

is not available)

LEV

LEV or Down flow

booth

Down flow booth

PAT, isolator or through

appropriate contained

transfer device

TD Centrifuge

Discharge Isolator/

glove bag or change

technology

BD Centrifuge

ischarge

Suitable enclosure (e.g.

inflatable seal)

Suitable continuous liner

Appropriate contained

transfer device or

isolator with contained

transfer ports

Appropriate contained transfer technology,

(e.g. SBV, PTS, DCS, etc) , direct connection

between processing units or Isolator

Solids/liquids disperser/homogenizer -

recommended

Isolator/glove bag or change technology

Table D.

Hor. Centrifuge

Discharge

Suitable enclosure (e.g.

inflatable seal)

Suitable continuous liner

Appropriate contained

transfer device or

isolator with contained

transfer ports

Inv. Basket Centrifuge

Discharge

Suitable enclosure (e.g.

inflatable seal)

Suitable continuous liner

Appropriate contained

transfer device or

isolator with contained

transfer ports

Other Liquid Filtration

systems when solids are

waste

Thoroughly wash out

the unit before opening

for disposal

Safely dispose after proper wetting. Use disposable

bags/ cartridges if possible. Dispose in contained

manner, e.g. while using “Bag in Bag” or “Cartridge

in Bag” technology

Filter Dryer Discharge LEV or Suitable

enclosure

Suitable enclosure (e.g.

inflatable seal)

Suitable continuous liner or other appropriate

contained transfer technology

Fluidized Bed Dryer or

Spray Dryer Charging LEV

LEV and direct

connection or remote

charging

Appropriate contained transfer using vacuum,

gravity or both. (SBV or similar if disconnections are

required)

Fluidized Bed Dryer or

Spray Dryer Discharging LEV

LEV and direct

connection

Contained transfer technology (Vacuum system for

side discharge or bottom gravity discharge with

SBV)

Fluidized Bed Dryer or

Spray Dryer

CleaningWIP or Glove

Bag/Box Isolator

HEPA vacuum and wet methods

Tray Dryer Charge NA if

aterial is wet enough If

not see discharge below

LEV recommended

Tray Dryer Discharge

Down flow booth with

barriers or curtains,

isolator or change

technology (one Pot

etc.)

LEV or down flow booth

Lyophilizing/ Freeze

Drying Discharge Down

flow booth with barriers

or curtains or isolator

LEV

Lyophilizing/ Freeze

Drying Cleaning WIP,

Vial wash down or

Glove Bag/Box Isolator

HEPA vacuum and wet methods

Activity

Occupational Exposure Band (OEB)

OEB 1 & 2 OEB 3 OEB 4 OEB 5

(≥100 µg/m

) (>10 - 100 µg/m

) (>1 - 10 µg/m

) (≤1 µg/m

)

WIP or Glove Bag/Box Isolator

NA if material is wet enough

If not see discharge below

Down flow booth with barriers or curtains,

isolator or change technology (one Pot etc.)

Down flow booth with barriers or curtains or

Isolator

WIP, Vial wash down or Glove Bag/Box Isolator

Table D. Continued...

Vacuum Dryers

Charge/DischargeDirec

t connection with

appropriate contained

transfer device

Direct connection

Vacuum Dryers

CleaningWIP or CIP

through appropriate

contained transfer

device or built in

Direct connection

Tumble Blending (V, Bin,

Cone), Charging/

Discharging

LEV

LEV and direct

connection

Appropriate contained transfer device

Tumble Blending (V, Bin,

Cone), Cleaning WIP or

CIP through appropriate

contained transfer device

or built in

HEPA vacuum and wet methods

High Sheer Mixing/

Granulating

Charge/Discharge

LEV

LEV and direct

connection

Appropriate contained transfer device

High Sheer Mixing/

Granulating Heel

Removal

LEV

LEV and direct

connection

Isolator/glove bag for product heel removal or one

pot processor

High Sheer Mixing/

Granulating Cleaning

WIP or CIP through

appropriate contained

transfer device or built in

HEPA vacuum and wet methods

Tablet Coating Charge

Appropriate contained

transfer device

LEV (may be built in)

Tablet Coating

Cleaning WIP (may

be built in)

HEPA vacuum and wet methods

Roller Compactor

harge/Discharge LEV or down flow booth

LEV and direct

connections or down

flow booth

Appropriate contained transfer device, leak proof

seals

Activity

Occupational Exposure Band (OEB)

OEB 1 & 2 OEB 3 OEB 4 OEB 5

(≥100 µg/m

) (>10 - 100 µg/m

) (>1 - 10 µg/m

) (≤1 µg/m

)

Direct connection with appropriate contained

transfer device

WIP or CIP through appropriate contained transfer

device or built in

WIP or CIP through appropriate contained transfer

device or built in

WIP or CIP through appropriate contained transfer

device or built in

Appropriate Contained transfer device

WIP (may be built in)

Table D. Continued...

Roller Compactor

CleaningWIP/CIP or

Isolator

HEPA vacuum and wet methods

Milling

CleaningWIP/CIP or

Isolator

HEPA vacuum and wet methods

Milling Charge,

ischarge & Operation LEV or down flow booth

LEV and direct

connections or down

flow booth

Appropriate contained transfer device, leak proof

seals

Sieving/Screening

Charge/Discharge LEV or down flow booth

LEV and direct

connections or down

flow booth

Appropriate contained transfer device, leak proof

seals

Seiving/Screening

CleaningWIP/CIP or

isolator

HEPA vacuum and wet methods

Packaging Hopper

illing & Operation

(uncoated tablets or

powder

filling) Appropriate

contained transfer

device for the hopper (if

possible), and contained

ventilated filler

LEV at hopper and filler

Packaging Hopper/Filler

Cleaning (uncoated

tablets or powder

filling) WIP, Mist in

Place or Isolator

HEPA vacuum

Compression &

Encapsulation Charging

LEV

LEV & drum lift & direct

connection

Appropriate contained transfer device

Compression &

Encapsulation In

Process Checks

Automated or

contained (VBSE, etc.)

