Autonomous Cleanroom PODs™
flexible, scalable, and mobile processing solutions
Designing the Future
of Biopharmaceutical Processing
True Facility Flexibility Providing Fast, Scalable,
Comprehensive Cleanroom and Containment Solutions
G-CON PODs™ offer a solution that reduces budget and
Autonomous Cleanroom PODs™
facility constraints by providing readily deployable, mobile,
scalable, and fully self-contained cleanrooms. G-CON
Manufacturing is equipped with the resources and experience to transform the industry by providing unmatched
manufacturing flexibility with a growing product portfolio,
including standard PODs™, miniPODs™, Transmissible Disease Containment (TDC)PODs™, and the megaPOD™.
Process Equipment & Electronics Integration
 Use of control PLC’s
POD™ Design Features
 Independent fire suppres-
 Robust aluminum con-
that are fully com-
sion system
struction
patible with Factory
 Ample working space for
 Drip-free quick connects
Talk and other pro-
for utilities, like water &
cess management
electricity
software
pieces of process equip-
 Plug and play option due
 PAT connectivity for
to air bearings, which
data storage and
process control
 On board controllers integrate mechanical systems with
process & building management systems
multiple personnel
 Can accommodate large
ment
 Dual POD™ configuration
makes it easy to move
doubles cleanroom area
the POD™ around
and allows for easy trans-
 Flexibility in designs utiliz-
ing our engineering & design partners
portation
 PODs™ can be sanitized
using VHP decontamination
Failsafe HVAC Systems On Board
 Automatic failover for
continuous operation
 Mechanical systems are
 Easy to service and main-
tain
 Cleanroom classifications
accessed from the ‘gray
of ISO 5-8 available or
space’
containment options of
BSL 1-3
 Compact ductwork to
avoid leaks and energy
losses
 BIBO HEPA filter system
Gown-in | Gown-out & Equipment Airlock
 Provides control for personnel flow at each POD™
 Optional without Gown-in | Gown-out, adds an addi-
tional square footage to the POD™ working area
Standard POD™ Dimensions
9’W x 42’L x 11.5’H
234 Sq. Ft. Cleanroom Area
(2.74m x 12.80m x 3.51m)
(21.8 Sq. Meters)
12’W x 42’L x 11.5’H
312 Sq. Ft. Cleanroom Area
(3.66m x 12.80m x 3.51m)
(29.0 Sq. Meters)
18’W x 42’L x 11.5’H
468 Sq. Ft. Cleanroom Area
(5.49m x 12.80m x 3.51m)
(43.5 Sq. Meters)
24’W x 42’L x 11.5’H
624 Sq. Ft. Cleanroom Area
(7.32m x 12.80m x 3.51m)
(58.0 Sq. Meters)
* POD cleanroom area w/ Gown-in|Gown-out / equipment airlock
*Customized systems are available
POD™ Product Portfolio
Standard POD · miniPOD· TDC POD· UnitOp PODs™
Established in:
Analytical/ Microbial Laboratory
 Therapeutic vaccine
 Lab infrastructure
 mAb (single and multi-
 Fill finish
product processes)
 OEM ready to use
 OSD
 Transmissible disease
 Personalized medicine
containment
Personalized Medicine/ PCR Laboratory
Benefit Case
 Scaling without inter-
ruption
9’W x 25’L x 11.5’H
≥100 Sq. Ft. Cleanroom Area
(2.74m x 7.62m x 3.51m)
(10.0 Sq. Meters)
9’W x 42’L x 11.5’H
≥230 Sq. Ft. Cleanroom Area
(2.74m x 12.8m x 3.51m)
(23.0 Sq. Meters)
and corridor incorpo-
9’W x 50’L x 11.5’H
≥300 Sq. Ft. Cleanroom Area
rated
(2.74m x 15.24m x 3.51m)
(30.0 Sq. Meters)
 Opportunity to delay
time to investment
 Unidirectional flow
Dimensions
9’W x 50’L x 11.5’H
≥300Sq. Ft. Cleanroom Area
(2.74m x 15.24m x 3.51m)
(21.8 Sq. Meters)
Unit Operation
Single-use Unit Operations
 Can be outfitted with
single-use equipment or
Transmissible Disease Containment
unit operations

Benefit Case
Rapid design and deployment
 Fast deployment
 Containment with redundancy functions
 Integrated decontamination methodologies

Rapid process flow
connectivity
available for proper sanitization and repeated
use
Dimensions
8.5’W x 50’L x 11.5’H
≥ 250 Sq. Ft. Patient Area
(2.59m x 15.24m x 3.51m)
(≥ 23.2 Sq. Meters)
Designing the Future
of Biopharmaceutical Processing
POD™ Facility Platforms
MONOCLONAL ANTIBODY · PERSONALIZED MEDICINE · CELL-BASED VACCINE
RECOMBINANT PROTEIN· AUTOLOGOUS VACCINE
G-CON and their A&E partners provide PODified facility platform solutions which are designed to meet customer requirements. PODs™ are constructed with the flexibility to be easily relocated or repurposed for the next drug product release or
alternative applications. PODs™ can be placed in an existing warehouse space or brown/greenfield site, allowing for easy
facility expansion or cloning of facilities in multiple locations for fast track facility build-up .
Conceptual 2,000L Monoclonal Antibody Facility
PODified Single-Use mAb
Production Facility
 Rapid construction period < than
18 months
 Lower cost of capital
 Ability to use pre-existing space
 Easily expandable
 Processes modification with high
flexibility
 Capable of multi-product campaigns per year
Conceptual Single Use Cell-Based Vaccine Facility
PODified Single-Use Cell-Based
Vaccine Facility
 Rapid deployment of capacity
demand
 Robust containment and BSL 1 to
BSL 2+ segregation
 Ease of up and down scalability
 Lower total project costs
Designing the Future
of Biopharmaceutical Processing
PODs™™ - Realized Process Opportunities
Design Features

