Good Cleanroom Design

& Construction Practice

Presented by Gordon Farquharson

July 2017

Slide 1 © PharmOut 2017

Agenda

Good Design & Construction Practice

– Cleanrooms
• Based on the scope and intents of the
revised edition of ISO 14644-4 “Design,
Construction & Start-up” due in 2018.
• ISO Link to Annex 15 of the PIC/S GMP
Guide.
• Some new energy saving considerations.
• Practical tips – the devil is in the details.

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ISO 14644-4 :2001 and NEW 2018

2001 2018 new aspects

• Adequate space. • Generally updated.
• Specify ISO cleanliness • Air change rates
class. guidance removed;
• Clean construction source strength of
protocol. contaminants and
ventilation effectiveness
• Avoid cracks, crevices, and
principles included.
uncleanable areas.
• Energy saving measures
• Impervious, non-shedding
identified.
surfaces.
• URS added to link to
• Coved junctions.
new Annex 15 PIC/S
• Guidance on air GMP guide.
changes/hr for non-UDF.
• Design review and testing
fits with old Annex 15.

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Every Cleanroom is a “Prototype” !!

• Process & Product has unique features

• The host building and its environment are
unique
• The equipment configuration and layout is
unique
• The project team is unique
BUT
All cleanrooms use common components and
techniques

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Cleanrooms are very different!

Cleanroom
technology
applied to API
manufacture

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Cleanrooms are very different !

Formulation
equipment

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Role of the Cleanroom 1

1. Exclusion of the external environment.

2. To create the class of cleanliness and environmental
conditions required for the process by dilution or
displacement of the contamination generated.
• To maintain ISO cleanliness Classes (1-9), or GMP
Grades (A-D).
3. Containment of hazards arising from the process.
4. Control of Process-to-Process cross-contamination. A
Pharma GMP issue.
5. Control and management of Material & Personnel
flows and procedures by way of planning and layout
of the suite.
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 Configuration of Clean
Rooms

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Design Layout
Planning and layout requirements are not defined
in GMPs or Cleanroom standards.

The expectation however, is quite clear. The layout and

planning should ensure the following:

1. Effective segregation between the external

environment and the classified space.
2. Well managed materials and personnel flow.
3. Segregation spaces of different grade or class.

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Don’t Underestimate the Impact of the
Process Equipment

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The Potential of Closed Process
Equipment
CIP/SIP
vacuum
classified area

uncontrolled area

heating
cooling

uncontrolled area

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Designing for Adaptability

Loose fit - enables changes with minimum

disruption

Service
Consider modular design chases

Clean construction External access

protocol ISO 14644-4 for maintenance

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Corridors and Working Spaces

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Remember Maintenance of Technical
Systems

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 Construction of clean rooms

Some images from MRC Systems & Clestra

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Basic Construction Methods
GMP doesn’t mandate any specific approach.

1. “Stick-built”. In-situ construction

Masonry + gypsum Finish options:

applied plaster + • Sheet PVC
applied finish • Sprayed elastomeric paint
• Epoxy paint

Gypsum or calcium Finish options:

silicate board + • Sheet PVC
closing of joints + • Sprayed elastomeric paint
applied finish • Epoxy paint

2. Pre-fabricated, pre-finished cleanroom wall & ceiling panel systems

• Mild steel painted

• Stainless steel
Options
• GRP – Glass reinforced polyester
• Phenolic sheet
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Choosing the Preferred Option
Cost
• Shouldn’t always be at the top of the list.
• Remember you should be considering >20 years life.

Local sourcing
• Materials
• Labour to install
• Technical support

Construction environment
• Clean/dirty - Dry/wet

Project lead times and decision making

• Have to make decisions early for pre-fabricated
• Have longer to cogitate for stick-built

Modification and relocation requirements

• Is the systems compatible with development and evolution of
the business operations?

