HG067-2.33 Gowning Procedures

GEN-034GEN-034Gowning ProcedureGowning Procedure

This product was funded by a grant awarded under the President’s This product was funded by a grant awarded under the President’s High Growth Job Training Initiative as implemented by the U.S. High Growth Job Training Initiative as implemented by the U.S.

Department of Labor’s Employment & Training Administration. The Department of Labor’s Employment & Training Administration. The information contained in this product was created by a grantee information contained in this product was created by a grantee

organization and does not necessarily reflect the official position of organization and does not necessarily reflect the official position of the U.S. Department of Labor. All references to non-governmental the U.S. Department of Labor. All references to non-governmental companies or organizations, their services, products, or resources companies or organizations, their services, products, or resources are offered for informational purposes and should not be construed are offered for informational purposes and should not be construed

as an endorsement by the Department of Labor. This product is as an endorsement by the Department of Labor. This product is copyrighted by the institution that created it and is intended for copyrighted by the institution that created it and is intended for

individual organizational, non-commercial use only.individual organizational, non-commercial use only.

Learning ObjectivesLearning Objectives

Establish gowning requirements for those Establish gowning requirements for those areas identified as GMP Zones (GMP areas identified as GMP Zones (GMP areas designated by gowning requirement, areas designated by gowning requirement, environmental controls & frequency of environmental controls & frequency of cleaning).cleaning). Additional personal protective equipment or Additional personal protective equipment or

cleaning requirements may be required for cleaning requirements may be required for certain products.certain products.

ResponsibilitiesResponsibilities

All employees to follow this procedureAll employees to follow this procedure Quality Assurance & Management Quality Assurance & Management

responsible to ensure personnel follow this responsible to ensure personnel follow this procedure.procedure.

Employees are to report to their supervisor Employees are to report to their supervisor any need for uniform repair or any need for uniform repair or replacement.replacement.

Personnel hosting visitors must comply Personnel hosting visitors must comply with this procedure.with this procedure.

ReferencesReferences

GEN-002 Personnel Responsibilities in GEN-002 Personnel Responsibilities in Plant OperationsPlant Operations

SAF-008, Operation of the PAPR SAF-008, Operation of the PAPR (Powered Air Purifying Respiratory) Unit(Powered Air Purifying Respiratory) Unit

SAF-001, General SafetySAF-001, General Safety 21 CFR 211.28 Personnel Responsibilities21 CFR 211.28 Personnel Responsibilities

ProcedureProcedure

GMP Zones GMP Zones Detail the Detail the dress/gowning requirementsdress/gowning requirements, ,

environmental controls and frequency of environmental controls and frequency of cleaning.cleaning.

Unidirectional flow to prevent contamination & Unidirectional flow to prevent contamination & mix-ups.mix-ups.

Jewelry 7.2Jewelry 7.2

In product processing areasIn product processing areas NO [w]Wrist bracelets, watches and NO [w]Wrist bracelets, watches and

chains (necklaces)chains (necklaces) NO loose fitting or long dangling NO loose fitting or long dangling

earrings (except one-piece earring fitting earrings (except one-piece earring fitting under hairnets)under hairnets)

NO pins or other itemsNO pins or other items NO jewelry worn on uniformNO jewelry worn on uniform

One ring (band/small mounting) can One ring (band/small mounting) can be worn under gloves.be worn under gloves.

Other Items 7.3Other Items 7.3

Not Permitted in Manufacturing & Not Permitted in Manufacturing & Packaging areasPackaging areas No heavy make-upNo heavy make-up No false eyelashesNo false eyelashes No artificial fingernails (unless covered by No artificial fingernails (unless covered by

gloves)gloves)

General Guidance 7.5General Guidance 7.5

All special apparel must be worn properly All special apparel must be worn properly to ensure cleanliness & safetyto ensure cleanliness & safety No dress code for those wearing uniformNo dress code for those wearing uniform Non-uniformed employees dress to meet HR Non-uniformed employees dress to meet HR

dress requirementsdress requirements

Hygiene & Sanitation Practices Hygiene & Sanitation Practices 7.5.27.5.2

Always practice good practicesAlways practice good practices Wash hands with soap & warm water and dry Wash hands with soap & warm water and dry

thoroughly after use of restroom or when thoroughly after use of restroom or when hands are soiled.hands are soiled.