Mobile – All PODs™ come equipped with air bearings and crane hookups for transport and installation

Reusable – PODs™ can be easily re-commissioned for a different project or application

Durable – All aluminum construction for extreme corrosion-free operating life and unequivocal robustness

Decontamination – PODs™ can undergo VHP decontamination or other gassing strategies, allowing for quick turnover
between campaigns and quick decontamination in the event of a containment issue

Energy efficient – PODs™ can be configured to re-utilize conditioned air from the clean space and do not comprise
of excessive ductwork
Integrated Utilities

HVAC – fully failsafe with automatic failover for continuous worry-free use

Information Technology (IT) hardware – control PLCs plus a 14-port switch for direct interface of process equipment
and HVAC data output

On board fire prevention – fire suppression system suppresses fires and communicates with any BMS

Utilities connections – zero drip quick connects for connection to water and electricity. No additional wiring needed

Process piping – cGMP process piping can be integrated based on customer requirements
Built-in Qualification

Documentation Commissioning – engineering turnover package included with each unit

Factory acceptance testing prior to delivery

Validation and qualification provided by our partnering firm
Costs Reduction

Opportunity cost – Other methods interrupt operations

Floor construction (poured epoxy floors included in every POD)

Integration of building utility systems and processes in a step by step mode

On-site construction management
POD™ Benefits

Lower cost of growth

On demand scalability

Requires only “gray space”

Enables fast-track construction

Fraction of the cost of traditional builds

PODs™ arrive commissioned with a compliant engineering turnover package

Predictable cost & timeline

Ideal for multiple applications and process technologies

Repurposable after product life cycle expiry
Process Features

Integration of single-use systems, unit operations or processes

Standardized hardware equipped with flexible pre-sterilized process systems

Options for pre-engineered solutions, for example fill/finish

Implementation of compact processing designs
Designing the Future
of Biopharmaceutical Processing
POD™ Applications
The flexibility and PODularity of self-contained PODs™ creates a variety of choices on how to utilize the PODs™ to its best purposes:
PODs™ Can Be Integrated Into
 New “green field facilities” investments
 Existing structures (utilization of the shell and utilities)
 Rapid deployment for small and pilot-scale operations
 Multi-product, multi-purpose facilities
 Scalable, capacity ramp-up for commercial scale
 Re-deployment for other purposes than the intended application
 Mobile small scale production facilities for regional expansions
 Contract manufacturing basis to define individual PODs™ to individual
clients
 Any containment needs to create a clean space inside or to protect
the environment from what is inside the POD
 Mobile surgery or patient treatment systems or centers
Performance Comparison
PODs™™
Traditional
Offsite Build
Modular
Panel Wall
Cleanroom
Isolator
Based
All pharma classifications possible
✓
✓
✓
Robust (durable)
✓
✓
✓
✓
✓
✓
significant user interaction
✓
✓
✓
Fully integrated
✓
Lower cost of capital
✓
✓
✓
Can be used in ‘gray space’
✓
✓
✓
✓
✓
Provides multi-level containment for
equipment and processes
✓
Can accommodate equipment with
✓
Simultaneous gray space |
cleanroom build possible
✓
Scalable (easy to add additional processes)
✓
Can be re-purposed and re-configured
✓
Portable (can be moved “as is”)
✓
Self-contained
✓
✓
Low cost commissioning, qualification &
validation
✓
Flexible use (re-arrangement of process
elements)
✓
Designing the Future
of Biopharmaceutical Processing
Clinical Timelines and Facility Requirements
POD™ based facilities can be designed, built and validated faster than conventional solutions at significantly lower cost (according to a case study ~58% of traditional site).
PODs™ provide unmatched manufacturing flexibility and the assurance of a commissioned environment. PODs™ can also be leased to further reduce the risk of failure related costs.
To a biopharmaceutical manufacturer this means reduced:
 Risk




Capital investment
Cost to operate
Time to market
The possibility to regain the investment
A Typical Workflow
PODs™ can be designed, built, supplied and commissioned much faster than conventional facilities. The key
to success in being expeditious is the close team work together with our clients. Your success is our success.
Designing the Future
of Biopharmaceutical Processing
Designing the Future
of Biopharmaceutical Processing
6161 Imperial Loop
College Station, TX 77845
Telephone
855.751.GCON
Fax
979.822.2623
Mailing Address
P.O. Box 15922
College Station, TX 77841
e-mail
[email protected]
Sales and Product Inquiries
e-mail
[email protected]
Website
www.gconbio.com
Check our leasing options
Media
Telephone 979.314.7452
e-mail
[email protected]
Vendors and Channel Partners
Telephone 979-314-7473
e-mail
[email protected]
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