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Continuously circulating 900 gallons of water per hour, this
water-for-injection (WFI) system is fed by a reverse osmosis water stream. A 750-gallon holding
tank assures availability in times of high demand. Heat circulation loop design allows equipment
cleaning with WFI grade water.
Facility Features
Our 104,000-square-foot facility was specifically designed and
engineered for the rigorous requirements of manufacturing products for cell culture in large
scale -- including aseptic liquids, sera, reagents, dry powder media and salts. Among the features:
* Cell culture products are produced under cGMP conditions in compliance with FDA guidelines.
All critical systems, equipment and processes are fully validated.
* Manufacturing, packaging, storage, shipping and support systems are dedicated to large volume product needs.
* Building designed to prevent cross contamination with air segregation and process control.
* Water-for-Injection (WFI) is available for preparation of liquid media and cleaning.
* Clean-in-Place System services all major production equipment, from tanks and
lines to mills and blenders.
* Product purity is protected
with Class 100, 10,000 and 100,000 air -- servicing all critical sampling, production and packaging areas.
* Dedicated high-bay warehouse with storage capacity of 2,200 pallets. Raw material and
finished product are divided into carefully controlled room temperature, cooler and freezer areas.
* Isolated expansion area for planned animal-protein-free processing.
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Powder Manufacturing
The powder manufacturing
area of the cell culture facility, completely segregated from the liquid production area, includes dedicated equipment for weighing, milling, blending and packaging of powder media or buffers.
Some features include:
* State-of-the-art technology. Newly developed air classification milling (ACM) for
tighter control of particle size and continuous processing.
* Flexible capabilities to effectively handle quantities ranging from
kilograms up to single 3,500 kilogram batches -- and shipping in bulk containers or filling into
smaller pouches or bottles.
Powder Media Processing Area
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1. Warehouse Ambient
2. Warehouse 4°C
3. Warehouse -20°C
4. Stairs
5. Restrooms
6. Administrative
7. Receiving/Shipping
8. Utility
9. Administrative
10. Elevator
11. Restroom
12. Waste Management
13. Liquid Sample
14. Air Lock
15. Powder Sample
16. Ball Milling
17. Air Lock
18. Ball Milling
19. Ball Milling
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20. Administrative
21. Air Lock
22. Future Expansion
23. Storage
24. Gown In/Out
25. Utility
26. Air Lock
27. Raw Material Staging
28. Equipment Cleaning
29. Clean Staging
30. Weigh Up
31. Personnel Decontamination
32. Equipment Decontamination
33. Waste Management
34. Weigh Up
35. Air Class Milling
36. Weigh Up
37. Delump
38. Milled Staging
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Two separate air locks allow access to powder processing area. Raw materials and
chemicals are staged, then weighed in controlled environments. Two decontamination rooms support milling and
blending suite. Finished product passes through air lock to the warehouse.
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Liquid Manufacturing
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Like the powder production area, our cell culture facility's aseptic liquid manufacturing area is totally isolated with dedicated air handling.
Major features include:
* Manufacturing zone for production of liquid media containing serum or
animal-derived proteins.
* Space available to accommodate manufacturing expansion for animal-protein-free
processing.
* Validated processes to filter and heat-inactivate sera in up to 2,000 liter "true-pool"
lots.
* Capabilities to meet liquid-fill needs. Bag filling to 500
liters in lot sizes to 10,000 liters use high throughput Steam-in-Place system -- from filling standard media
bottles to small volume custom orders.
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Proprietary steam-in-place sterilization for multiple bag filling
capabilities. Flexibility to fill 10 liter up to 500 liter sizes.
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Liquid Fill and Formulation Area
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1. Warehouse Ambient
2. Warehouse 4°C
3. Warehouse -20°C
4. Stairs
5. Restrooms
6. Administrative
7. Air Lock
8. Analytical Lab
9. Administrative
10. Equipment Storage
11. Utility
12. Administrative
13. Administrative
14. Future Expansion
15. Elevator
16. Ambient Storage
17. Thawing
18. Cooler Storage
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19. Freezer Storage
20. Serum Processing
21. Media Production
22. Raw Material Staging
23. Component Preparation
24. Equipment Preparation
25. Autoclave
26. Aseptic Fill
27. Serum Packaging
28. Air Lock
29. Gown In
30. Gown Out
31. Air Lock
32. Liquid Processing
33. Clean Room
34. Custom Formulation Packaging
35. Bag Packaging
36. Mechanical
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The liquid processing rooms and custom bulk formulation areas are separated from raw
material staging by air locks. Filtration and flow of sterile product to the aseptic
filling suites or the bag fill area allow packaging flexibility.
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Built to Serve
Our new cell culture facility was engineered with built-in flexibility to meet your
requirements today and to serve your future needs. Manufacturing space can be expanded to meet growing requirements for quality products in large scale volumes.
In addition, the facility is home to our staff of dedicated professionals
with extensive industrial experience in research and development, manufacturing, quality control andquality assurance.
We are eager to work with you in developing large-scale solutions for all
your industrial cell culture raw material needs. We want to partner with you to help you succeed.
Sigma-Aldrich has made a substantial investment to meet your needs in the
industrial scale market with this fully validated facility. Learn why Sigma is qualified to
lead...with a respected reputation for quality cell culture products and unsurpassed service.
Quality Systems
- FDA-registered facility.
- Quality systems based on ISO 9001 standards.
- Operates in full cGMP compliance.
- Broad-based analytical support for full product range.
- Fully validated.
Product quality is ensured through process and design control. Our
large analytical services staff performs a wide variety of assays on all the products we produce.
Custom QC testing and assay design development are available through our analytical services department.
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Your Global Partner
Sigma-Aldrich Fine Chemicals - Your Global Manufacturing Partner.
Sigma-Aldrich Fine Chemicals provides you with dedicated development,
scale-up manufacturing and analytical expertise at all of our facilities, in five countries worldwide.
We understand your concerns as your project travels through its
development cycle. Local access to our global capabilities can provide you with:
* Product produced or available locally in the market
* Ease of communication
* Ease of technology transfer
* Understanding of local and global issues
Our broad-based manufacturing capabilities and global expertise
make Sigma-Aldrich Fine Chemicals the right partner to help you accelerate your product to market.
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