Presentation at the Cleanroom Technology Conference 2020 by George Walker, Associate Director, Ardmac.
Application and use of modular
cleanrooms and facility design in
line with current manufacturing
trends Presented By: George Walker
Agenda
• Challenges faced by Pharma companies
• Manufacturing Trends affecting facility design
• Applications of Modular build for cleanrooms
• What's the future look like for cleanroom design
• Summary
Challenges faced by
Pharma companies
Today's challenges in Pharma
• Changes in global demographics increasing demands for medicines • Continued pressure to reduce healthcare costs • New modalities expanding product pipelines • Getting new drugs to market quickly
Meeting those challenges
• Need for Innovation & collaboration R&D, Regulatory (RMAT) • Faster development pathway to operational readiness • Predictability on cost and programme • Efficiency to reduce cost for both CAPEX and OPEX
New Manufacturing
Trends
Manufacturing for the Pharma market
• Single Use Technology - SUT
• Conti - continuous manufacturing
• Flexible, Decentralised facilities
• Closed process vs open
• Low volumes driving Scale Out for ATMP’s
• Increased use in robotics
• Commercial realisation of small batches
Impacts on facility design
• Ballroom cleanroom concept • Downgrading level of cleanroom classification • Reduced cleanroom footprint • Small manufacturing facilities with ability to scale • Box in Box model proliferation • Multimodal facilities meeting the demand for multi-product manufacturing • Requirement for Agile manufacturing facility
Developments in
Modular Cleanroom
Solutions
History of modularisation
• OEM Skids – 1980’s • Traditional Process Skids – 1990’s • Residential – mid 1990’s • Cleanroom panel systems – mid 1990's • Pre-fabricated production facilities – 2000’s • Pre-fabricated Schools – late 2000’s • Buildoffsite 2010's • Modular Pods 2010's • Standard integrated platforms – 2018 +
Images courtesy of Exyte
MONOBLOC SOLUTION
BI-PANEL SOLUTIONS
BENEFITS: • Fully Demountable • Flexible solutions • For an Agile facility
• Unlimited service voids • Interchangeable Panels • Parallel construction • Easily Reconfigured • Accessible Services
BI-PANEL CEILINGS
• Twin Cassette ceiling system giving multi directional cable management • 2.5kn/m² loadings • Allows for Parallel construction • Advanced material ordering due to modular configuration
• Integrated modular lights and HVAC • Interchangeable ceiling tiles & services
Modular Facility Options
• Cellular Design (Box in Box) • Fully Autonomous POD’s • Cleanroom Structural modules (int + ext) • Mobile Cleanroom facilities
Integrated Modular Solutions
• Germfree BioGo • G-Con
• ICON by IPS & G-Con • Slatexspace by CRB • Exycell by Exyte • GE KUBio
Offsite Sub-Assemblies
• Standardised design of Ceiling Modules & serviced Partition Skids
• FAT, Factory assembled modules
• Modules based on • Flat pack ceiling modules c/w integrated services • Skid mounted partitions c/w Utility plates, Safe change & ducting
• Standardised CR-RCU (1.6m3/s)
• Manufacturing / subassembly
Pre-Assembled Ceiling Modules
• Module size 5m x 2.1m
• Aluminium honeycomb 60mm thick panels
• Preinstalled Lights and small services
• Openings formed for Terminal HEPA housings
• Pre-assembled Ceiling Mounted Utility Panel
• Uni directional Grid for Cable Management
Pre-Assembled Partition Skid Modules
• 200mm infill Service Mullion positioned between each partition skid
HVAC Airflow Concept
• Standard CR-RCU Concept • Repeated Design • Integrated Controls on all HVAC Equipment
CR-RCU’s
Key Features:
• Integrated factory tested Control System Fan options to achieved A+ Rating (Interchangeable for future)
• Integrated CAV & VAV’s
• Standard Frame Size
• Common Components to all units
• Full Fresh and Re-Circ Versions
• Minimal on site install and commissioning
Module Assembly - Electrical
• All electrical containment integrated with docking station
• Home run cable to go from individual modules to dedicated distribution board with plug and play connections • Pre Tested cabling to reduce on site commissioning and testing time
• Complete flexibility for alterations
with
Ductwork Assembly
Push Fit Ductwork Connections • Fittings and ducts are manufactured from zinc coated sheet metal • Other material than galvanised can also be supplied, for example • Stainless steel • Aluminium • Plastic Coated Products • Aluzink
Corrosive category
Sheet metal material
C3 C4
Galvanized steel sheet metal Z 275
Aluminium sheet metal Plastic HB-polyester coated galvanised steel sheet metal Plastic epoxi+PE-painted galvanized steel sheet metal Aluzink sheet metal AZ 185
C5
Stainless steel sheet metal
Tempered CHW
CHW skid & distribution
• Package unit is mounted on a fabricated stainless steel support base with interconnecting pipework
• Power supply is typically 400V, 3 phase, 50Hz, 10 Amp
• Skid fully 3D modelled available for BIM requirements.
• Fully assembled and tested off site (FAT) and ready to install • Integrated dosing pot, expansion vessel, fill sets, heat meters, duty/standby pumps • Control panel, featuring touch screen with access to all system parameters and energy data. Remote access and retransmission possible • Piped distribution loop connects to CR-RCU’s, providing sensible cooling for the dry coil concept. Controlled locally at CR-RCU
What does the
future look like for
Cleanroom Design
Future Trends
• Downward pressure on pricing
• From treatment to prevention
• ATMP’s are changing the face of production facilities
• Manufacturing 4.0
Summary
• The Pharma sector is going through a monumental change
• Modular Cleanroom designs will play a large role in meeting our Pharma clients needs now and, in the future • Advancements in Modular solutions are keeping pace with this change and are important in meeting those challenges • With programme, cost and quality certainty, modular solutions are proving attractive to many Pharma manufacturers
Conclusions
• Collaborative approach to design of facilities is becoming even more important in the delivery of the Cleanroom of the future. • Flexible, agile and standardised solutions have a large role to play in providing solutions • The use of innovative technologies and smart design will provide lean efficient process and enable rapid decision making
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