POD MOD
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FREQUENTLY ASKED
QUESTIONS

 

01

What is a POD®?

G-CON POD® is a prefabricated cleanroom unit, built off-site and prequalified via a Factory Acceptance Test (FAT). These units come in different configurations (fully functional, autonomous unit or interconnectable to an on-site HVAC system) and sizes (single POD, POD clusters, ballroom types, etc.) PODs are delivered to the customer’s site where they are installed and undergo a Site Acceptance Test (SAT). PODs can then be utilized in the manufacture of a broad range of drugs and therapeutics. PODs are mobile, flexible and scalable systems and unlike traditional cleanrooms that are built as a typical construction project onsite. PODs are sold as a fully functional cleanroom product.

02

What makes PODs different from other modular cleanroom options?

G-CON builds prefabricated cleanrooms off-site using a well-controlled ISO-9001 manufacturing approach. G-CON completes the design, build, and qualification process by utilizing standardized pre-engineered POD designs, saving significant time and money for customers. In the future, when PODs are mass produced, costs will be further reduced, and fully functional cleanrooms will be available even faster. Ultimately, when a customer buys a POD, it is similar to buying a car. It is fully functional. Car buyers don’t buy parts or redesign cars not knowing the outcome. That is the current, traditional approach in cleanrooms. Infrastructures are designed a new and assembled at the site without certainty as to whether it will ultimately work. The G-CON approach is faster and assures more consistent quality than other approaches.

03

What are the options for Air Handling Units (AHUs) and redundancy?

PODs are provided with a single AHU. If redundancy is required, dual Direct Drive Fan/Motor units in a single
AHU can be provided.

04

Are corridors provided with PODs?

Yes, G-CON can provide either POD based corridors or GCCC modular wall panels. The POD(s) can also be
docked to a third-party-built corridors. The G-CON Design Consultant team will determine the best approach in
terms of quality, speed and cost during the project scoping.

05

Does the corridor have its own air handling system? Or does it need one?

HVAC zoning is determined during the project scoping.

06

Is a low temperature POD available?

Such a requirement is outside the scope of current G-CON offerings. However, a third-party cold room can be
connected to a POD system.

07

What are the environmental conditions required to run a POD at standard settings and can the standard set- tings be utilized in warmer or colder regions?

The host building envelope must provide a supply air temperature of 50°F-80°F and humidity of 40%-60% either from the building environment or directly from a make up air handler system. If these conditions cannot be met by the host facility, the POD can still achieve the standard settings but some configuration to the air handling equipment may be required.

08

Are the interior walls of the POD fire rated?

Standard POD finishes have an ASTM E84/NFPA 255 Flame Spread Index of 15, Class A (the lowest Flame Spread class) and a Smoke Development Index of 5. POD walls are constructed with an aluminum frame and cladding surrounding a non-combustible core material spanning the entire wall thickness. The Flame Spread Index is subject to the equipment utilized within the POD. If low flammable spread index and heat expressing components are used in the POD, it is estimated that the POD will withstand fire for two hours. However, this number is greatly reduced when highly flammable material and equipment are used.

09

I have a piece of process equipment that is very tall. Will it fit in a POD?

Our standardPOD sizes have approximately 9’ of clearance within the cleanroom area. A customized POD with a
high hat or a customized megaPOD can accommodate even taller equipment (2000L bioreactors, spray driers,
etc.) Additional design and manufacturing costs may apply.

10

I have a very heavy piece of process equipment. Can it be installed into a POD?

Yes, standardPOD can accommodate heavy pieces of equipment (centrifuges, etc.) without modification. For extraordinarily heavy pieces of equipment, a reinforced floor section can be provided. Additional costs may apply. If process equipment has specific vibration requirements above standard tolerances (e.g., scales), structural accommodations can also be made.

11

What is the maximum floor load capacity?

