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Your Cleanroom -A Workshop

Mary Taylor
Micronova Manufacturing

Controlled Environments
Air Flow Control Gowning Control Regimented Cleaning Particle control and monitoring Bioburden control and monitoring

Room Classifications
Historic -- Mil Std 209 ISO FDA EU Harmonization

Cleanroom Classifications
Class 10 ~ ISO 4 Class 100 ~ ISO 5, may be Aseptic, EU: A Class 1000 ~ ISO 6, may be Aseptic, EU:A or B Class 10000 ~ ISO 7, EU: B or C Class 100,000 ~ ISO 8, D ISO 9 Non-classified (may be a clean as ISO 7)

The Cleanest Areas


Bio Tech: ISO 5, Grade A (was Class 100)
Aseptic/Sterile Core Filling Suites Cell Culture (Bio Hoods)

Specifications
ISO 5: >0.5 micron 3,520 Grade A: 0.5 micron 3,500 in operation & at rest FDA 100: ISO 5, 1 cfu

Full Gowning: shoe cover, gloves, hair cover, beard covers, coveralls, hood, aseptic: goggles, sterile mask, 2nd pair of sterile gloves.

Clean Areas ISO 7, 8 & Nonclassifed, Bioburden control


Formerly Class 10,000 and 100,000 Area adjacent to sterile fill -- Grade B Cell Culture, Buffer and Media Preparation, Compounding, Fermentation, Formulation can be ISO 7, 8 or unclassified. Grade C, D
Gowning: frock/coverall, shoe cover, hair cover, beard cover, gloves, face mask

Former Class 10,000 = ISO 7: 0.5 micron 352,0000 Grade B: 3,500 at rest; 350,000 in operation Grade C: 350,000 at rest; 3,500,000 in operation FDA: ISO 7, 352,000; 10 cfu

Cleanroom Priorities
Air Exchanges Cleaning Gowning Material Transport Activity Flow

Air Flow

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Cleaning & Sanitizing


Plan -- Cleanest to Dirtiest Validated & Standard Practices When in use Between uses Disinfectants vs. Detergents Documentation Training

Cleaning Strategy
What do we clean in what order?

Clean from cleanest to dirtiest


Where are the HEPAs? What is traffic flow? the exit door? Where are air return vents? Product contact surfaces? What stays in cleanroom?

Cleaning Strategy How do we clean what?


Use the validated methods and standard practices.

Double bucket Overlapping strokes Floors Lift and pull, Modified Figure 8 Walls Horizontal, Vertical Strokes Surfaces Ceilings

Cleaning Strategy When do we clean what?


Typically clean floors and work surfaces when in use, walls less frequently, ceilings less often
Aseptic walls and floors daily, ceilings maybe
less What are the room classifications? How busy is the area, people, equipment? What is air flow, number of HEPAs? Does the area get dirty, dusty, contaminated? How do the surfaces appear?

Common Frequencies
by classification when in use

ISO 4/5 ~~ Floors, walls, ceilings daily ISO 7 ~~ Floors daily, walls weekly, ceilings monthly ISO 8/9 ~~ Floors daily (+), walls monthly, ceilings quarterly, or after shutdowns Gown rooms ~~ Floors daily Non-classified, bioburden control ~~ Floors daily

Double Bucket System: The Bio Pharma Standard


Clean and dirty buckets Disinfectant in each bucket Increased area for cleaning 1000 square feet for ISO 7 and 8 areas

ISO Validated Methods: Floors


Pull and Lift overlapping strokes (string type or sponge type floor mops) Modified Figure 8 method (string mops)

ISO Validated Methods


Horizontal (walls) overlapping strokes Vertical (walls) ISO methods, the FDA standard.

Cleaning Strategy Other considerations


Clean and/or Disinfect
Detergents vs. Disinfectants Quick drying vs. Wet for 10 to 15 minutes Materials: Low Linting, Low particles, autoclavable or sterile, compatible with disinfectants Tools: Durable, non-reactive vs. non-reactive, autoclavable, compatible with disinfectants

Environmental Monitoring
Particles Bioburden Alert/Action Limits Challenges

References
FDA -- CDER, CBER ISO ISEP IEST USP Suppliers

Keeping it Clean
Adequate air flow Cleaning schedule Control materials and people entering clean area Appropriate gowning Product, activity flow

Next steps:
What are we doing now? What could we be doing
Techniques Frequency Tools, Materials

What will we implement?

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