Avoid unsanitary practices/contaminationAvoid unsanitary practices/contamination• Scratching headScratching head• Wiping foreheadWiping forehead• Fingers in nose, mouth, earsFingers in nose, mouth, ears

Gowning Requirements 7.5.4Gowning Requirements 7.5.4

Applies to employees, visitors, & Applies to employees, visitors, & contractors. contractors.

Hair Covering 7.5.5Hair Covering 7.5.5

Must be worn at all times in Must be worn at all times in manufacturing, packaging and warehouse.manufacturing, packaging and warehouse.

Must cover as much hair as possibleMust cover as much hair as possible Long hair tuckedLong hair tucked Facial hair covered with beard coversFacial hair covered with beard covers

Applies to all employees and visitorsApplies to all employees and visitors

Safety Glasses 7.5.6Safety Glasses 7.5.6 Must be worn by all employees & Must be worn by all employees &

visitors enteringvisitors entering Designated Laboratory AreasDesignated Laboratory Areas Compression/Blending Manufacturing Compression/Blending Manufacturing

AreasAreas Designated packaging areas Designated packaging areas

(Dispensing)(Dispensing) Equipment WashroomsEquipment Washrooms

Note: Must also be worn while cleaning Note: Must also be worn while cleaning agents/chemicals or work with agents/chemicals or work with potential to cause eye injurypotential to cause eye injury

Uniform/Lab Coat 7.5.7Uniform/Lab Coat 7.5.7

Adequate number issued to ensure Adequate number issued to ensure cleanlinesscleanliness All buttons secured except collarAll buttons secured except collar Shirts tucked in trousers and rolled down & Shirts tucked in trousers and rolled down &

cuffs snapped.cuffs snapped.

Dedicated storage areas are providedDedicated storage areas are provided NOT worn outside facilities exceptNOT worn outside facilities except

Emergency evacuationEmergency evacuation Maintenance personnel traveling between Maintenance personnel traveling between

facilities facilities

Uniform/Lab Coat 7.5.9Uniform/Lab Coat 7.5.9

NOTE:NOTE: Office staff, management when traveling Office staff, management when traveling

between buildings – Carry lab coats over between buildings – Carry lab coats over forearm. Don when enter classified areas.forearm. Don when enter classified areas.

Employees in plant uniforms must wear lab Employees in plant uniforms must wear lab coats when traveling between buildings. coats when traveling between buildings. Remove prior to entering classified areaRemove prior to entering classified area

Hair net, beard cover, lab coats and Hair net, beard cover, lab coats and gloves must be removed prior to leaving gloves must be removed prior to leaving GMP zones.GMP zones.

General Information 7.5.10General Information 7.5.10

No personal clothing (including shoes) in No personal clothing (including shoes) in Manufacturing/Packaging areas unless Manufacturing/Packaging areas unless covered by lab coat (shoe covers).covered by lab coat (shoe covers).

Applies to personnel/visitors/contractorsApplies to personnel/visitors/contractors Soiled uniforms placed in designated Soiled uniforms placed in designated

areas for cleaning.areas for cleaning. Employees report need for repair or Employees report need for repair or

replacement of uniformreplacement of uniform

Shoes 7.15.13Shoes 7.15.13

All employees (Mfrg, Pkg, Whse, Lab) if not All employees (Mfrg, Pkg, Whse, Lab) if not wearing safety shoes must wear flat-heels, wearing safety shoes must wear flat-heels, closed toe (no sandals).closed toe (no sandals). Keep clean, [l]LacedKeep clean, [l]Laced Plant shoes not taken homePlant shoes not taken home

Shoe covers required on non-plant shoes – Shoe covers required on non-plant shoes – specified areas – Liquid Capsulespecified areas – Liquid Capsule

Approved Safety Shoes- required by Whse/Mtrl Approved Safety Shoes- required by Whse/Mtrl Hndlr/Maint/Custodial personnelHndlr/Maint/Custodial personnel