The maximum floor load capacity can vary based on the load conditions. The three common loading scenarios
are stationary concentrated load (1,250 psi), evenly distributed load (500 psf), or moving concentrated load
(1,250 psi). These three loading conditions would need to be evaluated together to verify a maximum loading
capacity, based on the customer’s process equipment.

12

Can a POD be shipped to any location?

Yes, PODS arae designed to be transported throughout the world. G-CON works with the client during the
design phase to identify potential logistics issues and utilizes the support of our global transportation partners
when needed.

13

Where are PODs made?

PODs are produced in College Station, Texas, USA and in Castlecomer, Kilkenny Ireland.

14

How long does it take to manufacture a standardPOD? (What is the lead time?)

standardPODs (with no modifications) can be shipped in 3 months or less.

15

Is the POD control system compatible with my Building Management System (BMS)?

Yes, POD control systems can communicate (“handshake”) with virtually any BMS. Additional programming costs may apply.

16

Is the POD control system compatible with the automation software in my process equipment?

The PODs have a BMS (Building Management System) but not a PAS (Process Automation System). We can provide network drops for process equipment or connect the equipment to an EMS (Environmental Monitoring System) for data capture.

17

What is the expected life of a POD?

PODs have exceptional mechanical stability and the longest used POD has been in use for 13 years. Moreover, it has been reused/transported three times without any structural issues. The aluminum structure is corrosion resistant and is not susceptible to rouging or rust. In addition, the cleanroom surface, if damaged, can be easily replaced and does not allow mold or microbial contamination under its surface, as occurs in other wall surface options.

18

Can PODs be moved?

Yes, every POD® is equipped with air bearings. When air bearings are connected to a compressed air source, PODs can be easily moved into, within, and out of a facility. Air bearings allow the POD to float like a hovercraft.

19

Can PODs® be installed on a higher floor of a build- ing than the ground floor?

Yes, PODs can be lifted onto a higher floor by a crane. This has been accomplished for a project in Marburg, Germany.

20

I have a piece of process equipment that is very tall. Will it fit in a POD?

Our standardPOD sizes have approximately 9’ of clearance within the clean- room area. A customized POD with a high hat or a customized megaPOD can accommodate even taller equipment (2000L bioreactors, spray driers, etc.) Additional design and manufacturing costs may apply.

21

Can a POD be decontaminated?

Yes. VHP systems can be integrated into PODs or mobile VHP units can be brought into PODs. POD standard materials of construction are compatible with VHP although if VHP decontamination is routine and includes ductwork, stainless steel duct is recommended. Other decontamination systems such a chlorine dioxide can also be integrated.

22

Do you offer single-use processing equipment with PODs?

We do not supply process equipment, but we do work with our clients to accommodate any process or unit operation in PODs. We also offer a process equipment unit operations catalogue so that process equipment dimensions and utility requirements are readily viewable.

23

What utilities are required to run a POD?

Typical utilities for PODs include electricity (480V/3P and 208V/3P), chilled water, hot water, and make up air. PODs with electric reheat and DX/condenser systems can be provided when hot or chilled water are not available.

24

What is the maximum load bearing of the air bearings?

Each POD air bearing system can lift 48,000 lbs. in a standard configuration.

25

What pressure and air quality is required to operate the air bearings?

There are 8 air bearings per subPOD® in our standard 8.5’ – 12’ wide units. Each air bearing requires 25 cfm (42.5 m3/h) at 30 psi (2 bar) to operate properly. Therefore, a minimum of 200 cfm (340 m3/h) at 30 psi (2 bar) is required for each subPOD.

26

Does the POD’s air handling system work in single-pass or recirculation mode?

G-CON can support both recirculation and single pass.

27

How are the HEPA filters changed?

HEPA filters can be changed from within the process space.

28

What are the materials of construction of PODs® and how do these compare to traditional cleanroom options?

