Modular Cleanrooms and Facility Design Presentation

Modular Cleanrooms and Facility Design Presentation

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 >Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30

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