Repair
• In house / Local resources
• Vendor dependent
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Other Attributes of The Construction
System
Ceiling:
• Suspended
• Bridging on walls
• Walk-on

Low level return air ducts:

• In wall construction
• Double wall required
• Plant on surface

Services in walls:
• In wall thickness
• In a service pod on wall
• In a service chase

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Masonry System

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 • Masonry walls

• Concrete ceiling

• Hard plaster (gypsum)

• Door frames set into

the wall structure

• Applied epoxy paint to

walls

• Thin epoxy floor finish

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Gypsum Board and Frame System
• Metal frame
• Calcium silicate or Gypsum board attached
• Joints taped
• Finish applied – this case a glass reinforced
polyester resin.

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GRP Cleanroom Panel System
Picture courtesy of MRC Systems Ltd

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Typical Metal Panel System

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Floor Channels...

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Ceiling Channels...

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Walk-on Ceiling…

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Single or Double Glazing…

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Doors Swing Slide Powered…

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Requirements - Door Attributes

1. Swing doors should close with air pressure.

2. Often need to work with electromechanical interlock systems
3. Doors should be self closing (soft close to avoid pressure
shocks).
4. Hygienic design. Avoid cavities and ledges.
5. Powered doors
• Becoming more common
• Ensures optimum open/close rate
• Can help avoid hand contact
6. Sliding doors
• OK
• Ensure cleanroom style
• Avoid floor tracks
• Ensure top track cleanable

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Door Options

• Hinged
• Horizontal sliding
• Vertical roller door

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Advantages of Sliding Doors

• Saves space (in particular in clean corridors for Grade C & D

areas).
• No wind effect when opening & closing.
• More convenient for moving materials & equipment (pallets,
IBCs).
• Less susceptible to
mechanical damage.
• More convenient for
large openings.
• Can be part opened.

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Disadvantages of Sliding Doors

• Sometimes greater cost than double leaf

swing door.
• Top track needs periodic inspection.
• Not good for dusty rooms – should be on
clean corridor side.

© FactoryTalk 2015 10-May-15

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Doors in OSD Application
-With Airlock

Clean process corridor

++

+
+
++ +
+
+
Process Process
Room Room
+ +

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Doors in OSD Application
– Without Airlock

Clean process corridor

++

Process Process
Room Room
+ +

34
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Sliding Doors in OSD Cleanroom

Example MSD Singapore

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Sliding Door Details

 Very important to choose

specialist good supplier.
 Essential Top track, door
leaf, and bottom guide.

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Single Door Width

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Insulated Sliding Doors – Cold
Room

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GRP Sliding Doors

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Glass & Low Leakage Sliding Doors

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Door Leakage
• Generally some leakage is OK.
• Should be estimated and allowed for.
• If cleanrooms are too airtight, pressure balancing and
pressure stability become problematic.
• Example – SP 30 +/-3 Pa

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Cleanroom Flooring (1)

Sheet materials adhered to floor:

• PVC sheet (lowest cost)

– Adhered to floor.
– Seams welded
– Cove former to walls
• Tacky mats
– Permanent
– Peel-off

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Cleanroom Flooring (2)

Applied screeds
1. Epoxy (thin self levelling)
• Available in ESD/static dissipative and conductive versions.
2. Polyurethane (thin self levelling)
• Some uses the natural power of silver to fight bacteria, and
• Available in ESD/static dissipative and conductive versions.
3. Epoxy terrazzo (thick)
• recycled granular material.
4. Tiles
• Ceramic (chemical plants)
• Epoxy
• Terrazzo

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Cleanroom Flooring (3)

Cleaning

1. Classified cleanrooms
• Surface swabbing with mops and controlled disinfectant
materials.
• Routine hygiene and cleanliness monitoring
2. Non-sterile manufacturing
• Machine cleaning preferred
• Periodic housekeeping controls.

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Equipment Integration

• Space for the equipment.

• Integration with the room fabric.
• Maintenance access.
• Room Pressure barriers.
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Equipment Integration

• Room Pressure barriers.

• Impact of equipment on room pressure due to air in-flow (loss) into
the equipment.

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Thank you for your time.
Questions?

Gordon Farquharson
[Link]

[Link]@[Link]
Executive Consultant

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