The outer structure of the PODs is aluminum. Ceilings and walls are uPVC coated panels, preferable from G-CON Clean Components (GCCC). Flooring is cleanroom rated such as Nora. Alternative flooring, walls, ceilings and doors are available upon request.

29

What air qualities are provided by PODs?

PODs can provide in customer specified air qualities from CNC to ISO 5.

30

Are PODs more expensive than stick-built cleanrooms?

PODs are very cost competitive with stick-built and panel-built cleanrooms when the total cost of ownership is considered including accelerated depreciation, portability, and possibility of reselling or repurposing the cleanrooms. Further, in many regions known for biotech and pharma, PODs will cost less as a turnkey solution (design, fabrication, factory test, shipping, site testing) than onsite built options. To learn more about the total cost of ownership benefits of PODs, please contact us for our Total Cost of Ownership (TCO White Paper. Other references are:

• Big pharma urged to share plant construction data because projects are late and over budget, Global Construction Review, 2021
• How data can improve pharmaceutical construction project performance, D’Orlando, J., Turner & Townsend, 2021
• Rapid Deployment of Manufacturing Options – An Analysis of Risks and Benefits, Sinclair et. al, Bioprocess International, 2021
• Modular Facility – A Lean Case Study, Mangum, W., IPS, 2021
• Modular construction: From projects to products, Bertram, N. et. al, McKinsey, 2019

31

Are traditional built cleanrooms better for custom designs?

No. PODs can be provided in many configurations to meet client requirements. Typically, the only barriers to POD use are the clear height to the shell building roof structure (minimum 14’ clear) or tight column spacing (less than 20’ x 20’ spacing). If our Design Consulting or G-CON Building Solutions team determines that POD structures are not conducive to the project requirements, other cleanroom solutions from G-CON Clean Components can be considered. Please refer to the section on Host Facility Requirements.

32

Do I have to reinforce the roof of the host facility for any POD components as is required with modular and stick built options?

No, the POD structure completely supports all ductwork, lights, fire protection, process piping, air handler, finished ceiling, etc. The cost of support for modular and stick built approaches can be hundreds of thousands of dollars. Many times, with modular panel built options, a separate steel structure must be built within the host facility to support the system.

33

Does G-CON take full accountability of the performance and build of the cleanrooms?

Yes, compared to stick built or modular approaches, PODs do not require numerous subcontracted trades onsite. As such, the risk of scope gaps and untimely delivery is minimized.

34

Can PODs be stacked?

Yes, but only two PODs can be stacked on top of each other. Stacking PODs is possible when the process equipment requires higher clear finished ceilings. However, a two-story POD for working/processing is not available in a stacked POD arrangement.

35

Do PODs communicate to the host facility?

Yes, a typical installation requires that the POD HVAC control system communicates with the host facility control system through hard wire or BACnet. PODs can also communicate through OPC/UA protocol to PI servers for data transfer. PODs can send email alerts and can also provide remote access to the HMIs.

36

How are utilities supplied to the POD?

Connections to utilities are made at the rear or top of the POD and G-CON manages distribution within the POD. For PODs expected to be moved on a frequent basis, “no drip” quick connectors can be provided for an additional cost.

37

Does G-CON implement new technology into PODs?

We constantly evaluate new technologies and processes. We strive to continuously improve, which leads to faster lead time and higher quality PODs.

38

Can PODs be customized?

Yes, PODs can be designed to meet our client’s needs. Whether it be specialized equipment or host facility constraints, PODs can be customized for any situation.

39

What other types of POD support spaces do I need in my host facility?

The need for support spaces depends on several factors such as the overall process, the type and amount of raw materials, the number of operators, the need for scalability, ect. G-CON can assist in this process and develop layouts to serve as an initial plan with a budgetary estimate when the process is under initial development.

40

Is it possible to add to an existing G-CON POD set?

Yes. PODs are scalable so that increased production can be accomplished when needed. Additionally, PODs can be designed such that new units can be installed while the existing cleanroom space is still operational.

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