Gowning Requirements 7.6Gowning Requirements 7.6

EmployeesEmployees Clock-inClock-in Sanitize handsSanitize hands Security Check pointSecurity Check point

No [f]Food in gowning areas or in GMP No [f]Food in gowning areas or in GMP zones.zones. Store food in refrigerators before going to Store food in refrigerators before going to

gowning areasgowning areas• DO NOT CARRY FOOD IN WHSEDO NOT CARRY FOOD IN WHSE

Gowning Area Requirements Gowning Area Requirements 7.6.47.6.4

Warehouse, 1, 2, WIP AreasWarehouse, 1, 2, WIP Areas Uniform & Hair netUniform & Hair net Remove and discard hair net when leaving to Remove and discard hair net when leaving to

unclassified areaunclassified area WarehouseWarehouse

Uniform, Hair net and beard coverUniform, Hair net and beard cover Remove and discard hair net/beard covers Remove and discard hair net/beard covers

when leaving to unclassified areawhen leaving to unclassified area

Gowning Area Requirements Gowning Area Requirements 7.6.4.47.6.4.4

Manufacturing 1Manufacturing 1 Uniform, hair net, plant shoes/shoe Uniform, hair net, plant shoes/shoe

covers and beard covers.covers and beard covers.• Lab coat if not wearing uniformLab coat if not wearing uniform

Clean gloves appropriate for tasksClean gloves appropriate for tasks Remove and discard gloves before Remove and discard gloves before

entering gowning area.entering gowning area.• Remove lab coat, hair net and beard Remove lab coat, hair net and beard

cover (change uniform or de-dust)cover (change uniform or de-dust)• Exception for Maintenance personnelException for Maintenance personnel

Gowning Area Requirements Gowning Area Requirements 7.6.4.57.6.4.5

Packaging 2 & 3Packaging 2 & 3 Uniform, hair net, and beard cover Uniform, hair net, and beard cover

(lab coat when no uniform)(lab coat when no uniform) Direct contact with product and Direct contact with product and

packaging components require packaging components require appropriate gloves.appropriate gloves.

Remove and discard gloves before Remove and discard gloves before entering gowning areaentering gowning area• Remove lab coat, hair net and beard Remove lab coat, hair net and beard

cover before leaving gowning area. cover before leaving gowning area. Uniforms changed or de-dusted.Uniforms changed or de-dusted.

Gowning Area Requirements Gowning Area Requirements 7.77.7

Special Gowning Areas (HormonesSpecial Gowning Areas (Hormones Use Gowning airlock for controlled Use Gowning airlock for controlled

manufacturing suite areasmanufacturing suite areas• NO Food or drinkNO Food or drink• Enter airlock, close door and confirm door to Enter airlock, close door and confirm door to

manufacturing area is closedmanufacturing area is closed• Don protective suit (Tyvek) over uniform or loose Don protective suit (Tyvek) over uniform or loose

clothesclothes• Belt mounted PAPR & head hoodBelt mounted PAPR & head hood

PAPR Requirements 7.7.6PAPR Requirements 7.7.6

Complete respirator fit training and Complete respirator fit training and documentationdocumentation

Complete medical questionnaireComplete medical questionnaire Treatment authorization, Pass exam for Treatment authorization, Pass exam for

respiratory clearance.respiratory clearance. Two employees gowning (Buddy System)Two employees gowning (Buddy System)

Assist and confirm proper operation prior to Assist and confirm proper operation prior to entering areaentering area

PAPR Requirements 7.7.7PAPR Requirements 7.7.7

Prior to leaving the manufacturing areaPrior to leaving the manufacturing area Employees brush off each other (or walk thru blow Employees brush off each other (or walk thru blow

down unit) to remove excess product material.down unit) to remove excess product material. Remove and discard gloves before leaving gowning Remove and discard gloves before leaving gowning

airlocksairlocks Confirm entrance & exit doors are closedConfirm entrance & exit doors are closed Remove PAPR system and tyvek suitRemove PAPR system and tyvek suit

• Shower, dispose of suit if end of shiftShower, dispose of suit if end of shift No visitors in controlled manufacturing areas without No visitors in controlled manufacturing areas without

approval and proper trainingapproval and proper training