Insights f s from om a a For ormer FD FDA Representat ative - - PowerPoint PPT Presentation

Insights f s from

• m a

a For

• rmer FD

FDA Representat ative ve

Kris Evans, Executive Director, Quality Sciences Amgen, Inc.

Introduction / Background

• US Food and Drug Administration
• Twenty (20) years as a Field Investigator and later in CDER’s Office of Compliance on

the Guidance and Policy Team

• Conducted biopharmaceutical inspections worldwide, specializing in sterile

manufacturing operations

• Authored FDA GMP guidance and policy documents on sterilization and validation,

including FDA Aseptic Processing Guidance

• PDA Science Advisory Board and has been an active contributor to several PDA

Technical Reports

• Amgen, Inc.
• Executive Director of Quality Sciences - Ensures Amgen is science- and risk-based in

their quality activities

• Aseptic Processing: Operating Standards, Aseptic Council, Aseptic Behavior Program

Aseptic Behavior Program

Aseptic Behaviors Training

Subject Matter Experts

Oversight

Aseptic Council

Human Performance Tools

Metrics

Aseptic Processing Behaviors

Move Slowly and Deliberately Protect Sterility of Equipment, Components and Product Maintain Gowning Control Be Aware of Body Positioning Practice Good Hygiene

Move Slowly and Deliberately

• Think before acting.
• Quick and sudden movements can create turbulence in Grade 5

areas.

• Such movements disrupt the unidirectional airflow, presenting a

challenge beyond design and control parameters.

• Keep unnecessary movement to a minimum and when not

performing tasks, stand or sit still, with hands up and above waist level.

New Aseptic Technologies - Isolators

• Barrier between exposed product contact

surfaces and Operators

• Utilizing physical barriers, gloves, filters and

differential pressure

• Integrity test of isolator and gloves
• Sporicidal decontamination of chamber
• Including cleaning and disinfection of the

surfaces

• Everything that enters a decontaminated

chamber is sterile

Potential Benefits of an Isolator

• Environmental Monitoring (Viable)
• Should be reduced (significantly) with excellent data history
• Media Fills
• Length of Campaign more important than Personnel
• Smoke Studies
• Turbulent air may not be a significant concern
• Training
• Aseptic Behavior is still important; however, interventions are probably not

the most important training objective

Back-up Slides

Protect Sterility of Equipment, Components and Product

• Perform all operations, and interventions, exactly per procedure.
• Personnel must never directly contact sterile product, containers,

closures, or unprotected critical surfaces with any part of their gown

• r gloves.
• Between uses, sterile instruments must be held within the Grade 5

barrier area and maintained in a manner to prevent contamination.

• Operators must refrain from unnecessary talking. If required, talking

must take place away from the critical area and open product or containers.

Maintain Gowning Control

• Complete gowning according to the established procedure.
• Ensure gown packages are integral before opening.
• Gowns must fit properly (not too big, not too small), with overlapping

areas that prevent skin exposure at all times within the aseptic core.

• During gowning and throughout operations, avoid contact with floors,

wall, equipment and other personnel.

• Entire glove and wrist area must be sanitized before and after

touching a surface.

• Gloves must be immediately replaced if torn or damaged.

Be Aware of Body Positioning

• Use “First Pass Air” concepts to ensure that HEPA-filtered,

unidirectional air always flows first over sterile equipment surfaces, components, closures, and product without contacting non-sterile surfaces.

• The operator’s body must be maintained away from the Critical Area.
• Barrier doors must remain closed, unless required to perform an
• intervention. If an intervention requiring operator proximity to sterile

surfaces or components is needed, procedures must be followed including clearance, sanitization and sampling.

Practice Good Personal Hygiene

• Must be free from respiratory conditions, skin conditions (including

sunburns and flaking skin), and any infectious disease.

• Hands, hair, and nails must be clean and healthy to prevent potential

contamination.

• Wash hands using the established method prior to gowning into the

classified area.

• Jewelry and cosmetics are not worn in manufacturing areas.