Compression/

Encapsulation Product

Recovery

LEV

LEV and direct

connection

Safe change Vacuum system or Cyclone with

contained transfer device and WIP or CIP

Activity

Occupational Exposure Band (OEB)

OEB 1 & 2 OEB 3 OEB 4 OEB 5

(≥100 µg/m

) (>10 - 100 µg/m

) (>1 - 10 µg/m

) (≤1 µg/m

)

WIP/CIP or Isolator

WIP/CIP or isolator

Appropriate contained transfer device for the hopper

(if possible), and contained ventilated filler

WIP, Mist in Place or Isolator

Automated or contained (VBSE, etc.).

Table D. Continued...

Compression/

Encapsulation

Cleaning

WIP or CIP

or Isolator

HEPA vacuum

Extruding &

Spheronizing

Charging/ Discharging

Appropriate Contained

transfer device

LEV

Extruding &

Spheronizing Cleaning

WIP or CIP or Isolator

HEPA vacuum and wet methods

Vacuum Cleaner Bag

Change Out BIBO Filter

change and appropriate

contained transfer

device

LEV

Container TyperSuitable

Contained - required

Suitable Container - recommended

Transdermal Film

Coating Additional

specific local ventilation

or containment required

to control volatile APIs

or solvents

Additional specific local ventilation or containment

recommended to control volatile APIs or solvents

Personnel

Decontamination

Methods Required -

Misting Shower for

decontamination of

Personnel PPE, etc.,

policy and training

Unless, In Controlled

containment:

Recommended

Equipment/ Material

Transfer Contaminated

items must be cleaned

or contained prior to

transfer. Cleaning with

Compressed Air is not

allowed

Contaminated items must be cleaned or contained

prior to transfer. Cleaning with Compressed Air is

not allowed.

Activity

Occupational Exposure Band (OEB)

OEB 1 & 2 OEB 3 OEB 4 OEB 5

(≥100 µg/m

) (>10 - 100 µg/m

) (>1 - 10 µg/m

) (≤1 µg/m

)

WIP or CIP or Isolator

Appropriate Contained transfer device

WIP or CIP or Isolator

BIBO Filter change and appropriate contained

transfer device

Suitable Container - required

Additional specific local ventilation or containment

Required to control volatile APIs or solvents

Required - Misting Shower for decontamination of

Personnel PPE, etc., policy and training

Unless, In Controlled containment: Recommended.

Contaminated items must be cleaned or contained

prior to transfer. Cleaning with Compressed Air is

not allowed.

Table D. Continued...

APF – Assigned Protection Factor

API – Active Pharmaceutical Ingredient

BIBO – Bag In Bag Out

BD – Bottom Discharge

BSC – Bio-safety Cabinet

CIP – Clean In Place

DCS – Distributed Control System

FA – Fresh Air

FBD – Fluidized Bed Dryer

GMP – Good Manufacturing Process

HEPA – High Efficiency Particulate Air IPI

–

Isolated Process Intermediate Isolator –

Glove Box or Flexible Glove Bag

Batch Record Handling

Electronic Batch

Records or Glove Box

or Recording done in an

uncontaminated area

Unless, In Controlled

containment: NA

Activity

Occupational Exposure Band (OEB)

OEB 1 & 2 OEB 3 OEB 4 OEB 5

(≥100 µg/m

) (>10 - 100 µg/m

) (>1 - 10 µg/m

) (≤1 µg/m

)

Electronic Batch Records or

Glove Box or

Recording done in a uncontaminated area

Unless, In Controlled containment – NA

Table D. Continued...

LEV – Local Exhaust Ventilation

NA – Not Applicable

OEB – Occupational Exposure Band

OEL – Occupational Exposure Limit

PAT – Process Analytical Technology

PPE – Personal Protective Equipment

PTS – Powder Transfer System

SBV – Split Butterfly Valve

TD – Top Discharge

V – V-shaped style tumble blender

VBSE – Ventilated Balance Safety Enclosure

WIP - Wash In Place

Disclaimer

3M disclaims any and all liability, loss, or risk resulting directly or indirectly from the use of the suggestions presented in this

document.

Moreover, it is ultimately the employer’s responsibility to provide a place of employment which is free from

recog-nized hazards that are causing or are likely to cause death or serious physical harm to his employees, and to comply

with local occupational safety and health standards and regulations.

Compliance with suggestions made in this document does not certify compliance with federal, state or local regulations. No

warranties are made, as these documents only present suggestions that may be applicable for work in these environments.

Personal Safety Division

3M Center, Building 235-2W-70

St. Paul, MN 55144-1000

3M PSD products are

occupational use only.

3M is a trademark of 3M Company and affiliates.

Used under license in Canada. All other trademarks

are property of their respective owners.

Please recycle. January, 2019

In United States of America

Technical Service: 1-800-243-4630

1-800-328-1667

1-800-267-4414

1-800-364-3577

Customer Service:

3M.com/workersafety

In Canada

Technical Service:

Customer Service:

3M.ca/Safety