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Slide 1 © PharmOut 2017
Good Cleanroom Design & Construction Practice
Presented by Gordon Farquharson
July 2017
Slide 2 © 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.
Slide 3 © PharmOut 2017
ISO 14644-4 :2001 and NEW 2018
2001
• Adequate space.
• Specify ISO cleanliness class.
• Clean construction protocol.
• Avoid cracks, crevices, and uncleanable areas.
• Impervious, non-shedding surfaces.
• Coved junctions.
• Guidance on air changes/hr for non-UDF.
• Design review and testing fits with old Annex 15.
2018 new aspects
• Generally updated.
• Air change rates guidance removed; source strength of contaminants and ventilation effectiveness principles included.
• Energy saving measures identified.
• URS added to link to new Annex 15 PIC/S GMP guide.
Slide 4 © PharmOut 2017
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
BUTAll cleanrooms use common components and techniques
Slide 5 © PharmOut 2017
Cleanrooms are very different!
Cleanroom technology
applied to API manufacture
Slide 6 © PharmOut 2017
Cleanrooms are very different !
Formulation equipment
Slide 7 © PharmOut 2017
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.
Slide 8 © PharmOut 2017
Configuration of Clean Rooms
Slide 9 © PharmOut 2017
Design Layout
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.
Planning and layout requirements are not defined in GMPs or Cleanroom standards.
Slide 10 © PharmOut 2017
Don’t Underestimate the Impact of the Process Equipment
Slide 11 © PharmOut 2017
vacuum
heatingcooling
CIP/SIP
classified area
uncontrolled area
uncontrolled area
The Potential of Closed Process Equipment
Slide 12 © PharmOut 2017
Designing for Adaptability
Loose fit - enables changes with minimum disruption
Consider modular design
Clean construction protocol ISO 14644-4
External access for maintenance
Service chases
Slide 13 © PharmOut 2017
Corridors and Working Spaces
Slide 14 © PharmOut 2017
Remember Maintenance of Technical Systems
Slide 15 © PharmOut 2017
Some images from MRC Systems & Clestra
Construction of clean rooms
Slide 16 © PharmOut 2017
Basic Construction Methods
Finish options:
• Sheet PVC
• Sprayed elastomeric paint
• Epoxy paint
Masonry + gypsum applied plaster +
applied finish
Finish options:
• Sheet PVC
• Sprayed elastomeric paint
• Epoxy paint
Gypsum or calcium silicate board +
closing of joints + applied finish
• Mild steel painted
• Stainless steel
• GRP – Glass reinforced polyester
• Phenolic sheet
Options
GMP doesn’t mandate any specific approach.
1. “Stick-built”. In-situ construction
2. Pre-fabricated, pre-finished cleanroom wall & ceiling panel systems
Slide 17 © PharmOut 2017
Choosing the Preferred Option
• Shouldn’t always be at the top of the list.
• Remember you should be considering >20 years life.
Cost
• Materials
• Labour to install
• Technical support
Local sourcing
• Clean/dirty - Dry/wet
Construction environment
• Have to make decisions early for pre-fabricated
• Have longer to cogitate for stick-built
Project lead times and decision making
• Is the systems compatible with development and evolution of the business operations?
Modification and relocation requirements
• In house / Local resources
• Vendor dependent
Repair
Slide 18 © PharmOut 2017
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
Slide 19 © PharmOut 2017
Masonry System
Slide 20 © PharmOut 2017
• Masonry walls
• Concrete ceiling
• Hard plaster (gypsum)
• Door frames set into
the wall structure
• Applied epoxy paint to
walls
• Thin epoxy floor finish
Slide 21 © PharmOut 2017
Gypsum Board and Frame System
• Metal frame
• Calcium silicate or Gypsum board attached
• Joints taped
• Finish applied – this case a glass reinforced polyester resin.
Slide 22 © PharmOut 2017
GRP Cleanroom Panel SystemPicture courtesy of MRC Systems Ltd
Slide 23 © PharmOut 2017
Typical Metal Panel System
Slide 24 © PharmOut 2017
Floor Channels...
Slide 25 © PharmOut 2017
Ceiling Channels...
Slide 26 © PharmOut 2017
Walk-on Ceiling…
Slide 27 © PharmOut 2017
Single or Double Glazing…
Slide 28 © PharmOut 2017
Doors Swing Slide Powered…
Slide 29 © PharmOut 2017
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
Slide 30 © PharmOut 2017
Door Options
• Hinged
• Horizontal sliding
• Vertical roller door
Slide 31 © PharmOut 2017
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.
Slide 32 © PharmOut 2017
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
Slide 33 © PharmOut 2017
Doors in OSD Application-With Airlock
+
+++
Process Room
+
Clean process corridor ++
+++
Process Room
+
Slide 34 © PharmOut 2017
Doors in OSD Application – Without Airlock
34
Process Room
+
Clean process corridor ++
Process Room
+
Slide 35 © PharmOut 2017
Sliding Doors in OSD Cleanroom
Example MSD Singapore
Slide 36 © PharmOut 2017
Sliding Door Details
Very important to choose specialist good supplier.
Essential Top track, door leaf, and bottom guide.
Slide 37 © PharmOut 2017
Single Door Width
Slide 38 © PharmOut 2017
Insulated Sliding Doors – Cold Room
Slide 39 © PharmOut 2017
GRP Sliding Doors
Slide 40 © PharmOut 2017
Glass & Low Leakage Sliding Doors
Slide 41 © PharmOut 2017
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
Slide 42 © PharmOut 2017
Cleanroom Flooring (1)
• PVC sheet (lowest cost)
– Adhered to floor.
– Seams welded
– Cove former to walls
• Tacky mats
– Permanent
– Peel-off
Sheet materials adhered to floor:
Slide 43 © PharmOut 2017
Cleanroom Flooring (2)
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
Applied screeds
Slide 44 © PharmOut 2017
Cleanroom Flooring (3)
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.
Cleaning
Slide 45 © PharmOut 2017
Equipment Integration
• Space for the equipment.
• Integration with the room fabric.
• Maintenance access.
• Room Pressure barriers.
Slide 46 © PharmOut 2017
Equipment Integration
• Room Pressure barriers.
• Impact of equipment on room pressure due to air in-flow (loss) into the equipment.
Slide 47 © PharmOut 2017
Thank you for your time.Questions?
Gordon Farquharson
www.pharmout.net
Executive Consultant