fabric & finishes
Post on 07-Nov-2021
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Slide 2 © PharmOut 2017
Every Cleanroom is a “Prototype” !!
• Process & Product has unique features
• The building and its environment are unique
• The equipment configuration is unique
• The project team is unique
BUT
All cleanrooms use common components and techniques
Slide 3 © PharmOut 2017
Cleanrooms are very different!
Cleanroom technology
applied to API manufacture
Slide 5 © PharmOut 2017
Role of the Cleanroom 1
1. Exclusion of the external environment.
2. To create the class of cleanliness 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 Personnel flow and procedures by way of planning and layout of the suite.
Way IN ==> Way Out.
Slide 6 © PharmOut 2017
Role of the Cleanroom 2
Role Control and management of Material flow by way of planning and layout of the suite.
To create optimum conditions for the process, including special requirements such as Low %RH; special illumination conditions; etc.
To accommodate the process equipment in a safe and effective way.
To allow effective monitoring of the controlled environment created in the cleanroom suite.
Slide 8 © 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.
Slide 10 © PharmOut 2017
vacuum
heatingcooling
CIP/SIP
classified area
uncontrolled area
uncontrolled area
The potential of closed process equipment
Slide 11 © 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 12 © PharmOut 2017
Loose Fit Design Concepts Service Zone Concept Plan
Process
Area“B”
Unclassified Technical Support Area
Process Corridor “B”
Slide 13 © PharmOut 2017
Loose Fit Design Concepts Service Chase Concept Plan - Microelectronics
Unclassified Technical Support Area
Process
Area“B”
Process Corridor “B”
Slide 17 © 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 systems
Slide 18 © 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 19 © 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 21 © 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 22 © 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 30 © PharmOut 2017
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 33 © 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 34 © 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 35 © 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
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