cleanroom training

7/26/2019 Cleanroom Training

1/21

Your Cleanroom --

A Workshop

Mary Taylor

Micronova Manufacturing


2/21

Controlled Environments

Air Flow Control

Gowning Control Regimented Cleaning

Particle control and monitoring

Bioburden control and monitoring


3/21

Room Classifications Historic -- Mil Std 209

ISO

FDA

EU

Harmonization


4/21

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)


5/21

The Cleanest Areas

Bio Tech: ISO 5, GradeA (was Class 100)

Aseptic/Sterile Core

Filling Suites

Cell Culture (BioHoods)

Full Gowning:shoe cover, gloves,

hair cover, beardcovers, coveralls,hood, aseptic:goggles, sterilemask, 2nd pair ofsterile gloves.

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


6/21

Clean Areas ISO 7, 8 & Non-classifed, 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, DGowning: frock/coverall, shoe cover, hair cover,

beard cover, gloves, face mask

Former Class 10,000 =

ISO 7: 0.5 micron 352,0000Grade 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


7/21

Cleanroom Priorities

Air Exchanges

Cleaning

Gowning Material Transport

Activity Flow


8/21

Air Flow

16


9/21

Cleaning & Sanitizing

Plan -- Cleanest to Dirtiest

Validated & Standard Practices

When in use Between uses

Disinfectants vs. Detergents

Documentation Training


10/21

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?


11/21

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


12/21

Cleaning Strategy

When do we clean what?

Typically clean floors and work surfaceswhen in use, walls less frequently, ceilings

less oftenAseptic 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?


13/21

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 aftershutdowns

Gown rooms ~~ Floors daily

Non-classified, bioburden control ~~Floors daily


14/21

Double Bucket System:

The Bio Pharma Standard Clean and dirtybuckets

Disinfectant in each

bucket

Increased area forcleaning 1000square feet for ISO 7

and 8 areas


15/21

ISO Validated Methods:

Floors Pull and Lift overlapping strokes

(string type or sponge type floor mops)

Modified Figure 8 method (string mops)


16/21

ISO Validated Methods Horizontal (walls) overlapping strokes

Vertical (walls)

ISO methods, the FDA standard.


17/21

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 withdisinfectants

Tools: Durable, non-reactive vs. non-reactive,autoclavable, compatible with disinfectants


18/21

Environmental Monitoring

Particles

Bioburden

Alert/Action Limits Challenges


19/21

References

FDA -- CDER, CBER

ISO

ISEP IEST

USP

Suppliers


20/21

Keeping it Clean

Adequateair flow

Cleaning

schedule Controlmaterialsand peopleenteringclean area

Appropriategowning

Product,activity flow


21/21

Next steps:

What are we doing now?

What could we be doing Techniques

Frequency

Tools, Materials

What will we implement?

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